Bristol Myers Squibb reports admilparant trial success as higher dose misses
The 60 mg dose met ALOFT-IPF's lung-function endpoint, but the topline release gives no effect size or filing date.
Adrian Kessler
A 60 mg dose met the Phase 3 lung-function endpoint as Bristol Myers Squibb NYSEBMY reported admilparant results on Monday. The 120 mg dose slowed lung-function decline but failed to reach statistical significance against placebo.
The randomized, double-blind ALOFT-IPF trial enrolled approximately 1,255 adults with idiopathic pulmonary fibrosis, a disease that scars the lungs. Participants received either dose or placebo twice daily for at least 52 weeks, with equal allocation among the three groups. The company plans regulatory submissions and expects a companion trial's results in early 2027.
Bristol Myers Squibb is a large drugmaker developing and selling medicines in the United States and internationally.
Shares closed at US$59.12 on the NYSE at 4:00 p.m. EDT on Oct. 9, according to the NYSEBMY quote. That close preceded Monday's readout and cannot show a reaction to it.
One Dose Met the Statistical Threshold
The primary measure was absolute change in forced vital capacity from baseline to week 52, rather than a survival endpoint. The Oct. 12 release gives no lung-function changes for the individual arms, treatment difference, p value or confidence interval.
Those omissions prevent assessment of the size and precision of the benefit at the successful dose. Bristol Myers calls the findings potentially clinically meaningful, but does not explain why the higher dose failed to reach statistical significance.
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The company described low adverse-event discontinuations similar to placebo at both doses, but gave no rates or detailed adverse-event tables. Its safety characterization accompanies a topline announcement, with detailed results planned for a future medical meeting.
"The company will complete a comprehensive evaluation of the Phase 3 ALOFT-IPF trial data and engage with health authorities to support planned regulatory submissions, with detailed results to be presented at a future medical meeting," Bristol Myers said in its release.
The Oct. 12 announcement does not describe FDA feedback on the design or say that a submission has been filed. It names neither a filing date nor a date for the detailed presentation.
The lung-disease readout adds another late-stage update after Bristol Myers' Zenbexus myeloma result, which Mugglehead covered on Oct. 10.
Read more: Bristol Myers Squibb reports 51 per cent lower progression or death risk with Zenbexus regimen
Other Fibrosis Programmes Measure Lung Function
In its Oct. 12 release, Bristol Myers estimates that approximately 1.4 million people globally live with idiopathic pulmonary fibrosis. Admilparant targets the LPA1 pathway, which the company describes as involved in the development of lung fibrosis.
Contineum Therapeutics, Inc. NASDAQCTNM said on March 5 that it had begun dosing in its Phase 2 PROPEL-IPF trial of PIPE-791, another oral LPA1 antagonist. That protocol measures forced vital capacity over 26 weeks and planned approximately 324 participants.
United Therapeutics Corporation NASDAQUTHR reported a positive TETON-1 result on March 30 for nebulized Tyvaso. The treatment difference against placebo was 130.1 millilitres at week 52. These trials did not compare their medicines directly with admilparant.
Bristol Myers reported US$13.0 billion of revenue for the quarter ended June 30 in its July 30 financial release. The Oct. 12 admilparant announcement supplied no programme-specific cash-runway estimate.
The next dated programme catalyst is ALOFT-PPF's readout in early 2027. That fully enrolled trial includes approximately 1,057 adults and will test whether admilparant preserves lung function in non-idiopathic progressive pulmonary fibrosis.
