Pliant Therapeutics has pumped the breaks on a midstage trial of its lead lung disease drug on the advice of its safety committee.
The South San Francisco biotech has been evaluating 160-mg and 320-mg doses of bexotegrast, a dual selective inhibitor of αvß6 and αvß1 integrins, in the phase 2b/3 BEACON-IPF trial of patients with idiopathic pulmonary fibrosis (IPF). The 52-week, placebo-controlled multinational study had been on track to complete enrolment of the planned 360 patients in the first quarter of 2025, with a readout penciled in for mid-2026.
But Pliant announced in a postmarket release Feb. 7 that the company has voluntarily paused enrollment and dosing in BEACON-IPF on the recommendation of the trial’s independent data safety monitoring board (DSMB). The advice followed a prespecified review of the study’s data, Pliant said.
The biotech gave no hint as to the specific concerns that were raised from the data, only adding that it would now review the data “to understand the DSMB’s rationale for their recommendation.”
“The company has informed BEACON-IPF clinical trial investigators and is in the process of informing global regulatory authorities,” Pliant added.
Pliant told Fierce Biotech it could not provide additional information as the DSMB has not yet shared the rationale for the hold.
The early signs from the trial seemed good, with Pliant CEO Bernard Coulie, M.D., Ph.D., reporting in November that “the continued strong execution” of BEACON-IPF had been “a highlight to this quarter’s progress.”
“We are pleased with the interest from the global physician and patient communities in participating in BEACON-IPF and look forward to sharing data in mid-2026,” Coulie added in that third-quarter financial update.
Last year, Pliant reported phase 2 data from a different trial that showed that a 320-mg dose of bexotegrast was safe and effective at slowing the progression of primary sclerosing cholangitis, a liver condition where bile ducts are inflamed and scarred.
Pliant also has another therapy in the clinic in the form of PLN-101095. The alphaVbeta1/8 inhibitor is undergoing a phase 1 study in solid tumors.