- Bellerophon Therapeutics Inc (NASDAQ:BLPH) announced top-line results from its pivotal Phase 3 REBUILD trial evaluating the safety and efficacy of INOpulse for fibrotic Interstitial Lung Disease (fILD).
- One hundred forty-five patients were enrolled and treated with either INOpulse at a dose of iNO45 or a placebo.
- The primary endpoint was the change in moderate to vigorous physical activity (MVPA) as measured by actigraphy after 16 weeks of chronic treatment.
- The trial did not meet its primary endpoint, with iNO45 performing worse than the placebo by 5.49 minutes daily.
- The secondary endpoints demonstrated minimal difference between the two groups, with none approaching statistical significance.
- Overall, INOpulse was well-tolerated with no safety concerns, consistent with what has been observed in the prior Phase 2 studies.
- The overall activity showed a 3.51 count/min benefit in favor of iNO45 (p=0.8572).
- 6 Minute Walk Distance showed 0.19-meter benefit in favor of iNO45 (p=0.9866).
- Patient-reported outcomes (St. George’s Respiratory Questionnaire and UCSD Shortness of Breath) were slightly in favor of placebo, while time-to-event assessments (Clinical Worsening, Clinical Deterioration, and Clinical Improvement) showed little difference, and none were statistically significant.
- Subjects with treatment-emergent adverse events slightly favored the placebo (84.0% vs. 74.3%).
- Earlier this year, Bellerophon entered into a license agreement for INOpulse with Baylor BioSciences.
- Price Action: BLPH shares are down 85% at $1.06 on the last check Monday.
Shell’s Singapore Refinery Gets Repair Works At Single Buoy Mooring Facility: Report
Shell PLC (NYSE: SHEL) has reportedly cut crude oil imports at its Singapore refinery this month for maintenance work and repairs at its single buoy mooring (SBM) facility.
