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gentle treatment (Nasdaq: PLRX) said that the bexotegrast 320 mg dose met the primary and secondary goals of a Phase 2a trial in patients with some form of lung disease.
The company reports 24 weeks of data from the 320-mg dose group of the study, called INTEGRIS-IPF, in patients with Idiopathic pulmonary fibrosis (IPF) – 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. Compared to the low-dose groups, about 80% of the patients enrolled were at standard of care and were evenly distributed between nintedanib, which is sold as Ofev by Boehringer Ingelheim, and pirfenidone, which is marketed as Pirespa.
The main goal of the trial was the safety and tolerability of bexotegrast (PLN-74809) and the drug showed that it was well tolerated for up to 40 weeks of treatment without any serious drug-related adverse events, according to the company.
Pliant added that at week 24, combining bexotegrast with standard of care reduced the forced vital capacity (FVC) decline by 80% compared to standard of care alone.
FVC is the maximum amount of air a person can forcefully exhale from the lungs after a full inhalation. It is a measure of the function of the respiratory muscles.
The company noted that at Week 24, 50% of patients treated with pixotegrast experienced an increase in forced vital capacity from the time they started treatment, compared to 0% in the placebo group. In addition, among patients on the drug who experienced an increase in FVC from baseline at Week 12, 89% maintained an increase in FVC at Week 24.
Fibrosis stabilization was observed in those who received bexotegrast, while the placebo group showed progression of fibrosis at weeks 12 and 24.
Pliant added that a decrease in patient-reported cough intensity was seen in those receiving bexotegrast, compared with placebo-treated patients’ cough intensity that worsened over time.
“These data build on our previously reported results and highlight an appropriate long-term safety profile and provide further evidence of lasting improvement in the FVC, the scoring endpoint of IPF,” said Eric Lefebvre, Pliant’s chief medical officer.
The company plans to begin a 52-week Phase 2b trial called BEACON-IPF of bexotegrast at a dose of 160 mg and 320 mg in about 270 patients with IPF, in mid-2023.
PLRX +6.19% to $30 on May 1