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Bellerophon Provides Update on INOpulse Phase 2b Clinical Program for Treatment of Pulmonary Hypertension Associated with Interstitial Lung Disease
Oct. 09, 2018 09:05AM PST
Biotech InvestingBellerophon Therapeutics (Nasdaq:BLPH) a clinical-stage biotherapeutics company, today provided an update on the Company’s ongoing Phase 2b randomized, double-blind, placebo-controlled clinical study (iNO-PF) evaluating INOpulse in patients with Pulmonary Hypertension associated with Interstitial Lung Disease (PH-ILD), as well as updated interim results from the Pulmonary Arterial Hypertension (PAH) Phase 3 trial, INOvation-1. As quoted in …
Bellerophon Therapeutics (Nasdaq:BLPH) a clinical-stage biotherapeutics company, today provided an update on the Company’s ongoing Phase 2b randomized, double-blind, placebo-controlled clinical study (iNO-PF) evaluating INOpulse in patients with Pulmonary Hypertension associated with Interstitial Lung Disease (PH-ILD), as well as updated interim results from the Pulmonary Arterial Hypertension (PAH) Phase 3 trial, INOvation-1.
As quoted in the press release:
Bellerophon has completed enrollment of the planned 40 subjects in the iNO-PF trial, with top-line results for this cohort expected in January 2019. These subjects are randomized (1:1) to iNO 30 (30 mcg/kg IBW/hr) vs. placebo, with a one-week run-in period, followed by an eight-week double-blinded treatment period. Following completion of the blinded treatment period, subjects are offered open-label access. The study is evaluating multiple endpoints, including change in six-minute walk distance (6MWD), oxygen saturation, right ventricular function, activity monitoring, patient reported outcomes, as well as several composite endpoints.
In order to support a potential registration package, the Company will expand the iNO-PF study to assess higher doses of iNO and duration of treatment through the addition of two further cohorts. Cohort 2 will include approximately 20 subjects randomized (2:1) to receive either iNO 45 or placebo. Cohort 3 will include approximately 20 subjects randomized (2:1) to receive either iNO 75 or placebo. In addition to evaluating higher doses, cohorts 2 and 3 will increase the blinded treatment period from 8 weeks to 16 weeks. Enrollment in these additional cohorts is expected to begin later this year, with top-line data anticipated in 2019. In addition to the further cohorts, the study is also being modified to allow dose escalation during the open-label period.