SOUTH SAN FRANCISCO, Calif. - Cytokinetics (NASDAQ:CYTK), Incorporated (NASDAQ:CYTK) revealed additional findings from the SEQUOIA-HCM Phase 3 clinical trial of aficamten in patients with symptomatic obstructive hypertrophic cardiomyopathy (HCM), focusing on dosing and safety, as well as the drug's impact on exercise performance.
These findings were shared at the Heart Failure 2024 Congress and concurrently published in the New England Journal of Medicine.
The trial demonstrated that aficamten could be safely administered with dose adjustments based on individual patient response, without major adverse cardiovascular events or treatment interruptions due to low left ventricular ejection fraction (LVEF). Over a 24-week period, the placebo-corrected average change in LVEF for patients treated with aficamten was -4.8%, leading to significant reductions in left ventricular outflow tract gradient (LVOT-G).
The majority of patients reached one of the two highest doses of aficamten, with plasma drug concentrations remaining stable throughout the treatment. Only 3.5% of patients on aficamten had LVEF drop below 50%, with no instances of worsening heart failure or treatment interruptions due to low LVEF.
In terms of exercise performance, aficamten treatment over 24 weeks showed improvement in a novel integrated exercise performance metric, combining peak oxygen uptake (pVO2) and ventilatory efficiency (VE/VCO2).
The placebo-adjusted difference in the integrated CPET Z-score was 0.35, with a significant correlation between improved exercise performance and other clinical measures such as the Kansas City Cardiomyopathy Questionnaire Clinical Summary Score and New York Heart Association Functional Class.
Cytokinetics is hosting an investor event and webcast today to discuss these findings. Aficamten, a cardiac myosin inhibitor, has received Breakthrough Therapy Designation from the U.S. Food & Drug Administration and is also being evaluated in other Phase 3 clinical trials.
The company is focused on the development of muscle activators and inhibitors as potential treatments for cardiovascular diseases where cardiac muscle performance is compromised. These additional results from SEQUOIA-HCM support aficamten's potential as a treatment for obstructive HCM, with continued evaluation in ongoing clinical trials.
This article is based on a press release statement from Cytokinetics, Incorporated.
InvestingPro Insights
In light of Cytokinetics' (NASDAQ:CYTK) recent updates on their SEQUOIA-HCM Phase 3 clinical trial, investors are closely monitoring the company's financial health and market performance. According to InvestingPro data, Cytokinetics has a market capitalization of $6.55 billion, reflecting its size and investor expectations. Despite the promising clinical results, analysts have concerns regarding the company's profitability. The latest data shows a significant revenue decline over the last twelve months as of Q1 2024, with revenue dropping by 96.17%, and gross profit margins are deeply negative at -8755.86%, indicating financial challenges.
InvestingPro Tips highlight a mix of caution and optimism for Cytokinetics. Analysts do not expect the company to be profitable this year, as indicated by a negative P/E ratio of -12.35. Nonetheless, the company has demonstrated a strong return over the last year, with a 64.98% price total return, suggesting that investors have confidence in its long-term prospects. It's worth noting that Cytokinetics' liquid assets exceed its short-term obligations, which could provide some financial flexibility in the near term.
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