Respira Therapeutics Regains North America Rights from United Therapeutics to Phase 2 Inhaled Drug-Device Product, RT234, for Pulmonary Hypertension Indications

ALBUQUERQUE, N.M., Oct. 10, 2019 /PRNewswire/ -- Respira Therapeutics, a clinical-stage specialty pharmaceutical company developing next-generation cardiopulmonary disease-targeted inhalation products, has regained full worldwide research, development, and licensing rights to the company's novel inhaled drug-device combination product, RT234, following a decision by United Therapeutics Corporation UTHR to conclude its collaboration with Respira based on a strategic prioritization of assets within United Therapeutics' product development portfolio. RT234 recently concluded successful Phase 1 clinical studies and is currently in Phase 2 studies for a pulmonary arterial hypertension (PAH) indication.

Respira and United Therapeutics entered into a strategic collaboration in April 2017 for the co-development and exclusive license of RT234 for pulmonary hypertension indications in North America markets. The research and development costs of this drug-device candidate were supported by United Therapeutics. As a result of the conclusion of the collaboration, Respira has no further obligation to United Therapeutics regarding the RT234 program, and United Therapeutics has no future development funding obligations. All development, commercialization, and licensing rights to the RT234 program, including intellectual property rights and all program information generated under the collaboration, have reverted to Respira. United Therapeutics will retain its minority preferred equity stake in Respira.

"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," said Bob Curtis, President and CEO of Respira. "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."

About RT234
Respira's lead drug-device product candidate, RT234, is a first-in-class inhaled therapy intended for as-needed (PRN) use to improve exercise tolerance and provide acute relief from breathlessness and fatigue, the most commonly reported symptoms in WHO Group 1 pulmonary arterial hypertension (PAH) patients. This contrasts with all current PAH treatments, which are taken according to a specific treatment regimen and monitored for chronic improvements in outcome measures. RT234 demonstrated significant safety margins in preclinical testing and was well tolerated in Phase 1 clinical studies, with PK consistent with expectations for a PRN medication. Respira has received FDA Orphan Drug designation for the active ingredient in RT234 (vardenafil, a potent vasodilator that is FDA-approved in an oral form for a non-PAH indication) for the treatment of PAH and is currently in Phase 2 clinical testing for this indication. Respira is pursuing the 505(b)(2) FDA approval pathway, which will allow the company to reference previous findings of safety and efficacy of vardenafil to supplement the company's safety and efficacy data on its proprietary vardenafil inhalation powder drug formulation. Respira intends to pursue additional indications for RT234 in other WHO pulmonary hypertension patient groups.

About Respira Therapeutics
Respira Therapeutics is a clinical-stage specialty pharmaceutical company developing next-generation cardiopulmonary disease-targeted inhalation products that enhance drug delivery to the lung periphery. Respira's approach combines state-of-the-art proprietary inhaled drug formulation and dry-powder inhaler device technologies, designed to improve lung targeting and dose consistency while maximizing dose delivery to the small airways. Respira's first product candidate, RT234, has received FDA Orphan Drug Designation for Pulmonary Arterial Hypertension (PAH) and is in Phase 2 clinical trials for as-needed (PRN) use in PAH patients. Learn more at www.respiratherapeutics.com.

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SOURCE Respira Therapeutics