Clinical Trial News

Bavdegalutamide (ARV-110), a PROTAC protein degrader, selectively degrades wild-type and mutant AR with high potency, showing superior activity over enzalutamide in cell-based systems and AR-expressing xenograft models. It effectively inhibits tumor growth in enzalutamide- and abiraterone-resistant models and enhances abiraterone activity. Bavdegalutamide is the first PROTAC degrader in clinical trials for mCRPC.

Biophytis presented its OBA program with BIO101 at the 17th SCWD congress, highlighting its potential to prevent GLP-1RA-induced muscle loss in obesity. Results from the Quinolia study showed reduced fat mass and maintained muscle strength in 20-hydroxyecdysone-treated patients. A phase 2 OBA study targeting obese patients with GLP-1 RAs is planned for 2025.

2024 saw significant clinical trial activity, with Phase I and II trials dominating. Notable successes included Gilead's lenacapavir for HIV PReP, Scholar Rock's apitegromab for SMA, and Lilly's Zepbound for obesity. However, failures like Amylyx's Relyvrio for ALS and Pfizer's DMD gene therapy highlighted challenges. Eisai's Leqembi for Alzheimer's also showed positive results.

Vivozon Pharmaceutical plans to launch non-narcotic pain reliever Unafra in 2025, targeting KRW 100 billion in sales within five years. Unafra, approved by MFDS, is a first-in-class drug with multiple mechanisms for pain relief, aiming to replace opioid painkillers in post-surgical care. Vivozon is discussing domestic commercialization with Boryung and planning global expansion, including U.S. phase 3 trials.

Vertex Pharmaceuticals' suzetrigine showed no more effectiveness than placebo in relieving lumbosacral radiculopathy pain, despite company claims of statistical significance. Vertex plans Phase 3 trials, aiming to minimize placebo impact. Suzetrigine, under FDA review for acute pain, blocks peripheral pain signals without opioid-like effects.

2024 saw significant clinical trial results, including successful Phase III trials for Gilead's HIV PReP lenacapavir, Scholar Rock's SMA drug apitegromab, and Lilly's obesity drug Zepbound. However, failures included Amylyx's ALS drug Relyvrio and Pfizer's DMD gene therapy. GlobalData reports most trials were Phase I (40.92%) and II (36.28%), with 7,089 completions in 2024.

Sanofi and SK Bioscience expand collaboration to develop next-gen PCVs for pediatric and adult populations, co-funding R&D. Sanofi pays €50m upfront, with success-dependent milestone payments. Sanofi to commercialize globally except South Korea, where SK Bioscience has exclusivity. Phase III testing of PCV21 vaccine begins next week. Despite vaccination programs, invasive pneumococcal disease persists, driving market growth.

AstraZeneca's Tagrisso approved by EU regulators for EGFR-mutated NSCLC, reducing disease progression risk by 84% in LAURA trial. This marks the fifth major approval globally, with applications under review in China, Japan, and others.

Vittoria Biotherapeutics announced the first patient dosed in its phase 1 trial of VIPER-101, an autologous cell therapy for relapsed/refractory T cell lymphoma, developed with the Senza5 platform featuring CD5 modulation and a 5-day manufacturing process. The therapy aims to enhance efficacy and safety, offering new hope for patients with limited treatment options.

HKBU and Shanghai Sixth People's Hospital discovered an aptamer, Apc001, effective for X-linked hypophosphatemia (XLH). Granted Orphan Drug and Pediatric Rare Disease Designations by the FDA, Apc001 is set for clinical trials in Mainland China and the US.