Publication of positive data from phase 1b/IIa clinical study of efzofitimod for the treatment of pulmonary sarcoidosis in the journal CHEST
aTyr Pharma announced the publication in the journal CHEST of positive results from a Phase Ib/IIa randomized, double-blind, placebo-controlled clinical trial of its lead therapeutic candidate, ATYR 1923 (efzofitimod), in patients with pulmonary sarcoidosis, a major form of interstitial lung disease
The publication, entitled, “Efzofitimod for the treatment of pulmonary sarcoidosis,” is available on the journal’s website and at: https://doi.org/10.1016/j.chest.2022.10.037. The Phase Ib/IIa study was a randomized, double-blind, placebo-controlled, multiple-ascending dose clinical trial in 37 patients with pulmonary sarcoidosis
The trial consisted of three cohorts testing doses of 1.0 mg/kg, 3.0 mg/kg and 5.0 mg/kg of efzofitimod or placebo, dosed intravenously every month for six months. The primary objective of the study was to evaluate the safety, tolerability, immunogenicity and pharmacokinetic profile of multiple doses of efzofitimod compared to placebo. Secondary objectives included the potential steroid-sparing effects of efzofitimod, in addition to other exploratory assessments of efficacy, such as lung function.
The study demonstrated that efzofitimod was safe and well-tolerated at all doses and exhibited a consistent dose response on key efficacy endpoints and improvements compared to placebo, including measures of steroid reduction, lung function, sarcoidosis symptom measures and inflammatory biomarkers.