Bellerophon Therapeutics Announces Publication of Cohort 1 of iNO-PF Phase 2/3 Study in the CHEST Journal and Participation in Webinar to Discuss Clinical Results
Bellerophon Therapeutics (BLPH) announced positive results from Cohort 1 of the iNO-PF Phase 2/3 Study, indicating that patients treated with INOpulse® showed improved physical activity compared to placebo. The findings, set to be published in the August 2020 edition of the CHEST Journal, confirm the safety and efficacy of the iNO30 dosage for patients at risk of pulmonary hypertension associated with pulmonary fibrosis. Notably, treated patients demonstrated significant increases in moderate to vigorous physical activity (p=0.04) and overall activity (p=0.05). The next Phase 3 trial is being prepared.
- Cohort 1 results confirm safety of iNO30 dosage for pulmonary fibrosis patients.
- Patients demonstrated significant improvements in physical activity levels.
- Next pivotal Phase 3 trial is in preparation for 300 patient placebo-controlled study.
- None.
Patients Treated with INOpulse® Demonstrated Improved Physical Activity Compared to Placebo
Live Webinar with Study Investigators on Thursday, July 16th, from 4:00-5:00 pm EDT
WARREN, N.J., July 15, 2020 (GLOBE NEWSWIRE) -- Bellerophon Therapeutics, Inc. (Nasdaq: BLPH), a clinical-stage biotherapeutics company focused on developing treatments for cardiopulmonary and infectious diseases, today announced that results from Cohort 1 of the iNO-PF Phase 2/3 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.
“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.”
Cohort 1 of the iNO-PF Study was designed as a Phase 2b 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 3 Cohort in a 300 patient placebo-controlled trial.
About Bellerophon
Bellerophon Therapeutics is a clinical-stage biotherapeutics company focused on developing innovative therapies that address significant unmet medical needs in the treatment of cardiopulmonary and infectious diseases. The Company is currently developing multiple product candidates under its INOpulse® program, a proprietary pulsatile nitric oxide delivery system. For more information, please visit www.bellerophon.com.
Forward-looking Statements
Any statements in this press release about Bellerophon’s future expectations, plans and prospects, including statements about the clinical development of its product candidates, regulatory actions with respect to the Company’s clinical trials and expectations regarding the sufficiency of the Company’s cash balance to fund clinical trials, operating expenses and capital expenditures, and other statements containing the words “anticipate,” “believe,” “continue,” “contemplate,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would,” and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the uncertainties inherent in the initiation of future clinical trials, availability and timing of data from ongoing and future clinical trials and the results of such trials, whether preliminary or interim results from a clinical trial will be predictive of the final results of that trial or whether results of early clinical trials will be indicative of the results of later clinical trials, expectations for regulatory approvals, the FDA’s substantial discretion in the approval process, availability of funding sufficient for our foreseeable and unforeseeable operating expenses and capital expenditure requirements and other factors discussed in the “Risk Factors” section of the Company’s most recent Annual Report on Form 10-K and in subsequent filings with the Securities and Exchange Commission. In addition, any forward-looking statements included in this press release represent Bellerophon’s views only as of the date of this release and should not be relied upon as representing the Company’s views as of any subsequent date. The Company specifically disclaims any obligation to update any forward-looking statements included in this press release.
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