April 25 Quick Takes: Gossamer’s IBD therapy fails Phase II trial
Plus Black Diamond discontinues program and updates from AstraZeneca, Axsome, Eliem, Roche and more
Gossamer Bio Inc. (NASDAQ:GOSS) is looking ahead to a Phase II readout next half for seralutinib (GB002) in pulmonary arterial hypertension after another one of its lead products — GB004 — missed the primary endpoint in the Phase II SHIFT-UC trial to treat ulcerative colitis. GB004, a gut-targeted HIF1A stabilizer, did not significantly improve remission rates compared with placebo. Gossamer is terminating the study’s treat-through and open-label extension portions. Seralutinib, an orally inhaled PDGFR, CSF1R and c-Kit inhibitor, is Gossamer’s only other R&D program to have advanced beyond Phase I.
Black Diamond Therapeutics Inc. (NASDAQ:BDTX) will prioritize clinical cancer therapy BDTX-1535 and preclinical oncology program BDTX-4933 after reducing its workforce by 30% and ending the development of BDTX-189 to treat cancers associated with EGFR and HER2 driver mutations. BDTX-1535 is an inhibitor of EGFR mutations in Phase I development to treat glioblastoma multiforme and non-small cell lung cancer. Black Diamond said on Monday that it hopes to submit an IND to FDA in the first half of 2023 for BDTX-4933, a brain-penetrant BRAF inhibitor...