Bellerophon Therapeutics’ drug-device fails another PhIII in lung disease, stock implodes

In the five years since Bellerophon Therapeutics’ only program, a device for administering inhaled nitric oxide called INOpulse, flunked its first Phase III study, the New Jersey biotech has kept at it, starting multiple new trials in different indications.

But now the program has failed another Phase III study — definitively.

INOpulse, the company reported, did not meet the primary endpoint in a trial with 145 patients with fibrotic interstitial lung disease. Going to the secondary endpoints, Bellerophon found “minimal difference” between the treatment and placebo group, “with none approaching statistical significance.”

Shares of the biotech $BLPH tanked 85% to just over $1.

Peter Fernandes

The overall outcome of this pivotal study “is conclusive, and we do not see a path forward for continuing” the trial, Bellerophon CEO Peter Fernandes said in a statement.

Bellerophon had billed the Phase III readout as a “critical milestone” after previous attempts to establish INOpulse as a treatment for pulmonary arterial hypertension and Covid-19 proved futile.

The REBUILD trial began in 2020, with the primary endpoint being the change in how much moderate to vigorous physical activity patients performed per day. After 16 weeks, patients who received INOpulse actually performed worse than those on placebo — by 5.49 minutes per day, although the result was not statistically significant (p=0.2646).

Although INOpulse looked better on certain secondary endpoints, such as overall activity per day and 6-minute walk distance, the p-values were similarly uninstructive. Other metrics, such as patient-reported outcomes and side effects, were slightly in favor of placebo, but again not statistically significant.

On a conference call, Fernandes noted the demographics and baseline characteristics of patients between the INOpulse and placebo arms were balanced, suggesting no confounding factors could be blamed for the result.

“Overall, there were no safety signals or trends that we’ve seen,” he said. “Unfortunately, we did not detect clinical or measurable difference in our primary endpoint, which then deems the study as a futile study.”

Bellerophon is also testing INOpulse in chronic obstructive pulmonary disease and sarcoidosis, a rare condition that causes small patches of swollen tissue to develop in organs.

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