Daily Snap - 1. October 2025

 

Good morning! Metsera, the obesity company that Pfizer acquired last week for $4.9B, has reported new data described by experts as “remarkable!” The phase 2b for its lead GLP-1 candidate MET-097i shows a placebo-adjusted 14.1% weight loss at 28 weeks, surpassing results seen with semaglutide and approaching Eli Lilly’s tirzepatide. Even better, longer-term analysis indicated continued weight loss with no plateau reached, while gastrointestinal side effects were limited and discontinuation rates were lower than for competing drugs. MET-097i will now advance into phase 3 trials. Rumor has it that Pfizer executives are losing more sleep than weight, but only because they’re too busy celebrating.

Enjoy today’s read!

—Joachim E. 

SNIPPETS

What’s happening in biotech today?

📞 FDA chat pending: Opus Genetics has released early pediatric data from its gene therapy program targeting Leber congenital amaurosis type 5 (LCA5), a rare eye disease affecting around 200 people in the U.S., and plans to meet with the FDA in Q4 to discuss next steps. The AAV8-based gene therapy, which builds on technology used in Roche’s Luxturna, showed promising vision improvements in three adolescents, with gains ranging from 0.2 to 0.7 logMAR within three months. Safety results were consistent with earlier adult trials, showing no drug-related adverse events. Opus aims to pursue an accelerated development path if pediatric efficacy aligns with adult outcomes.

 🧠Tau takedown: AC Immune has reported promising results from a Phase 1b/2a clinical trial evaluating two Tau-targeting immunotherapies, ACI-35.030 and JACI-35.054, for early Alzheimer’s disease. ACI-35.030, developed using the company’s SupraAntigen platform, elicited a rapid, robust, and sustained polyclonal antibody response specifically against pathological Tau proteins, with high responder rates maintained through week 74 in high-dose groups. Unlike JACI-35.054, which showed inconsistent responses and also targeted normal Tau, ACI-35.030 demonstrated greater specificity and required less frequent dosing. Both therapies were well tolerated, with no significant safety concerns. ACI-35.030 has been advanced to a larger Phase 2b trial involving around 500 participants.

💉Fuuusion: Barinthus Biotherapeutics is entering a reverse merger with UK-based Clywedog Therapeutics to form a new company operating under the Clywedog name and trading on Nasdaq under the ticker “CLYD.” The merged entity will focus on advancing three clinical programs targeting diabetes and autoimmune diseases, with Clywedog shareholders owning 66% and Barinthus shareholders 34%. The pipeline includes CLY-101 for Type 1 and Type 2 diabetes, CLY-201 for T-cell mediated inflammation, and VTP-1000 for celiac disease. Barinthus CEO Bill Enright will lead the company, with funding from existing and new investors projected to support operations through 2027, pending shareholder approval of the merger.

🧫Stem cell scrap: KALA BIO announced that its Phase IIb CHASE trial of KPI-012 for persistent corneal epithelial defect (PCED) failed to meet its primary endpoint of complete corneal healing, with neither tested dose showing significant efficacy over placebo. As a result, the company will discontinue development of KPI-012 and its mesenchymal stem cell secretome platform, reduce its workforce by approximately 51% (19 employees), and explore strategic alternatives with its secured lender. Despite earlier promising Phase Ib results, the latest trial did not support further development. KALA held $31.9 million in cash as of June 30, sufficient to fund operations into early 2026.

💸Royalty reroute: AnaptysBio plans to split into two separate publicly traded companies by the end of 2026, with one focused on its clinical-stage biopharma pipeline and the other on royalty-based revenue. The royalty-focused entity, which will operate with minimal infrastructure, will manage income from drugs such as GSK’s Jemperli, expected to generate substantial royalties over time, and Vanda’s imsidolimab, with potential milestone payments and a 10% share of future net sales. Meanwhile, the biopharma company, led by current CEO Daniel Faga, will retain pipeline assets including rosnilimab, ANB033, and ANB101, and is expected to be financially stable for at least two years post-split.

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