Bellerophon Therapeutics Stock Nosedive: Here's Why

Bellerophon Therapeutics Inc 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.

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