Bristol Myers Squibb (BMS) has seen success in two pivotal trials, one in idiopathic pulmonary fibrosis (IPF) and one in patients with gastroenteropancreatic neuroendocrine tumours (GEP-NETs).
In IPF, a pivotal trial of BMS’s potential first-in-class, orally administered, potent and selective lysophosphatidic acid receptor 1 (LPA1) antagonist, admilparant, met its primary endpoint.
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In the Phase III ALOFT-IPF trial (NCT06003426), BMS investigated two doses – 60mg and 120mg of admilparant, with the lower dose demonstrating a statistically significant improvement compared to placebo in absolute change in forced vital capacity (FVC) after 52 weeks of treatment.
While the lower dose was statistically significant, BMS added that although the 120mg dose did slow the decline of FVC, the data was not statistically significant.
Admilparant demonstrated a well-tolerated safety profile across both doses, and discontinuations due to adverse events (AEs) were low and similar to placebo. There were no liver concerns mentioned by BMS, an AE which had previously led to protocol amendments.
Dr Fernando Martinez, chair of the ALOFT programme clinical steering committee, and professor of medicine at UMass Chan Medical School, said: “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. 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 company will complete a comprehensive evaluation of the Phase III 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.
BMS is also evaluating admilparant in the Phase III ALOFT-PPF trial (NCT06025578) in progressive pulmonary fibrosis (PPF), with topline results anticipated in early 2027.
According to GlobalData analysis, the global IPF market will experience growth during the forecast period, with sales across the seven major markets (7MM: US, France, Germany, Italy, Spain, UK and Japan) expected to increase from $2.8bn to $6bn at a compound annual growth rate (CAGR) of 8.2%.
Major drivers of this will be the launches of several pipeline agents, the most notable being admilparant, as well as Boehringer Ingelheim’s Jascayd (nerandomilast) and United Therapeutics’ Tyvaso (treprostinil).
Boehringer Ingelheim is already well established in the IPF field with its anti-fibrotic drug Ofev (nintedanib), which gained approval in the US on 15 October 2014. Jascayd has since gained US Food and Drug Administration (FDA) approval in December 2025, with the company hoping it will fill the void left by Ofev, which lost major patents in April 2026.
GEP-NET trial also succeeds
The company also posted a win in the Phase III ACTION-1 trial (NCT05477576), with RYZ101 (225Ac-DOTATATE) showing a statistically significant and clinically meaningful improvement in progression-free survival (PFS) in patients with GEP-NETs who have progressed following Lutetium-177 (Lu177)-based therapy.
The company added that safety results for the radiopharmaceutical therapy remained consistent with its known safety profile. RYZ101, which is being developed by BMS subsidiary RayzeBio, combines DOTATATE with the alpha-emitting radioisotope Actinium-225 (Ac-225). BMS acquired RayzeBio for around $4.1bn in 2024.
Dr Amreen Husain, CMO of RayzeBio, said: “These are the first results from a Phase III trial of an alpha-isotope-based targeted RPT (225Ac) in any indication, and we are moving with urgency to bring these data to the FDA and, ultimately, provide a novel option for patients.”
The FDA granted RYZ101 Orphan Drug Designation for the treatment of GEP-NETs in August 2026, with RayzeBio adding that the designation and the interim analysis support continued development efforts and plans to engage with the FDA to discuss next steps towards a regulatory submission.
