BioPharma, SYN

Pfizer bows out of developing cardio drug, returns rights to Ionis Pharmaceuticals

After reviewing Phase 2B clinical data, the New York drugmaker and its partner Ionis Pharmaceuticals announced that Pfizer was abandoning the development of a cardiovascular drug, thereby returning the rights to Ionis.

Sometimes even a clinical trial where the endpoints have been met may not give the confidence to forge ahead.

That was the scenario Pfizer found itself in with respect to the drug vupanorsen, an antisense therapy that was being tested to find potential indications in cardiovascular (CV) risk reduction and severe hypertriglyceridemia. After reviewing Phase 2B clinical data, the New York drugmaker and its partner Ionis Pharmaceuticals announced Monday that it was abandoning the development of the drug, thereby returning the rights to  Ionis.

Back in November, Pfizer had announced that the drug achieved a “statistically significant reduction in non-high density lipoprotein cholesterol (non-HDL-C) – as well as a statistically significant reduction in the secondary endpoint of triglycerides (TG) – at all dose levels, compared to placebo.” That study, enrolled 286 participants 40 years of age and older with dyslipidemia — people with elevated non-HDL-C and TG who are receiving a stable dose of a statin with or without ezetimibe, according to the news release.

However, a closer reading of the news release citing the positive clinical trial results seems to show that even then there were doubts. James Rusnak, senior vice president and chief development officer, internal medicine and hospital, Pfizer, stated that Pfizer would “carefully consider these findings to determine the appropriate next steps regarding future development.”

A mere two months later, Pfizer is making the decision that while “statistically significant” the magnitude of reductions was not material. Vupanorsen was also found to have resulted in dose-dependent increases in liver fat. Those who received higher doses also showed elevations in the liver enzymes alanine aminotransferase (ALT) and aspartate aminotransferase (AST), indicative of liver damage.

So the logical next step in development is essentially to cease completely.

“Pfizer remains dedicated to research and development in the cardiovascular category and helping to address the unmet medical needs of patients with cardiovascular diseases,” said James Rusnak, senior vice president and chief development officer, internal medicine and hospital, Pfizer, in Monday’s news release. “We are grateful to the patients, investigators and support staff who have participated in this important research program.”

Pfizer had paid $250 million upfront to license the rights to develop the drug from Carlsbad, California-based Ionis and its affiliate. Ionis’ stock briefly dipped on Monday before closing at $31.80 on Monday, up from $31.68 on Friday.

With the New York company bowing out, no large competitor will now exist to Regeneron, which received FDA approval for Evkeeza nearly a year ago. The drug is an antibody designed to bind to and block angiopoietin-like 3 – ANGPTL3 – a protein key to lipid metabolism. The approval marked the first FDA-approved therapy that works in this way.

ANGPTL3 has become an emerging therapy target to understand cardiovascular risk.

Picture: Ekkaluck, Getty Images

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