Respira Therapeutics has announced the initiation of a Phase 2b trial of its RT234 dry powder vardenafil in patients with pulmonary arterial hypertension (PAH). The open label study will include two cohorts, with the first receiving a single 0.5 mg dose of RT234 via the Axial Oscillating Sphere inhaler and the second getting a 1 mg dose (2 x 0.5 mg). United Therapeutics was previously partnered with Respira on development of RT234 for PAH but returned the rights to the DPI in 2019.
Respira President and Chief Medical Officer Carol Satler commented, “The initiation of this clinical trial represents an important milestone for Respira and is a critical next step in potentially offering patients with PAH an acute treatment to manage their shortness of breath, which prevents them from performing normal daily duties. People suffering from this debilitating and serious condition who are being treated with maintenance therapies still experience episodes of shortness of breath, tiredness and inability to exercise, and there are currently no rapid onset therapies available for ‘as needed’ use to mitigate these episodes.”
Read the Respira Therapeutics press release