First clinical trial to evaluate the safety & efficacy of RT234 on exercise parameters assessed by Cardiopulmonary Exercise Testing (CPET)
PALO ALTO, Calif., April 5, 2022 /PRNewswire/ — Respira Therapeutics, Inc. a clinical-stage company developing inhaled therapeutics for cardiopulmonary diseases that improve patient outcomes through enhanced drug targeting to the small airways of the lung, 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. For more information about the trial, visit clinicaltrials.gov or https://www.vipah-prntrials.com/
About RT234
Respira’s lead drug-device product candidate, RT234-PAH, is an investigational, first-in-class inhaled therapy intended for as needed 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 generally well tolerated in Phase 1 clinical studies, with pharmacokinetic properties consistent with expectations for an acute medication. Respira has received FDA Orphan Drug designation for the active ingredient in RT234, vardenafil, a potent PDE5i vasodilator that is FDA-approved in an oral form for a non-PAH indication. RT234 is currently in Phase 2 clinical testing for the PAH 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 company developing inhaled therapeutics for cardiopulmonary diseases that improve patient outcomes through enhanced drug targeting to the small airways of the lung. Respira’s approach combines state-of-the-art, proprietary inhaled drug formulations with dry powder inhaler device technologies to create novel therapeutic products designed to improve dose consistency while enhancing delivery to the lung periphery. Respira’s lead product candidate, RT234-PAH, has received FDA Orphan Drug Designation for Pulmonary Arterial Hypertension and is in Phase 2 clinical trials as a first-in-class inhaled therapeutic for as-needed use to provide acute relief for the most commonly reported symptoms in PAH patients. Learn more at https://respiratherapeutics.com/ .
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SOURCE Respira Therapeutics, Inc.
