Bristol Myers reports phase‑3 trial shows 60 mg admilparant meets primary endpoint in IPF
Bristol Myers Squibb announced topline results from its phase‑3 ALOFT‑IPF trial. The 60 mg twice‑daily dose of admilparant significantly improved forced vital capacity versus placebo, while the 120 mg dose did not reach statistical significance. Both doses were well tolerated, with one death in the higher‑dose arm deemed unlikely drug‑related. The company will seek regulatory feedback and present detailed data at a future medical meeting.
Why it matters
The positive result for the 60 mg dose could open a new oral therapy for idiopathic pulmonary fibrosis, a disease with limited treatment options. BMS shares fell about 3 % in early trading as investors priced in the mixed outcome.
Key facts
- 1The trial enrolled about 1,255 adults aged 40 years or older and randomized them 1:1:1 to 60 mg admilparant, 120 mg admilparant, or placebo. ajmc.com
- 2The 60 mg dose met the primary endpoint of change in forced vital capacity at week 52 with statistical significance. ajmc.com
- 3The 120 mg dose did not achieve statistical significance for the primary endpoint. medicaldaily.com
- 4Both doses were well tolerated; discontinuations due to adverse events were low and similar to placebo. ajmc.com
- 5One death from multi‑organ failure with acute liver injury occurred in the 120 mg group and was judged unlikely related to the drug. medicaldaily.com
- 6BMS shares fell about 3 % in early trading following the announcement. medicaldaily.com
Summary written by AlphAI AI Desk from 2 of 2 sources. Not investment advice. Figures are as stated by the linked sources.