Bellerophon Therapeutics Plunges As Late-Stage PAH Trial Fails Following Interim Analysis

Published: Aug 07, 2018 By

Pulmonary Hypertension

Shares of Bellerophon Therapeutics have plunged nearly 75 percent this morning after the company announced its Phase III pulmonary arterial hypertension (PAH) failed to meet endpoints following a pre-specified interim analysis from a Data Monitoring Committee.

Bellerophon said the late-stage PAH trial investigating INOpulse will be stopped for futility. The decision was based on the analysis of the first 75 patients enrolled in the INOvation-1 study after 16 weeks of treatment. The pre-specified analysis was conducted after half of the trial subjects completed 16 weeks of blinded treatment, Bellerophon said.

Warren, N.J.-based Bellerophon said trial data showed treatment with INOpulse sparked some improvement in pulmonary vascular resistance. However, the data monitoring committee deemed the primary endpoint of the trial, an overall change in the six-minute walk distance, was insufficient to support the continuation of the study.

Pulmonary arterial hypertension is high blood pressure in the lungs.  PAH occurs when the very small arteries throughout the lungs narrow in diameter, which increases the resistance to blood flow through the lungs. Over time, the increased blood pressure can damage the heart. 

Fabian Tenenbaum, chief executive officer of Bellerophon, attempted to put a positive spin on things. He noted the company was disappointed in the early stoppage of the trial but said they were “encouraged” by the positive data in hemodynamics. Tenenbaum also said his team is pleased with the safety and tolerability profile of INOpulse.

"Over the next few weeks, we intend to further analyze the full dataset available to us from this interim analysis in order to determine the next steps in our PAH program,” Tenenbaum said in a statement.

Tenenbaum said the company remains positive about the potential of INOpulse, particularly given the results of the Phase II studies in pulmonary hypertension associated with interstitial lung disease (PH-ILD) and 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.  Our ongoing Phase IIb trial in PH-ILD is progressing well, with top-line results expected around the end of 2018.  PH-ILD is a significant unmet medical need which we believe represents a substantial potential market opportunity," Tenenbaum added.

Bellerophon said it has sufficient financial resources to support its currently planned clinical R&D through the first half of 2019. Company stock plunged this morning after the announcement, sending prices well below $1 per share. Bellerophon, trading on the Nasdaq, closed at $2.28 per share on Monday. This morning, prices are down more than 75 percent to 53 cents per share, as of 10:11 a.m.

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