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First Patient Dosed with Pulmonary Arterial Hypertension

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Respira Therapeutics, Inc. announced today that the first patient in the United States has been dosed in the multicenter trial of its lead product candidate, RT234-PAH (vardenafil administered as a dry powder inhaled treatment). The VIPAH-PRN 2b trial (Vardenafil Inhaled for Pulmonary Arterial Hypertension – PRN) will consist of two sequential cohorts receiving RT234 as single doses administered via an Axial Oscillating Sphere dry powder inhaler. The study is designed to evaluate the safety and preliminary efficacy of RT234 to acutely improve episodic symptoms and exercise capacity in people being treated for pulmonary arterial hypertension (PAH) with New York Heart Association (NYHA) Functional Class II-III symptoms.     

“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,” said Carol Satler, PhD, M.D., President and Chief Medical Officer of Respira. “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.”

“Enabling PAH patients to be more active is key to their physical and mental health,” said Raymond L. Benza, MD, Director of the Division of Cardiovascular Medicine at The Ohio State University Wexner Medical Center. “Now with the study of RT234, we are examining our ability to boost physical activity when a patient needs it. It’s potentially a great step forward in our battle with this disease.”

The VIPAH-PRN 2b trial (RT234-PAH-CL202) is a dose-escalation study to evaluate acute changes in symptoms post dosing of RT234 in subjects with PAH. It is hypothesized that inhaled RT234 (vardenafil inhalation powder) may provide a therapeutic benefit for acute use in patients with World Health Organization (WHO) Group 1 Pulmonary Hypertension (PH) (Pulmonary Arterial Hypertension [PAH]) to improve exercise capacity and performance in activities of daily living, as well as reduce exertional symptoms (e.g., dyspnea) and their deleterious impacts on quality of life.

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Editor in chief for eTurboNew is Linda Hohnholz. She is based in the eTN HQ in Honolulu, Hawaii.

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