Bioabsorbable cardiac matrix trial failure drives down micro-cap partners Bellerophon, BioLineRx

Bioabsorbable cardiac matrix--Courtesy of Bellerophon

Bellerophon Therapeutics ($BLPH) spun out of private-equity-backed Ikaria to develop two programs, but now one of these has failed in its first major trial. It reported top-line results of a trial for its bioabsorbable cardiac matrix (BCM) to prevent heart failure after a heart attack.

In response, Wall Street punished Bellerophon, pushing its shares down by almost two-thirds in early trading, with BioLineRx ($BLRX), which licensed the BCM to it, falling by more than 20%. Bellerophon said it will present detailed trial data on Sept. 1 at the European Society of Cardiology meeting in London.

"It is clear that we all need to step back from further clinical development until and until we can develop an alternative path forward," said Bellerophon chairman and CEO Jonathan Peacock on a July 27 conference call about the BCM clinical results. "This could involve combination with emerging tissue regeneration technologies or with a more focused patient group."

Bellerophon CEO Jonathan Peacock

In the trial, known as PRESERVATION I, the BCM was compared to a saline placebo control in 303 patients randomized at a 2:1 ratio to receive BCM vs. placebo. The trial was designed to assess the prevention of ventricular remodeling and heart failure in patients who had successful percutaneous coronary intervention (PCI) with stent placement after a ST-elevation myocardial infarction.

But researchers found "no statistically significant differences" between BCM and placebo groups for the primary endpoint of change in left ventricular end diastolic volume index at 6 months compared to baseline. Neither was there any differentiation on the secondary endpoints: the 6-minute walk test, the New York Heart Association functional classification (physician reported), the time to cardiovascular death or the nonfatal heart failure events or cardiovascular hospitalizations.

BCM is a sterile formulation of sodium alginate and calcium gluconate, which transforms from a liquid state into a hydrogel when it comes in contact with the elevated calcium levels in injured tissues. It's designed to be administered via the coronary artery during a PCI.

Bellerophon said it would take a few weeks to reassess the clinical development of BCM. But both partners were already emphasizing other development, suggesting it won't remain a top priority. The Ikaria spinout noted that up next for it is the start of one of two Phase III trials for its other program, INOpulse to treat pulmonary hypertension associated with chronic obstructive pulmonary disorder and pulmonary fibrosis. This is slated to start before year end, and the company noted it's already set aside $50 million in cash specifically for this new trial.

Bellerophon went public in February with a share price of $12, but since then, its shares have declined precipitously to less than $2. A year ago, it had brought on high-profile former Amgen exec Jonathan Peacock to lead the company.

Its Israel-based partner chose to emphasize that, for its part, the company has made more money than it's lost on the program. BCM, also known as BL-1040, was in-licensed by Ikaria in 2009 from BioLineRx, which said it has spent about $10 million to develop it--but has made $17 million under the licensing deal.

- here are the Bellerophon and BioLineRx statements
- and here is a webcast of the July 27 conference call

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