Facing NASH Therapeutic Skepticism with 89bio's Rohan Palekar

When it's time to map out your clinical course , let clinicalleadercom help , and if optimizing outsourcing decisions is what you're after , check out outsourcepharmacom . We're LifeScienceConnect and we're here to help . The non-alcoholic steatohepatitis therapeutics market has seen its fair share of recent tumult .

Despite a couple billion dollars spent annually on research and development , nothing's been approved and in fact the indication has dropped out of many of biopharma's pipeline . Most recently , Intercept Belt on the indication , a move that's spun positive by pointing out the 140 million dollars it will save by shedding the failed candidate .

Prior to that , Gilead and Genfit both dropped out of the race . But while this race to treat NASH is clearly challenging , the reward that will come with completing the race will no doubt be great . By 2029 , an estimated 26 million patients will suffer NASH in the US alone . Some big players Abvy and Novo Nordisk remain in the race .

They're being pushed by a handful of new and emerging biopharma companies , including the one led by today's guest . I'm Matt Piller . This is the business of biotech , and 89 Bio CEO Rohan Pollaker joins me today to unpack why NASH is such a tough business and how 89 Bio plans to beat the odds . Rohan , welcome to the show .

I've got some questions about how you landed where you are today a little bit later on , but I want to start with this . As I mentioned the tumult on the landscape of the NASH therapeutic space , there's been justifiable skepticism that NASH is a treatable indication . Why is that ? Why are we having so much trouble here ?

And in a drug , development is relatively recent . When you think about NASH , the first drugs went into the clinic only 15 years ago . So it's a relatively new field and as more studies are being done with different targets , we're getting much smarter . We're really helping understand what's the true benefit .

Where do you need to target drugs to make a difference on NASH ? At the end of the day and there is no question , there's been a lot of skepticism in this market because there have been some failures along the way . But when you look at it is some of the drugs which failed and you referenced some of the companies who've kind of moved away .

They did not really possibly have a potent drug to see a true therapeutic benefit . And for 89 Bio , I think this is one of the things which is beneficial when you're not first to market , but when you're a fast follower , you can learn from those failures Right . So as we structured our trials and we thought about how to execute the programs .

What are the patient population you want to go after ?

We were much smarter and look in some ways , last year there was data in a very large phase three program from a company , madrigal , with Resmatron right , and that's , I think , given the community a much higher level of confidence because this was a large thousand patient study which showed kind of critical good results and we can talk more about our results .

I think the one last comment I would make , which is why NASH drug development has been tricky , is the endpoints which are used in these trials , and so there's an FDA guidance document on the endpoints which need to be used to get approval for NASH , and these endpoints are based on histology .

You're taking a biopsy of the liver and then you're getting pathologists to read these slides .

It is a highly , highly variable process and so what this does sometimes it makes it trickier to really ascertain the difference between , say , a placebo response and a drug response , and so in some ways reducing that variability becomes critical as you think about drug development .

If you go back 10 years ago we didn't know that , we kind of knew that , but now we've got a much better handle on that . So the way , for example , the way we are reading these biopsy slides is very different than the way , say , intercept read their slides even I'm talking five or seven years ago .

So while I understand the skepticism , I think we're now on the cusp for this category where , as sponsors and drug developers , we become much smarter and there's a lot more optimism today where we sit , versus where we were even five years ago .

Like how are we recruiting for trials when we're targeting an important but asymptomatic disease ?

You put a needle in , you take it out , you read the slide . So how do we decide , or how do the clinical trial sites identify patients who could have NASH ? There is a very high percentage of comorbidities with other conditions which are easily diagnosed . For example , most of these patients are obese . In our studies the average BMI is like 35 .

That's one kind . Very high percentage of them have diabetes . Most of them will have elevated liver enzymes or liver transaminases . So when the patient comes in , you screen them . Do they have diabetes ? Do they have other aspects of metabolic syndrome ? Are they obese ? Do they have elevated ALT ? But then you have to do a biopsy to enroll them .

One tricky part is these non-invasive and some before you do a biopsy which is an invasive measure . They're not a definitive diagnosis and so a lot of patients will get screened for trials and they might not meet the criteria to enter the trial ? Yeah , but given just the size of the patient population with underlying fatty liver disease ?

On NASH , we have had really good success in enrolling trials . For example , the phase 2B study we completed enrolled 220 to 219 patients . 219 was the data . The entire time period and it was only in North America was 14 months . With actual recruitment it was only in about nine months . So we could find those patients yeah .

We've ascertained the skepticism in the space and the challenges that the space has seen . Do you feel like we're at an inflection point , like a turning point , as a skepticism waning and if so , why ?

And beta and I should have mentioned for your listeners is our target is FGF 21 , which is an endogenous metabolic hormone which regulates energy , lipid carbohydrate metabolism in the body and it's also an insulin sensitizing agent . And , importantly , matt this target .

It works directly on the liver , where we take fat out of the liver as well as address the inflammation of fibrosis in the liver , but then more broadly across the entire body , by working on the fatty tissue or the white-tatter post-tissue , we manage lipid carbohydrate metabolism . I should have mentioned that up front .

So there's another company with a molecule , the Phroxifirmin . In September of last year they showed really positive data with an FGF 21 agent . December of last year , as I mentioned earlier , resmetron , which is a chiroid hormone beta agonist , showed really positive data in roughly 1,000 patient phase 3 study .

And then March of this year we showed with 89 bio with our molecule , because the ferment showed really nice efficacy data and in some ways it's the next generation of NASH drugs and people are feeling very optimistic , not just in the KOL community .

There's renewed optimism in the investor community also , and if you look at the valuations just a year ago , concluding our company , you know we were , I think , about three bucks at that time . We're now anywhere between 16 and 20 bucks , right the same with a caro or madrigal .

And then the last one , I would say the investment you're seeing in biopharma , as well as some of the large farmers you referenced , is they're betting on NASH because there's no approved treatment yet . One of them has got past phase 3 , but there's no approved treatment .

Diagnosis is under way , is expected to continue to increase and , as you mentioned , you know the numbers I talked about could be 25 to 30 million by the end of this decade .

So , given all of that , my belief is that skepticism is waning and there's a kind of a renewed hope here that some of these drugs are going to get past the finish line and when they come , to help patients .

So I want to talk about you know what's what is contributing to the fueling of the machine ? I'm going to start with agency with just a general agency question . What is the well one ? Can you , is there a common thread line or you know a common thread ?

You can pull among the failure stories of recent years in this space related to the FDA's decision making or influence on the influence on the companies that have dropped those candidates or not . I mean not as fine . I'm just curious if there's sort of a common thread in terms of the data that's not stacking up .

I think that story was unique , kind of unfortunate for patients , because patients wanted the drug , but in some ways it really came down to the benefit risk profile from the agency's perspective for that specific molecule . So the agency's perspective , which was evident at the advisory committee meeting held in May , is that Nash is a large patient population .

It's a chronic therapy . You're going to be our drugs don't cure the disease . You're going to be on these drugs for a long time . It's asymptomatic and in some instances , especially in the earlier stages of the disease , these patients can continue with no significant adverse outcomes for a long time period . Now once they say serotic , it's a different state .

And so in that specific instance they felt that the benefit observed , which was the improvement in fibrosis , relative to the risks of that molecule , were not in favor of the molecule . And so the agency was , and that's really what it came down to .

At the same time they were very clear Look if there are drugs with a better tolerability profile with good benefit . They reasserted that the guidance document they have provides a path forward for drugs to come to the market . So it wasn't like they shut the door on the development of Nash , it was more so .

Is in that space for that drug , they didn't feel that the benefit risk justified it .

Now , the second thing with the regulators and I wouldn't say this has actually because there's only one drug which is actually filed with the agency and got a rejection the other thing with the agency goes back to what I mentioned earlier , which is the endpoints the regulators are accepting as a measurement for approval , which is a biopsy .

It's variable , I should have mentioned right . You're taking a biopsy which is a very small slice of a very large organ . A liver is a very large organ , highly heterogeneous , and you're relying on humans to read it , and we do know there's wide variability as humans read these slides .

Now there is a growing push in the academic community to use noninvasive tests , so we call them NITs , noninvasive tests . Needless to say , they're more patient friendly right , they're not putting patients through this , but , more importantly , they address the whole liver . They're not just taking this one 10,000th of the liver .

And those conversations are taking place with the agency and I think not to a great extent we're early in those discussions . I think that could be a paradigm shift for drug development as the agency , if they adopt these NITs , it would really change it because it would change the gold standard for biopsies to these NITs .

And you can do it relatively easy in an office with the ultrasound , not very expensive , or you can do a complex MR-elastography , put them in an MRI machine . The other imaging technology which is really important is it's called MRI PDFF , which is protein density , fat fraction . You measure how much fat is in the liver and that starts with liver fat .

So that's one way of doing it imaging . But at the same time there are some really interesting blood based noninvasive tests which are being validated as we speak and there's a series of them and I think if you talk to some of the care-wells , what they like to see is a combination of both .

But at the same time , it's always fascinating to me when a new technology or a new set of technologies or a new technological concept also brings with it the potential to I don't know , for lack of a , to use a colloquial term sort of grease the wheels towards progress , business progress , right For a company like 89Bio , like a technology like that could be a

paradigm shift that enables you know better . Is it a more accurate ? I mean , as far as we know right now , are these NITs a more accurate representation of the biopsy ?

But one of the ways we are addressing the biopsy variability is a unique way we read our biopsy slides and three different people to read them , so that you are not subject to the vagaries of an individual , but you are yet subject to the vagaries of where the needle went into the liver .

If I put someone in an MR machine and take their whole liver , do I get a better picture of what is happening across that entire organ and its impact on Nash versus a particular sliver of that liver ?

What else can you identify about your product that potentially will address some of the previous failures and FDA scrutiny that have been applied to Nash therapeutics ?

And what they've said is , in the non-serotic population , so people who've not progressed into cirrhosis , they will give you accelerated approval based on a biopsy . But to get full approval you need to do outcomes , which is defined as , and there's a multitude of outcome definitions . So what are we doing and what have we learned ?

So I go back to this conversation about benefit risk of the drug . So one is on the efficacy front . It's very clear what they are looking for and kind of a threshold of efficacy . There's two endpoints they look at . One is fibrosis Are you improving the fibrosis ? And the second is are you resolving Nash ?

But it's evident that the FDA , like most of the expert communities , is more focused on fibrosis . But that's what really in some ways results in bad outcomes down the road . So making sure that you're seeing very good data on fibrosis becomes really important .

One of the things I mentioned in our study we're doing is we are having these biopsy slides read by three independent people to reduce some of that variability versus one person reading it . This is the method which actually the FDA is encouraging everyone to do in late stage development have three leaders instead of a single reader .

The second thing in efficacy we're making sure is that the patients we include in our studies have truly got Nash , because think about it I got to bring in someone with a biopsy and then 12 months later I do a biopsy . If I got the wrong person into the study 12 months later I'm not going to show that difference . So that's one aspect .

Now the second aspect is the tolerability and safety . It's very clear they're very concerned about that . Now . To date we've shown really good efficacy but , importantly , we've shown good tolerability and no significant safety events . So they intercept they had what's called Dilly . They had a drug induced liver injury which was highly problematic .

We know exactly what they're looking for and we are monitoring all of that information really closely . So we're building the database so that when we hopefully , if we have positive results when we go to the agency , we can share with them exactly kind of what they are looking for . We are collecting all the non-invasive test markers .

We did it in our phase 2B study . We will do it in our phase 3 study because by the time we complete our phase 3 , the environment might have changed . Some of these non-invasive markers could be approved , and that would really be huge aspect because in a commercial setting they become incredibly important .

Talk to me philosophically about that a little bit . As the leader at 89 bio , who is one of the competitors in this race , what are you after and what are the pros and cons of being one or the other ?

You know , and when I define best drug , it's the data grounded in the efficacy and safety benefits .

I think Nash is a little unique in that , given the complexity of the disease , the heterogeneity of the disease , as well as the growing prevalence and people being diagnosed , I believe this is a category where multiple therapeutic options are going to be needed to address the diverse patient population .

Okay , I think we have a great drug , but there are other good drugs in development . But we're not curing the disease per se , right , we are addressing different facets . Now , I think the beauty is because of her man . Our molecule addresses not only what's happening in the liver but what's happening systemically in the body . We think that's really important .

But when you're , in this case , in a large market , many patients are looking for therapy . There is no question the first to market will gain access to that bowlers of patients who is sitting waiting for the next , waiting for the drug , forget next drug , right , yeah , and we think there's a significant bowlers .

I hear this from clinicians , I hear this from k o also . You're at the academic centers . However , I believe in due course , the better therapeutic product will be more successful , not to suggest that the first player disappears from the market , but over time , physicians will select the best product .

So when we talk to physicians and we do our market research , what are they looking for ? And if I want to put the hierarchy of what they were looking for , first is are you making an impact on the liver ? Are you improving fibrosis ? That's clearly always comes to the top . Second is are you resolving the Nash ?

But then they immediately go to is the drug safe and well tolerated , because I'm going to ask my patient to be on this therapy for a long time period . Third is they ask for are you doing anything to the underlying disease ? Are you changing the metabolic milieu these patients have ? And then finally they go . Is it convenient ?

So when you think about the hierarchy is if I have two drugs and then efficacy on fibrosis , they're similar , but one is improving their LDL and one is improving their glycemic control and their diabetes , and the other drug is not . Yeah , they would rather use that drug even if it came out three years later , right ?

So I think that's how they're thinking about the space , and you know there are analogies you can take . I mean , I think diabetes is a good one I'll use . Right , there are multiple drugs available for diabetes . And tick insulin out for a minute , right , the GLP once came in . The first generation came maybe 2004 , 2005 , sometime .

But the really the good GLP scheme about a decade ago , yeah , okay , Today GLPs are what ? $25 billion , but that doesn't mean the STLT two category has gone away . That's a 10 plus billion dollar . Okay , everyone's a metformin .

Oh , pretty much most people are metformin , right , so I can see something like that happening here , that because none of them are curing diabetes , but they are bringing value in a different way and these drugs came in with a much better efficacy profile .

So here we think FGF 21 , our class , could really be transformative , because to date the FGF 21 class , both my competitor and ourselves , have shown the best fibrosis data , which goes back to what's most important for the clinicians is am I resolving the fibrosis or preventing the progression , but ideally reversing fibrosis ? And we think .

We think at least that would make a huge difference in how they think about treatments .

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You mentioned that fibrosis data and that a non bio is , you know , leading , leading the industry , for you know , effectively at the forefront in terms of that fibrosis data . What I mean , you know there , it's obvious . I'm going to sound , like you know , matt Pillar , master of the obvious right now .

Good , good data obviously attracts investors , but I want to learn a little bit about your investment trajectory . I understand you recently had a follow on offering that came directly on the heels of a data readout , so I want to talk about a little bit about the relationship between those two things and get your perception on that .

You know what , what , how , I guess . How good does that good data have to be to impact the investment scene ? And tell me a little bit about that follow on offering that you guys were able to secure .

But I think what I would say is , in today's market environment not just in biotech , I think the macroeconomic environment where people are shying away from risk good data in our industry means beyond just did you hit statistical significance and show of benefit ? Is the drug , is the data clean ?

And I've come to scholarly say clean means it's unequivocal meaning I can read into it . It's not like you've done three cuts of the data to identify this population work right , is it ? I can look at it and say clearly this drug is working . Does it have the success in the next phase of development ? Is it going to work right ?

So there's a lot of scrutiny with the way the trial's done . How replicable is this data ? Is the safety and tolerability profile good ? People are getting spooked out a little bit about that , right ? So I think people are looking at all the totality of this and , needless to say , what's the competitive environment is a good in the context of where we are .

Two or three years ago , when biotech there was significant money coming into biotech , I think there was more leeway you had .

It was a phase 2B study , 220 patients with F2 and F3 NASH . So fibrosis stage F2 and F3 . And we had tested multiple different doses and what we saw is on the primary endpoint we had like very significant P values . But on fibrosis , which I've referenced now a couple of times , we saw a 20% delta versus placebo 19 to 20% .

The only two drugs who have shown that are the two FGF 21s , just for perspective . Like the intercept drug which went to FDA was like a 12% delta and there's a . And when you look at it on a relative risk relative to placebo , we were three to four times placebo response and the NASH resolution we were like 12 times placebo response .

So the data on efficacy was very clear . But importantly , in addition to those endpoints , on all these other metabolic changes , the investors felt we had really good data . So it wasn't like we lucked out with one biopsy . The totality of the data is what I think impressed them .

The second thing is we had a very nice tolerability profile and so this gave them confidence that in a larger trotty , in a chronic condition , we should get past the hurdle of the FDA . So remember this was before intercept had its advisory committee . We saw benefit on both the study sorry , both the doses we were looking at .

So we are delivering our drug as injectable once a week and once every two weeks and they were impressed with that . And then , finally , the way the trial was designed . While it was a phase two B study , we designed it like a phase three study . We followed the FDA guidance document and endpoints .

We followed the FDA guidance on how to do biopsy reading and it was a well-powered study . So we were able to attract a really large investor base who was significantly over subscribed . And I'll tell you , march was not an easy time . I think we set off the trend . We were the first big raise of this year for the biotech company .

It was $315 million , but it was the conversations we had with investors , meaning it was nearly 5x over subscribed . Once they saw the data obviously you take them through all the nuances they felt really comfortable investing in the company . And I'd say the other thing they felt good about is our company has only been there for five years .

It's not like we've been around for that long and in five years we've taken a preclinical asset all the way through development . And now are in two indications , one already in phase three and then Nash we hope to enter phase three pending regulatory guidance . So they look at it saying good drug .

Here's a management team who has executed , who has a path forward with this drug , and clearly the class FGF 21 is good and this molecule is differentiated . So I think it was a combination of all that which gave investors confidence going into that financing .

Right Mission is we want to change the lives of these patients with serious live and cariometabolic diseases .

So when we developed , you know , we acquired this asset from Teva Pharmaceuticals with preclinical data and we did some things which were interesting , meaning , obviously you do your first in human safety study , but after that we said let's go to the agency and tell them , instead of doing the classic , you know , first in human , then a four-week study , then a

12-week study , then we'll do a proof of concept , we said , can we merge those into one study ? So instead of doing sequential two to three studies , we did a single ascending dose and the next study was our proof of concept study , which gave us a level of confidence to go directly into this large 220 patient study .

Okay , now it's a risk we took , but it was a calculated risk , it wasn't like we were just betting on it , but we generated in those , you know , those studies , all the data we needed . The other thing we did is we diversified and made a strategic bet to go into a second indication which is severe hypertraglous redemia .

So this is patients with traglous rides above 500 . And we had reason to believe our drug should work in that condition . Because we drop fat in the blood , the traglous rides come down . That indication is a more efficient indication from a clinical development perspective , ie in an eight week study you can show benefit .

So in battle to doing Nashmat , we decided to do an eight week study . In that indication we saw very nice changes like 60% reduction in triglycerides on top of therapies . We announced that data last year in June . By end of last year we got the FDA to allow us to move into phase three on that .

So it was more about part was strategy how are we thinking about it ? Part was execution and the creative ways to do trial designs and then keeping everyone focused on what's our mission , I think made a big difference right .

So we got our data in the other indication last June and the company was we need to get FDA approval sorry , fda buying to move into phase three as quickly as possible . So it's a combination of these factors , I believe , which is why we're sitting here today .

I don't I got to be cognizant of our time here , Rohan , but I do want to talk with you a little bit about about cash , about cash management , money management , because I've been having a lot of conversations with the leaders of new and emerging biopharmas lately about this .

You know , like obviously you guys are in a pretty good cash position because that follow on round funding was pretty substantial , but at the same time , you are I want to ask you specifically about this , because you're an IT or , I'm sorry , not an IT , but a finance , finance slash accounting guy right , Like that's what you studied in school , isn't it ? A ?

cash runway responsibility , if you will . 89 Bio takes in a giant sum of money to progress its work in the clinic on X , y and Z . Now what , how ? How is Rohan , the guy who's you know , brought up in the finance world , ensuring that that money is put to good use efficiently and that your cash runway extends as long as it needs to ?

I know , again , a great big , giant question .

I come from the belief which is one of our core values at 89 Bio . Everything we do and we have a core value system . But the two foundation bookends is is it patient oriented and is it science driven ?

Okay , every decision we make is grounded in that , and my belief is , if capital is appropriately allocated to improve patient lives and that's grounded in good science , there is inherent value creation . I'm not saying you'll be 100% of the time , right .

Right , because sometimes science does some work , but as long as you do that in a disciplined manner , I believe everyone wins . Okay , we are pretty careful on how we spend our money , right , you're right , we're in a strong cash position , especially in today's environment , but at the same time I know drug development is expensive and tricky . There are setbacks .

There are things I cannot predict here , sitting here today , right , meaning bad things , unfortunately are surprising things that happen right . So our job as leadership is to make sure we extend the runway to get us to the next critical inflection point .

And I believe if you follow the science and our discipline in that , you give yourself the best shot of doing it . So we , we , we spend money where we think it furthers the science and helps us , right .

So we don't take the approach of just to preserve cash , we're going to cut costs everywhere , because I think in some ways that compromises the program and clearly we would not cut costs where we're cutting corners right , Because that adds undue risk to the program which goes back or goes contrary to my basic philosophy .

Go where the science takes you , go where it's going to help patients and that will be a good thing . I think focus does matter in cash management , where you remain focused , you know , and whether it's my operations team , right , we're a biologic agent . It's expensive to do biologic development but it's critical to the long-term success .

So , because of the firm and the company , so we'll deploy capital there . Right . But at the same time , like I'll give you an example on we have , we licensed second asset in from Teva Pharmaceuticals . It's an IND ready asset but we made a conscious decision to do it . Let's pursue because of Furman .

Let's make sure , because Wes is saying let's invest in two assets and move them all forward . Right , I'm not saying one was right , one's wrong , but that's an example . And we said till we have value , inflection points in . We demonstrate a value here . We should stay focused . Now we're in a different spot . We're moving into phase three .

We've shown we've done it with this asset . We've generated value . Now we can think about other ways in capital deployment . But that's kind of my approach to how we've approached it at our company and we're nimble . I think we've been pretty nimble . We've had our tough times . Don't give me a Everybody has .

We can make a difference to someone else's life . You know , and I worked on everything at J&J all the way from Thailand all the way to Remakade , which was like my last seven years . There was running biological businesses and that honestly excited me .

It gave me a sense of fulfillment and while J&J gave me wonderful training , right , I did multiple different roles , different functions , but that's kind of what got me jazzed about doing it , you know .

What do you got to get done right now , rohan ?

So that's one we think we have a unique opportunity in MASH and so , with the data we have and the capital we've raised , it's now about engaging with the agency and really initiating the phase three program in MASH so one day , hopefully , we can bring that product to market .

I think in parallel to that , we got to scale up and make sure we can manufacture this product , and we've done an amazing job on the manufacturing side . You know it's interesting In our industry we talk so much about clinical data , which is the right thing , but it's all to a nought if you cannot scale up and manufacture this stuff .

Yeah , and that becomes really , really important . It's in biologics . It's very different if you're a chemical entity , and I think the last thing that I'm focused on is scaling up the company . It's a different organization . When you were the scrappy young company who was trying to take a preclinical asset meaning I was the first US employee we built something .

Now it's like we're going to be running multiple studies globally and you got to scale the organization and to me it's not just bringing the people , it's what the culture of the organization is going to be . Are you building that culture and sustaining that as you grow ?

Absolutely , he called that a bigger challenge and you know the developing optimizing the engineering of an antibody , which I can only appreciate , especially to grow a stage like like 89 bios in right now . Yeah Well , congratulations to you on the success so far and I you know I'll be pulling for you in the clinic .

I hope we can follow up on this and maybe have a conversation down the road about progress . You know , hopefully we'll be having . Hopefully our next conversation is going to be about late commercialization strategy . How's that ?

If you believe in the science and you believe in it , you will find ways to finance your company and if you stay true to that , one day hopefully you'll bring benefit to patients , you know . So that's that's kind of what we talk about in my leadership team .

You know there are tough days , there are challenges , but as long as we stay focused on that , you know , and stay nimble , things change , you know . Risk profiles change and you got to react to the market . And I'm not talking just the investment sentiment and talking what happens with the science , what happens with competition .

You know we are thrilled to be in the position we are at today , going into two phase three programs . I don't think five years ago we thought we were going to be so rapidly at the space .

We believed in the drug , we believed in the technology , but now it's about execution , but staying nimble and staying humble about it , you know yeah , excellent , excellent advice and insight .

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