Go-To-Market Strategy Focuses on Educating Healthcare Professionals, Ensuring Managed Care Access, and Enacting Programs for Patient Access, Education and Support
Clinical Trial Design Announced for SEQUOIA-HCM, Phase 3 Clinical Trial of Aficamten Expected to Begin in Q4
Company Details Plan for Developing a Cardiovascular Franchise
SOUTH SAN FRANCISCO, Calif., Oct. 07, 2021 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) plans to outline the company’s go-to-market strategy for omecamtiv mecarbil in the United States, and present updates on the company’s advancing cardiovascular pipeline and strategies to build a commercial franchise at “Charting the Commercial Course,” an Analyst and Investor Day today at 8:30 AM Eastern Time in New York and live online. The company also plans to present the clinical trial design for SEQUOIA-HCM, the Phase 3 clinical trial of aficamten in patients with obstructive hypertrophic cardiomyopathy (oHCM).
“Cytokinetics is approaching an inflection point after more than two decades of research and development pioneering the field of muscle biology and advancing the pharmacology of myosin modulators. With new key leadership hires and our establishing of strategic commercial capabilities, we are putting in place the architecture for the potential launch of omecamtiv mecarbil in 2022, staging investments with de-risking milestone events and with deliberate focus to building a framework for a potential cardiovascular business franchise as could be enabled by the subsequent launch of aficamten,” said Robert I. Blum, Cytokinetics’ President and Chief Executive Officer. “As aficamten advances into Phase 3 with SEQUOIA-HCM, expected to begin this year, our company is well positioned to deliver on the promise of potential medicines for patients with cardiovascular diseases of impaired muscle function and weakness.”
Go-To-Market Strategy for Omecamtiv Mecarbil
Cytokinetics leadership will outline the go-to-market strategy for omecamtiv mecarbil in the U.S., which will be guided by a sequenced build of core capabilities to ensure success based on key de-risking milestones leading up to the potential launch of omecamtiv mecarbil. The four pillars of the strategy include first, establishing a deep understanding of patients with worsening heart failure and the healthcare providers and associated institutions who treat this subset of heart failure patients. Second, engaging and educating cardiologists who treat patients with worsening heart failure about the disease state and the importance of appropriate treatment. Third, working with payers to ensure affordable managed care access to omecamtiv mecarbil. Finally, supporting patients and caregivers through education, co-pay assistance where applicable, and innovative models for patient support.
SEQUOIA-HCM: Phase 3 Clinical Trial of Aficamten
Cytokinetics is also today presenting the design of SEQUOIA-HCM (Safety, Efficacy, and Quantitative Understanding of Obstruction Impact of Aficamten in HCM). SEQUOIA-HCM is a Phase 3 randomized, placebo-controlled, double-blind, multi-center clinical trial designed to evaluate aficamten in patients with symptomatic oHCM on background medical therapy for 24 weeks. The primary objective is to assess the effect of aficamten on change in peak oxygen uptake (pVO2) measured by cardiopulmonary exercise testing (CPET) from baseline to week 24. Secondary objectives include change in Kansas City Cardiomyopathy Questionnaire (KCCQ) score from baseline to week 12 and week 24, the proportion of patients with ≥1 class improvement in New York Heart Association (NYHA) functional class from baseline to week 12 and week 24, change in post-Valsalva left ventricular outflow tract gradient (LVOT-G) to week 12 and week 24, the proportion of patients with post-Valsalva LVOT-G