Omecamtiv disappoints again

The Meteoric-HF trial was not crucial to Cytokinetics’ ambitions for the heart failure asset omecamtiv mecarbil, but the company could still have done with a hit. Instead the study’s failure today narrows the project’s potential market, and heightens tensions over the FDA’s ongoing review. That review is based on Galactic-HF, a trial whose primary analysis managed a weak hit. Cytokinetics is therefore pinning hopes on a subgroup with severe heart failure; the FDA will pronounce on this evidence by the Pdufa date of November 30. Whatever the agency’s verdict, any chance of expanding into a wider population has likely been ruled out by the Meteoric-HF miss. This study showed omecamtiv, a cardiac myosin activator, to be no better than placebo at improving exercise capacity in patients with heart failure with reduced ejection fraction; full data are to come at ACC in early April. According to Mizuho analysts Meteoric-HF could have supported a supplemental filing and a possible 10-20% increase in sales, but they point out that investor expectations were low going into this readout “as they are with omecamtiv in general”. Perhaps this explains the muted share price reaction: Cytokinetics is down just 2% in early trade.