Drug Development, Results

PAH therapy tanks in Phase III, obliterating Bellerophon’s stock

Bellerophon, a small company in New Jersey, has lost its bet that it could treat high blood pressure in the lungs with its last-stage lead therapy. The company’s stock is crashing on the news that its Phase III trial is being scrapped midway.

Fabian Tenenbaum

Why is Bellerophon ditching the effort? Futility. An interim analysis showed the first 75 patients enrolled in the pulmonary arterial hypertension (PAH) trial were not responding as hoped. The Data Monitoring Committee deemed the overall change in 6 minute walk distance — the primary endpoint of the trial — “insufficient to support the continuation of the study.”

The company was testing its technology called the INOpulse, which delivers inhaled nitric oxide to patients’ respiratory system in pulses. The company describes the device as an extension of the continuous flow inhaled nitric oxide system that hospitals use on newborns. This trial was Bellerophon’s most advanced program, and its remaining pipeline is also dependent on this platform working.

Investors are not happy. The company’s stock $BLPH nosedived 72% when the market opened Tuesday morning, delivering Bellerophon to penny-stock territory. As of press time, shares were going for $0.62.

The company’s CEO Fabian Tenenbaum had this to say in a statement:

While we are disappointed in the overall efficacy results of this study, we are encouraged by the positive data in hemodynamics and pleased with the safety and tolerability profile of INOpulse. 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.

Bellerophon says it has enough resources to get through the first half of 2019.


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