Bellerophon Halts Phase 3 Trial
Following the announcement on Tuesday, shares of the company dipped in dramatic fashion by nearly 70 percent over a one-day trading period.
The news which no investor looks forward to hearing is that a clinical-stage biopharmaceutical company will halt a Phase 3 clinical study.
In this case, Bellerophon Therapeutics (NASDAQ:BLPH) announced Tuesday (August 7) that the Data Monitoring Committee (DMC) recommended its trial for INOvation be stopped for futility.
This comes after the DMC completed its pre-specified interim analysis of the Phase 3 INOvation-1 study evaluating INOpulse for the treatment of pulmonary arterial hypertension (PAH).
The data showed that although the trial was showing improvement in pulmonary vascular resistance, the DMC decided the primary endpoint—change in six minute walking distance—was insufficient to support the continuation of the study.
“We are encouraged by the positive data in hemodynamics and pleased with the safety and tolerability profile of INOpulse,” Fabian Tenenbaum CEO of Bellerophon said in the press release. “Over the next few weeks, we intend to further analyze the full data set available to us from this interim analysis in order to determine the next steps in our PAH program.”
Tenenbaum continued, saying he is remaining positive by the potential of other INOpulse programs in regards to the results of its Phase 2 studies of pulmonary hypertension associated with interstitial lung disease and pulmonary hypertension associated with chronic obstructive pulmonary disease. Both of these additional indications are in Phase 2 clinical studies.
The company still has sufficient resources to support its currently planned activities into the first half of 2019.
Pulmonary arterial hypertension is high blood pressure in the lungs that occurs in patients with very small arteries throughout the lungs narrow in diameter. This increases the resistance to blood flow through the lungs, which can lead to heart damage.
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As mentioned, Bellerophon is still working on other clinical trials, both which meet the company’s focus of addressing unmet medical needs in the treatment of cardiopulmonary diseases.
“Our ongoing Phase 2b trial in PH-ILD is progressing well, with top-line results expected around the end of 2018,” Tenenbaum said. “PH-ILD is a significant unmet medical need which we believe represents a substantial potential market opportunity.”
Investor takeaway
This announcement hasn’t gone unnoticed by investors, with the company’s share price over Tuesday dropping by 68.86 percent to close the trading session at US$0.71.
It may take time for the company to shake off this announcement with its significant decrease in share price, but the company is still on track with its currently planned activities into the first half of 2019. In addition, the company hope to reports top-line results from its ongoing Phase 2b trial.
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Securities Disclosure: I, Gabrielle Lakusta, hold no direct investment interest in any company mentioned in this article.