It is unclear why an independent data safety monitoring board recommended the suspension of Pliant’s Phase IIb/III BEACON-IPF study in idiopathic pulmonary fibrosis.
Safety issues have tripped up Pliant Therapeutics, which on Friday suspended dosing and enrollment in the Phase IIb/III BEACON-IPF study of its idiopathic pulmonary fibrosis drug candidate bexotegrast.
The voluntary pause follows a prespecified data review by an independent data safety monitoring board (DSMB), according to the biotech’s press announcement. Pliant did not reveal the specific reasons behind the board’s recommendation, noting that the company is also reviewing BEACON-IPF’s data “to understand the DSMB’s rationale for their recommendation.”
Patients already enrolled in the study will stay onboard and its blinding will be maintained “to preserve trial integrity,” Pliant noted in its release.
The news sent Pliant’s shares falling around 58% in aftermarket trading on Friday, according to SeekingAlpha.
Designed to be taken orally, bexotegrast is a small-molecule and dual-selective blocker of the αvβ6 and αvβ1 integrins, proteins that help convert the profibrotic cytokine TGF-β into its active form, according to Pliant’s website. αvβ6 and αvβ1 are both highly expressed in fibrotic tissue, but are rare under healthy circumstances.
By inhibiting αvβ6 and αvβ1, bexotegrast addresses an underlying disease pathway of idiopathic pulmonary fibrosis (IPF), potentially preventing the formation and growth of scar tissue. The candidate previously won the FDA’s Fast Track and Orphan Drug designations.
In May 2024, Pliant released topline Phase IIa data for bexotegrast demonstrating that treated patients saw a notable reduction in lung collagen, as measured by positron emission tomography scanning. Placebo counterparts, in contrast, experienced an increase in lung collagen. These findings, Pliant said at the time, suggest the “potential reversal of fibrosis” in bexotegrast-treated patients.
Bexotegrast also improved forced vital capacity and reduced cough severity versus placebo, according to Pliant’s readout.
Elsewhere in the IPF space is the $780 million licensing deal that Eli Lilly inked last month with Mediar Therapeutics. The back-heavy agreement—$99 million upfront and up to $687 million in milestones—will give the pharma access to MTX-463, an anti-WISP1 antibody with first-in-class potential for IPF. Preclinical data point to the potential of MTX-463 to lower fibrosis, according to Mediar, and the asset has recently completed a Phase I study.
A few months earlier, in November 2024, Insilico Medicine claimed victory in a Phase IIa IPF study, with its AI-developed asset ISM001-055 eliciting dose-dependent improvements in lung function as measured by forced vital capacity.
