Respira Therapeutics has announced that United Therapeutics will end its collaboration with the company and will return all rights to Respira’s RT234 vardenafil DPI, which is in Phase 2 development for the relief of symptoms of pulmonary arterial hypertension (PAH). The companies had announced the licensing deal and an investment by United Therapeutics in Respira in April 2017.
According to Respira, United Therapeutics made the decision “based on a strategic prioritization of assets within United Therapeutics’ product development portfolio.” The company also said that United Therapeutics would keep its equity stake in Respira.
Respira President and CEO Bob Curtis commented, “We are grateful for the investment United Therapeutics has made in Respira during the early stage of RT234’s development. The positive data from our non-clinical and Phase 1 studies in healthy volunteers represent significant milestones for the development of RT234 as the first as-needed therapy for symptomatic relief in PAH patients. We are proud of the progress the Respira team has made to advance RT234 from a product concept into Phase 2 development in a very short time. As a result, we are well positioned and excited to move RT234 through Phase 2 clinical trials for pulmonary arterial hypertension and explore additional product indications to maximize the value of our RT234 program.”
RT234 has received orphan drug designation from the FDA, and the company has said that it plans to seek approval for the drug via the FDA’s 505(b)(2) pathway.
Read the Respira Therapeutics press release.