Respivant Sciences has announced dosing of the first patient in the Phase 2b SCENIC trial of its RVT-1601 cromolyn sodium inhalation solution for the treatment of cough in idiopathic pulmonary fibrosis (IPF) patients.
Respivant was spun off from Roivant in September 2018 specifically to develop RVT-1601. Roivant acquired the cromolyn sodium inhalation solution, formerly known as PA101 from Patara, which in 2016 announced results from a Phase 2a trial in 24 patients with IPF cough, demonstrated that RVT-1601 reduced cough frequency by a percent that was both statistically significant and clinically meaningful.
The SCENIC study will compare 3 doses of nebulized RVT-1601 to placebo and expects to enroll 180 IPF patients. The primary endpoint is change in 24-hour cough frequency after 12 weeks of dosing versus placebo, with secondary endpoints consisting of several patient reported outcomes. A 12-week open-label treatment period will follow the double-blind treatment period.
Respivant Sciences CEO Bill Gerhart said, “The majority of people with IPF suffer from a persistent, hard-to-treat cough that can be physically and psychologically debilitating. The need for new medicines that can improve the quality of life of IPF patients is as important to patients as the effort to slow or stop progression of the underlying disease. We’re hopeful the results from our SCENIC trial will confirm and build upon the positive results from our previously conducted Phase 2a clinical trial.”
Read the Respivant Sciences press release.
