Bellerophon announced Tuesday that a data monitoring committee (DMC) recommended that the Phase III INOvation-1 trial of the company's pulsatile nitric oxide delivery system INOpulse in pulmonary arterial hypertension (PAH) be stopped for futility. CEO Fabian Tenenbaum stated "over the next few weeks, we intend to further analyse the full data set available to us from this interim analysis in order to determine the next steps in our PAH programme."
Bellerophon noted that the DMC conducted an interim analysis after the first 75 enrolled participants, half of the planned study group, completed 16 weeks of treatment as per its agreement with the FDA. The company said that although no safety concerns were identified and the data showed an improvement in pulmonary vascular resistance, the DMC concluded that the overall change in six-minute walking distance, the study's primary endpoint, did not support continuation of the trial.
Tenenbaum remarked "while we are disappointed in the overall efficacy results of this study, we are encouraged by the positive data in haemodynamics and pleased with the safety and tolerability profile of INOpulse." Shares in the company plummeted as much as 68 percent on the news.
The CEO indicated that the drugmaker will continue to develop the therapy for other indications, including pulmonary hypertension associated with interstitial lung disease (PH-ILD), with mid-stage data anticipated around the end of this year, as well as pulmonary hypertension associated with chronic obstructive pulmonary disease (PH-COPD). "Unlike PAH, patients with PH-ILD and PH-COPD have underlying lung disease for which systemic vasodilators have been ineffective and there are currently no approved therapies," Tenenbaum noted.
Meanwhile, Bellerophon stated that it has sufficient resources to support its currently planned activities into the first half of 2019.
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