Ep. 353 - Prasad Departure and Future of Fibrosis Therapies
Episode
37 min
Read time
2 min
Topics
Investing, Fundraising & VC, Leadership
AI-Generated Summary
Key Takeaways
- ✓FDA Leadership Risk: When one or two individuals centralize drug approval decisions outside established review team structures, the entire regulatory system becomes vulnerable to political interference. Biotech investors and companies should monitor not just who replaces Prasad at CBER, but whether the successor restores multi-reviewer consensus processes or continues single-decision-maker precedent set under McCarrie.
- ✓IPF Pipeline Timing: With over 20 programs in phase two targeting IPF across mostly first-in-class mechanisms, a wave of proof-of-concept data is approaching. Companies are shifting strategy downstream in the fibrotic cascade to improve therapeutic index, avoiding broad pathway suppression that disrupts normal wound healing — a key lesson from prior phase three failures in this indication.
- ✓Fibrosis Reversal Signal: Evidence from MASH liver fibrosis trials showing partial reversal has re-energized the broader antifibrotic field. Boehringer's December approval of nerandomilast marks the first new IPF drug in a decade. Investors should track whether downstream pathway targeting or novel modalities beyond small molecules can replicate liver fibrosis reversal results in pulmonary settings.
- ✓Psychedelic Trial Design Flaw: Siebert Hellas reported 67% remission at six months for DMT compound in treatment-resistant generalized anxiety disorder, yet shares fell 34%. The collapse stemmed from pooling two dose groups that performed identically, eliminating dose-response evidence and raising expectation-bias concerns. Future psychedelic trials require placebo arms or validated active comparators to produce credible efficacy signals.
- ✓Amylin Tolerability Differentiation: Zealand Pharma's petrelintide showed placebo-adjusted 9% weight loss at 42 weeks — roughly half of Lilly's oleoylethanolamide benchmark — but reported near-zero vomiting, diarrhea, and constipation, with treatment discontinuation rates lower than placebo. Given that roughly 80% of GLP-1 patients discontinue within one year due to GI side effects, tolerability-optimized amylins may capture a durable second-line market position.
What It Covers
BioCentury This Week examines Vinay Prasad's second FDA departure and its structural implications for CBER leadership, the expanding phase two fibrosis pipeline targeting IPF with over 20 programs across novel mechanisms, plus clinical setbacks for psychedelic GAD therapy and Novo Nordisk's Cagrisema head-to-head obesity trial against Lilly's tirzepatide.
Key Questions Answered
- •FDA Leadership Risk: When one or two individuals centralize drug approval decisions outside established review team structures, the entire regulatory system becomes vulnerable to political interference. Biotech investors and companies should monitor not just who replaces Prasad at CBER, but whether the successor restores multi-reviewer consensus processes or continues single-decision-maker precedent set under McCarrie.
- •IPF Pipeline Timing: With over 20 programs in phase two targeting IPF across mostly first-in-class mechanisms, a wave of proof-of-concept data is approaching. Companies are shifting strategy downstream in the fibrotic cascade to improve therapeutic index, avoiding broad pathway suppression that disrupts normal wound healing — a key lesson from prior phase three failures in this indication.
- •Fibrosis Reversal Signal: Evidence from MASH liver fibrosis trials showing partial reversal has re-energized the broader antifibrotic field. Boehringer's December approval of nerandomilast marks the first new IPF drug in a decade. Investors should track whether downstream pathway targeting or novel modalities beyond small molecules can replicate liver fibrosis reversal results in pulmonary settings.
- •Psychedelic Trial Design Flaw: Siebert Hellas reported 67% remission at six months for DMT compound in treatment-resistant generalized anxiety disorder, yet shares fell 34%. The collapse stemmed from pooling two dose groups that performed identically, eliminating dose-response evidence and raising expectation-bias concerns. Future psychedelic trials require placebo arms or validated active comparators to produce credible efficacy signals.
- •Amylin Tolerability Differentiation: Zealand Pharma's petrelintide showed placebo-adjusted 9% weight loss at 42 weeks — roughly half of Lilly's oleoylethanolamide benchmark — but reported near-zero vomiting, diarrhea, and constipation, with treatment discontinuation rates lower than placebo. Given that roughly 80% of GLP-1 patients discontinue within one year due to GI side effects, tolerability-optimized amylins may capture a durable second-line market position.
Notable Moment
The Moderna flu vaccine decision this summer creates an unresolvable political trap for FDA: approving it will energize the MAHA base against the administration, while rejecting it causes industry and public health backlash — and delaying past summer makes timely manufacturing for flu season impossible.
Episode Transcript
It is deja vu all over again as for the second time in the past eight months, Vinay Prasad is out at FDA. What happened and what it means for the agency going forward. Plus how the science has reached a tipping point in halting fibrosis, one of industry's most persistent challenges, and the latest clinical updates on psychedelics and obesity therapies. I'm Steven Hansen, cohost of the BioCentury This Week podcast. And joining me today are my colleagues. Lauren Martz, executive director of Biopharma Intelligence. Selena Koch, executive editor. And Steve Austin, Washington editor. Alright. Well, before we dive into those topics, a few of our colleagues, Jeff Simone and a few others are over in Seoul for our fifth annual BioCentury Bay Helix East West Summit, which is starting today. And launching at the East West Summit, we are excited to introduce a new exclusive opportunity for BioSentry subscribers. Step inside the BioSentry Lounge, a dedicated space designed to connect, recharge, and inspire conversation among industry leaders, Experience unique networking moments, insider insights, and a place to unwind between sessions. Don't wait. Check out more at biocenturylounge.com. Can can we get one of those lounges in Washington? I'm sure we can work something out for you, Steve. I'm sure we can get you get you a little space to relax there. You don't already have one? No. Well, I like the, you know, the unique networking and all that kind of stuff. That that sounds really fun. Well, I'm sure we can figure something out. You know, give give Josh a call. I'm sure he can he can sort you out. But in the meantime, be be before we get Steve his own personal BioSentry Lounge, we're also looking ahead to this year's BioEquity Conference, which is happening in Prague at the May. So if you have any companies that are interested in presenting this year, please do reach out to Jeff for more information on that. Right. So, Steve, you're just getting back from what what I was hoping was, you know, a nice relaxing vacation from what you've told me before we started recording here. Doesn't sound like it was as relaxing as you might have hoped it would have been. You can just decide whether you want to disclose that or not. But, you know, you come back to, Vinny Prasad out at FDA. First off, is this gonna be our last conversation about Prasad at FDA or not? No. Of course not. You know, he's been fired once we you know, now this is the second time. Yeah. Is he gonna come back for a third round? I doubt it. But is he going to just, you know, slink off into the sunset? No. I doubt that also. He's going to definitely be a character who's gonna be in the in the ecosystem for some time. But anticipating your question, you know, why, you know, and why now? Why why why is he fired …
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Books, tools, and gear mentioned in this episode
SignalCast may earn commission on purchases via these links. As an Amazon Associate, SignalCast earns from qualifying purchases.
Products
by Moderna
“The Moderna flu vaccine decision this summer creates an unresolvable political trap for FDA”
by Boehringer Ingelheim
“Boehringer's December approval of nerandomilast marks the first new IPF drug in a decade”
by Eli Lilly
“Novo Nordisk's Cagrisema head-to-head obesity trial against Lilly's tirzepatide”
by Zealand Pharma
“Zealand Pharma's petrelintide showed placebo-adjusted 9% weight loss at 42 weeks”
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