Pliant Therapeutics unveiled more efficacy data from a small mid-stage trial of its lead candidate in idiopathic pulmonary fibrosis, which shows that its oral drug could potentially reverse fibrosis.
The Phase 2a trial had a primary endpoint of change in type 1 collagen in the lung, as measured by standardized uptake value (SUV) of a certain radiotracer that binds to this form of collagen. In 10 evaluated patients, bexotegrast led to a mean 0.015 reduction from baseline in the top quartile SUV, versus a mean 0.074 increase for placebo, according to a company release.
Type 1 collagen is the main form of collagen produced by the lungs in IPF.
Tuesday’s results add on to a previous data readout showing that about half of 21 patients who were given bexotegrast had improved lung function. The dual integrin inhibitor is now in a larger 360-patient Phase 2b/3 test that started earlier this year. Integrins – notably αvβ6 and αvβ1 integrins – play a role in a chain of steps that lead to IPF.
The new data “indicates reduced total lung collagen in the treated group, suggesting potential reversal of fibrosis,” Pliant said in the release. Bexotegrast was also linked with reductions in cough severity at all timepoints versus placebo.
Pliant shares $PLRX were up 6% premarket Tuesday to more than $14 before settling at around $13.75 at market open.
The 12-week Phase 2a INTEGRIS-IPF trial recruited a total of 29 patients with IPF. On May 1, the biotech said that in an exploratory endpoint, 50% of treated patients had an increase from baseline in forced vital capacity at 24 weeks, while no placebo patients had a change.