Pliant Therapeutics (NASDAQ:PLRX) said bexotegrast 320-mg dose met the main and secondary goals of a phase 2a trial in patients with a type of lung disease.
The company reported 24-week data from the 320 mg dose group of the study, dubbed INTEGRIS-IPF, in patients with idiopathic pulmonary fibrosis (IPF) — is a condition in which the lungs become scarred and breathing becomes difficult.
The 320-mg group enrolled 21 patients in the active group and 8 patients in the placebo group. Comparable to the lower dose groups, about 80% of enrolled patients were on standard of care and were equally distributed between nintedanib, sold as Ofev by Boehringer Ingelheim, and pirfenidone, marketed as Pirespa.
The main goal of the trial was safety and tolerability of bexotegrast (PLN-74809) and the medicine showed that it was well tolerated up to 40 weeks of therapy with no drug-related serious adverse events, according to the company.
Pliant added that at week-24, a combination of bexotegrast with standard of care reduced forced vital capacity (FVC) decline by 80% relative to standard of care alone
FVC is the maximum amount of air a person can forcibly exhale from the lungs after fully inhaling. It is a measurement of respiratory muscle function.
The company noted that at week-24, 50% of bexotegrast-treated patients experienced an increase in FVC from the time treatment started, compared to 0% in the placebo group. In addition, among the patients on the drug who experienced an increase in FVC from baseline at week 12, 89% maintained an increase in FVC at week-24.
Stabilization of fibrosis was seen in those receiving bexotegrast, while the placebo group showed progression of fibrosis at Weeks-12 and 24.
Pliant added that reduction in patient-reported cough severity was seen in those receiving bexotegrast, compared to placebo-treated patients’ cough severity worsening over time.
“These data build on our previously reported results and highlight a favorable long-term safety profile and provide further evidence of a durable improvement in FVC, the registrational endpoint in IPF,” said Pliant’s Chief Medical Officer Éric Lefebvre.
The company is planning to start a 52-week phase 2b trial called BEACON-IPF of bexotegrast at 160 mg and 320 mg doses in about 270 patients with IPF, in mid-2023.
PLRX +6.19% to $30 premarket May 1