Bristol Myers Squibb has scored a key clinical trial win for its experimental lung disease drug admilparant, with the treatment meeting the primary endpoint in a pivotal Phase 3 trial at the lower of two doses tested in patients with idiopathic pulmonary fibrosis (IPF).

 

The ALOFT-IPF trial found that admilparant, an oral investigational drug designed to block the lysophosphatidic acid receptor 1 (LPA1) pathway, significantly improved the change in forced vital capacity (FVC) from baseline at Week 52 compared with placebo at the 60 mg twice-daily dose.

 

However, the 120 mg twice-daily dose slowed the decline in FVC but failed to achieve statistical significance, leaving the lower dose as the one that met the trial’s primary goal.

 

IPF is a progressive lung disease marked by irreversible scarring, declining lung function and unpredictable disease progression. The condition can severely affect patients’ daily lives, underscoring the need for treatments that can slow deterioration while remaining tolerable over the long term.

 

Bristol Myers Squibb said admilparant demonstrated a well-tolerated safety profile at both doses. Discontinuations due to adverse events were low and comparable to placebo in both treatment groups.

 

“Taken together, these topline data reinforce the profile of admilparant as a promising, clinically meaningful investigational therapy for IPF – one that reflects the innovation of targeting the LPA1 pathway as a first-in-class approach,” said Cristian Massacesi, executive vice president, chief medical officer and head of development, Bristol Myers Squibb. 

 

“We also look forward to sharing the topline results from the ALOFT-PPF trial early next year, as we continue working to improve outcomes for patients with pulmonary fibrosis.”

 

The company is also awaiting results from ALOFT-PPF, a separate trial evaluating admilparant in patients with progressive pulmonary fibrosis. Topline results are expected early next year, potentially providing further insight into the drug’s prospects across pulmonary fibrosis conditions.

 

“IPF remains one of the most complex and challenging lung diseases to treat, with unpredictable progression, irreversible scarring and a profound impact on patients’ daily lives,” said Fernando Martinez, chair of the ALOFT program clinical steering committee and the Joseph D. Early Chair in Biomedical Research, interim chair and professor of medicine at UMass Chan Medical School. 

 

“These admilparant results represent an important advancement as there remains a need for therapies that are both effective and tolerable for patients living with IPF.”

 

The Phase 3 ALOFT-IPF trial evaluated admilparant at 60 mg and 120 mg, administered twice daily for at least 52 weeks, against placebo, with participants assigned in a 1:1:1 ratio.

 

While the results at the lower dose mark a clinical milestone for Bristol Myers Squibb, the findings are topline data. Further details will be needed to assess the magnitude of the treatment effect, the broader safety profile and the drug’s potential role in treating IPF.