On Monday, Pliant Therapeutics Inc. PLRX introduced that it might discontinue the BEACON-IPF Part 2b trial, which evaluated bexotegrast in sufferers with idiopathic pulmonary fibrosis (IPF).
The transfer follows a prespecified information evaluation and suggestion by the trial’s impartial Information Security Monitoring Board (DSMB) and a secondary evaluation and suggestion by an outdoor professional panel.
Whereas an imbalance in unadjudicated IPF-related hostile occasions between the remedy and placebo teams led to the discontinuation of the trial, early proof of efficacy on the pressured important capability (FVC) endpoint was additionally noticed.
Additionally Learn: Pliant Therapeutics Pauses Lead Product Mid-Stage Trial In Sufferers With Stiff Lung Tissues
The imply publicity period in BEACON-IPF was roughly 17 weeks.
General, the proportion of IPF-related hostile occasions in each dose teams was comparable (roughly 10%). The imbalance between energetic and placebo seems to have been pushed by a low (under 3%) IPF-related hostile occasion fee within the placebo group.
Within the Part 2a INTEGRIS-IPF trial, IPF-related hostile occasions have been comparable in bexotegrast-treated (7%) throughout all doses and placebo-treated (10%) members.
The corporate plans to research the whole information from the BEACON-IPF trial and consider the subsequent steps in growing bexotegrast.
As soon as the total evaluation is accomplished, which ought to present a greater understanding of the benefit-risk profile and therapeutic window of bexotegrast, the corporate will think about further dose-ranging Part 2b research with decrease doses in pulmonary fibrosis and probably different non-respiratory indications, together with liver illnesses.
Pliant is presently enrolling the fourth of 5 deliberate dose cohorts in a Part 1 open label dose-escalation trial of PLN-101095 as monotherapy and together with pembrolizumab in sufferers with strong tumors which might be proof against immune checkpoint inhibitors.
Interim information from the primary three cohorts is anticipated within the first quarter of 2025.
Worth Motion: PLRX inventory is down 51% at $1.69 on the final test Monday.
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