Bellerophon Therapeutics, Inc. announced that results from Cohort 1 of the iNO-PF Phase II/III Study will be published in the August 2020 edition of the peer-reviewed CHEST Journal, the official publication of the American College of Chest Physicians, and the Chief Medical Officer of Bellerophon, Hunter Gillies, M.D., will participate in a webinar with study investigators to discuss clinical implications of the data.
The iNO-PF study evaluated safety and efficacy in patients at risk for pulmonary hypertension associated with pulmonary fibrosis who were treated with the proprietary INOpulse inhaled nitric oxide therapy at a dose of 30 mcg/kg IBW/hr (iNO30). The results from this first cohort established the safety of the iNO30 dose and confirmed the potential for INOpulse to provide clinically meaningful benefits in levels of daily activity in this patient population.
Dr. Gillies will be joined by study authors, Steven D. Nathan, M.D., F.C.C.P., Medical Director of the Advanced Lung Disease and Lung Transplant Program at Inova Fairfax Hospital and Lisa Lancaster, M.D., Professor of Medicine and Director of the Interstitial Lung Disease Program at Vanderbilt University Medical Center. The webinar will be hosted by the CHEST Journal Club and available for live viewing and a Q&A session at https://bit.ly/38WOzlY on Thursday, July 16th, from 4:00-5:00 pm EDT.
Cohort 1 of the iNO-PF Study was designed as a Phase IIb study to explore several endpoints and included 41 patients that were randomized 1:1 to receive either placebo or iNO30. Following eight weeks of therapy, patients treated with iNO30 demonstrated clinically and statistically significant benefits in moderate to vigorous physical activity (p=0.04) and overall activity (p=0.05). The benefits in activity levels were supported by improvements in oxygen saturation and NT-proBNP, a peptide marker of right ventricular failure, with higher levels indicative of disease worsening. The iNO30 dose was safe and well-tolerated. More recently, the Company completed Cohort 2, which assessed a higher iNO45 (45 mcg/kg IBW/hr) dose and verified the results demonstrated in Cohort 1 and is preparing to initiate its pivotal Phase III Cohort in a 300 patient placebo-controlled trial..
” As the first randomized, placebo-controlled study to assess the therapeutic benefits of nitric oxide in patients with pulmonary fibrosis, I’m pleased to participate in the CHEST Journal Club event with the lead investigators of the iNO-PF Study to review how treatment with INOpulse enabled patients to achieve benefits in daily physical activity for the first time,” said Dr. Gillies. “These patients have severe functional impairment and a limited life expectancy, and often suffer from significant right ventricular dysfunction secondary to pulmonary vascular disease that limits their ability to perform even the most basic daily tasks. The Cohort 1 results are especially exciting because they represent the first time that such benefits have been observed using daily physical activity as a meaningful patient-centric endpoint, which we look forward to discussing further during the webinar.”.