Cytokinetics Incorporated CYTK released topline results from the SEQUOIA-HCM Phase 3 trial of aficamten in patients with symptomatic obstructive hypertrophic cardiomyopathy (HCM).
Hypertrophic cardiomyopathy typically affects the muscular wall (septum) between the two bottom chambers of the heart (ventricles).
The thickened wall might block blood flow out of the heart.
Also Read: Potential Takeover In Works for Cardiovascular Treatment Focused Cytokinetics.
The results of SEQUOIA-HCM show that treatment with aficamten significantly improved exercise capacity compared to placebo, increasing peak oxygen uptake (pVO2) measured by cardiopulmonary exercise testing (CPET) by a least square mean difference of 1.74 (1.04 - 2.44) mL/kg/min (p=0.000002).
The treatment effect with aficamten was consistent across all prespecified subgroups.
Statistically significant and clinically meaningful improvements were also observed in all 10 prespecified secondary endpoints.
Aficamten was well-tolerated in SEQUOIA-HCM with an adverse event profile comparable to placebo.
Treatment-emergent serious adverse events occurred in 8 (5.6%) and 13 (9.3%) patients on aficamten and placebo, respectively.
Core echocardiographic left ventricular ejection fraction (LVEF) was observed to be <50% in 5 patients (3.5%) on aficamten compared to 1 patient (0.7%) on placebo.
There were no instances of worsening heart failure or treatment interruptions due to low LVEF.
Price Action: CYTK shares are up 63.90% at $74.94 on the last check Wednesday.
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