BMS eyes filings for idiopathic pulmonary fibrosis drug

Bristol Myers Squibb has reported phase 3 results with a new type of drug for idiopathic pulmonary fibrosis (IPF) that could open the door to regulatory filings.

Topline data from the ALOFT-IPF study of LPA1 antagonist admilparant (formerly BMS-986278) shows that the oral therapy achieved a statistically significant improvement in a key measure of lung function – the absolute change in forced vital capacity (FVC) – compared with placebo.

The study compared two doses of admilparant (60 mg and 120 mg twice daily) to placebo over 52 weeks in adults with IPF, a progressive and life-threatening interstitial lung disease (ILD). IPF is the most common type of ILD, affecting around 1.4 million people worldwide, with a median survival time of just three to five years after diagnosis.

At the 60 mg dose, there was a statistically significant improvement in the absolute change from baseline in FVC compared to placebo after a year, with a "favourable safety and tolerability profile" for both doses, according to BMS.

That said, the 120 mg dose was unable to show a statistically significant improvement over the control group – a lack of a dose-response relationship that may raise some eyebrows. There was no difference between the two doses and placebo in discontinuations, suggesting tolerability was not skewing the result for the 120 mg arm.

In a statement, BMS said the totality of the data "reinforce[s] 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."

The company said it is analysing the data from ALOFT-IPF with a view to filing for approval of the drug with international regulatory agencies in the coming months.

BMS has been investigating LPA1 as a drug target for fibrotic diseases for several years, and now has an opportunity to bring the first drug in the class to market.

It is also running a second phase 3 trial (ALOFT-PPF) in progressive pulmonary fibrosis (PPF). In PPF, the pulmonary fibrosis results from an identifiable cause, such as environmental exposure to dust or chemicals, or as a complication of another disease, such as rheumatoid arthritis or scleroderma. Results from the ALOFT-PPF study are due next year.

While PPF is less common than IPF, it has a similar three- to five-year median survival time, with only around 45% of patients still alive five years after diagnosis.

For years, pulmonary fibrosis treatment relied on two medicines – Boehringer Ingelheim's kinase inhibitor Ofev (nintedanib) and Roche's rival Esbriet (pirfenidone) – which have limited efficacy in slowing down progression whilst also being associated with challenging side effects.

Ofev made €3.8 billion in sales for the German pharma group last year, while Esbriet was also a €1 billion-plus drug at its peak, but has lost patent protection. Last year, Boehringer secured approval for a new IPF drug, PDE4B inhibitor Jascayd (nerandomilast), which ended a decade-long drought in new therapies.