Cytokinetics as we speak launched optimistic outcomes from Sequoia-HCM, its Section 3 medical trial of the experimental drug aficamten in sufferers with symptomatic obstructive hypertrophic cardiomyopathy (HCM). Sufferers handled with aficamten confirmed considerably elevated train capability as demonstrated by a 1.74 level improve in peak oxygen uptake (pVO2) measured throughout cardiopulmonary train testing. Enhancements had been additionally seen in provoked outflow tract gradients, and most significantly, sufferers felt higher.
The research had enrollment of roughly 300 sufferers who had been adopted for twenty-four weeks.
Aficamten was well-tolerated, hostile occasions had been similar to these taking a placebo, and importantly, there have been no situations of worsening coronary heart failure or therapy interruptions resulting from low left ventricular ejection fraction (LVEF).
In line with an article in Med Metropolis Information, the drug could have a bonus over the Bristol Myers Squibb drug mavacamten (bought below the model title Camzyos) as a result of there have been no studies of worsening coronary heart failure. Within the Section 3 EXPLORER trial of mavacamten, seven sufferers within the therapy group skilled reductions to their LVEF.
Based mostly on the projected success of aficamten, Cytokinetics inventory value jumped by 83% and the corporate is claimed to be the topic of takeover curiosity from AstraZeneca and Novartis.
Cytokinetics plans to use for FDA approval for the drug within the second half of 2024.
Full outcomes from SEQUOIA-HCM might be introduced at an upcoming medical convention.
You possibly can learn extra concerning the drug in these earlier articles on HCMBeat:
Cytokinetics Teases Upcoming Section 3 Aficamten Trial in nHCM
Promising Information about Aficamten Introduced at Conferences
Aficamten Updates from Cytokinetics
Extra on Aficamten & Mavacamten from ACC 2022
Aficamten Will get “Breakthrough Drug” Standing from FDA
Cytokinetic’s Drug Aficamten & Upcoming HCM Summit – Interview with Dr. Martin Maron
Outcomes Revealed from REDWOOD-HCM Section 2 Trial
The Way forward for HCM Remedy