- Trial did not meet its primary endpoint related to the change in moderate to vigorous physical activity
- INOpulse® was safe and well-tolerated, consistent with the overall safety profile demonstrated in Phase 2 and other INOpulse® programs in PH-COPD and PH-Sarcoidosis
- Company to host conference call and webcast with slides today at
8:30 AM ET
The REBUILD clinical trial was designed as a randomized, double-blind, placebo-controlled Phase 3 study evaluating the safety and efficacy of INOpulse® for the treatment of patients with fILD. A total of 145 fILD 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 placebo by 5.49 minutes per day (p=0.2646). 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.
Key REBUILD clinical trial secondary endpoints and safety outputs assessed over 16 weeks of blinded treatment included:
- Overall Activity showed 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 was slightly in favor of placebo (84.0% vs 74.3%)
- Subjects with serious treatment emergent adverse events was balanced (20% vs 21.4%)
- Deaths were balanced (4.0% vs 4.3%)
“The REBUILD study did not match the outcomes we saw in the exploratory Phase 2 study in this patient population; however, the overall outcome of this pivotal validation study is conclusive and we do not see a path forward for continuing the REBUILD trial,” said
Conference Call and Webcast Information
Bellerophon management will host a conference call and webcst with slides today at
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: risks and uncertainties relating to INOpulse®, 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
Source: Bellerophon Therapeutics, Inc.