Pliant Therapeutics (NASDAQ:PLRX) reported 12-week interim knowledge for its drug bexotegrast’s 320 mg dose group in a part 2a trial to deal with sufferers with a sort of lung illness known as idiopathic pulmonary fibrosis (IPF).

The study, dubbed, INTEGRIS-IPF, is evaluating bexotegrast (PLN-74809) at once-daily doses of 40 mg, 80 mg, 160 mg, 320 mg or placebo for 12 weeks in 119 sufferers with IPF — a situation in which the lungs grow to be scarred and respiratory turns into troublesome.

The 320 mg group enrolled 21 sufferers in the energetic arm and eight sufferers in the placebo group.

The firm stated the 320 mg group met its important and secondary objectives of exhibiting that bexotegrast was nicely tolerated over the 12-week therapy interval and displayed a good pharmacokinetic profile.

The trial’s efficacy objectives assessed modifications in compelled very important capability (FVC), Quantitative Lung Fibrosis (QLF) imaging and biomarkers.

The 320 mg dose confirmed a statistically important imply enhance in FVC from baseline in any respect timepoints, surpassing all decrease dose teams, and confirmed a robust therapy impact on FVC % predicted (FVCpp), QLF and profibrotic biomarkers versus placebo at 12 weeks, the corporate added.

Comparable to the decrease dose teams, ~80% of all enrolled sufferers had been on normal of care and had been equally distributed between nintedanib and pirfenidone, in response to the corporate.

Pliant famous {that a} sturdy dose-dependent therapy impact was seen in the bexotegrast 320 mg dose group, with and with out normal of care remedy.

Bexotegrast 320 mg was nicely tolerated and there have been no drug-related extreme or severe hostile occasions. The firm added that each one drug-related hostile occasions had been gentle or reasonable in severity.

Bexotegrast exhibited dose-proportional will increase in plasma concentrations, according to prior research, the corporate famous.

“Data from the INTEGRIS-IPF trial have far exceeded our expectations, supporting bexotegrast’s favorable security profile and demonstrating a statistically important therapy response on FVC at 320 mg,” stated Pliant’s Chief Medical Officer Éric Lefebvre.

The firm expects knowledge from the 320 mg group for at the very least 24 weeks of therapy in Q2 2023. Pliant is planning to begin a part 2b trial of bexotegrast in mid-2023.

PLRX +48.02% to $33.32 premarket Jan. 23