Kenny Workman

The GLP-1 space has continued to explode, with the potential for impact expanding to cardiovascular risk, sleep apnea, and liver disease. So who are the emerging players poised to challenge Lilly and Novo? The incoming players to watch are a mix of startups and incumbents. In the startup realm, Viking Therapeutics, Inc., and Altimmune, Inc. have gained significant attention as their GLP-1 candidates demonstrate solid weight-loss outcomes. For San Diego based Viking, weekly doses of VK2735 delivered weight loss of up to 13% compared to placebo in a Phase 2 trial. Perhaps most exciting, the weight loss did not plateau at any time during the 13 week study, suggesting longer duration doses would result in further weight loss. Meanwhile, Altimmune's Pemvidutide (being studied for both obesity and MASH) is on track for an end of phase 2 FDA meeting in Q3 of this year. Notably, Pemvidutide has showed promise in limiting the amount of weight loss derived from muscle, which is a notable problem with the existing GLP-1s. A recent phase 2 trial showed only ~25% of weight loss was from lean mass, more in line with the ratio seen in typical diet & exercise programs. There are also several incumbents working hard to establish their presence. Roche's $2.7B acquisition of California-based Carmot Therapeutics, Inc. Therapeutics in December and Amgen's MariTide are both notable. Roche recently announced data from a Phase 1B study for CT-388 showing placebo-adjusted weight loss of ~19%, with 85% of participants seeing weight loss of more than 10%. Not to be left out, Amgen has recently advanced MariTide into Phase 2 studies, with Phase 1 results published in February showing weight loss of up to 15% in 12 weeks, with some dosage levels only required once a month. To have a credible chance at challenging the existing market leaders, new GLP-1s will have to demonstrate meaningful improvements on the following: 1. Dosage - most approved therapies today (with the exception of Rybelsus) are subcutaneous injections, given weekly. Having an easier form (tablet) or frequency (bi-weekly or even monthly) would be a big advantage. 2. Preservation of lean muscle mass - helping patients derive weight gain from regular adipose tissue instead of muscle mass. 3. Benefits beyond weight loss. Novo's recent FDA label expansion for Wegovy for reducing the risk of serious cardiovascular events provides a blueprint of how to expand the area these medicines can be helpful in. While there are many companies active in the space, it's worth noting just how large a lead Lilly and Novo have in this future $100B market. A recent GlobalData report noted that even by 2029, these two giants will have ~80% of the market between them. That said, 20% of a $100B market is still a sizable prize for other innovators, and continued innovation will only help patients.

412

19 Comments

Wow - 2 ex-Meta employees launch EvolutionaryScale landing $142m to advance AI in biology. EvolutionaryScale has introduced ESM3, a cutting-edge language model for biology that predicts protein sequences, structures, and functions. This model can simulate millions of years of evolution, generating new proteins with potential applications in medicine, research, and sustainability. ESM3 represents a significant advancement in AI's ability to design and engineer biological systems. There will be comparisons with AlphaFold3, intrigued where this goes... https://lnkd.in/dhtQDtsA #AIinDrugDiscovery #genomics #proteomics

3

1 Comment

We end every episode of The Biotech Startups Podcast by asking if there’s anyone our guest would like to thank. Without fail, they thank their families – Mom, Dad, grandparents, spouses, partners. Often, there are shoutouts to early mentors, advisors, or colleagues as well. What all those people have in common, is that they’re the ones who believed in them and bet on them early. Whether it was family support during their formative years... Extraordinarily patient spouses/partners... Professors who said “Sure, come join my lab,” before they really knew a bunsen burner from a beaker… What we seem to attract in the life sciences, is a ton of good will, gratitude, and a willingness to pay it forward. I might be biased, but it always feels to me like we might have even more of that than any other industry. Maybe it’s the mission-minded nature of the life sciences. Maybe it’s something else. But it’s clear we’re extraordinarily lucky to have people willing to bet on us early and often. As far as pattern recognition goes, it’s one I’m happy to see again and again. #biotechnology #lifesciences #thebiotechstartupspodcast

32

2 Comments