Initial Data from REDWOOD-HCM OLE, the Open Label Extension Study of Aficamten, to be Presented at Heart Failure 2022 on May 23, 2022
Continued Launch Readiness Activities and Buildout of Commercial Infrastructure in Advance of PDUFA Date of November 30, 2022 for Omecamtiv Mecarbil
SOUTH SAN FRANCISCO, Calif., May 04, 2022 (GLOBE NEWSWIRE) -- Cytokinetics, Incorporated (Nasdaq: CYTK) reported financial results for the first quarter of 2022. Net loss for the first quarter was $89.4 million, or $1.05 per share, compared to net loss for the first quarter of 2021 of $47.1 million, or $0.66 per share. Cash, cash equivalents and investments totaled $686.1 million at March 31, 2022.
“We achieved meaningful progress during the first quarter of 2022 with especially notable milestones relating to our cardiovascular pipeline, including the acceptance and filing of our NDA for omecamtiv mecarbil with FDA and the opening to enrollment in both SEQUOIA-HCM and Cohort 4 of REDWOOD-HCM. Additionally we shared positive data from Cohort 3 of REDWOOD-HCM demonstrating a substantial treatment effect with aficamten in patients taking disopyramide, and additional data from GALACTIC-HF reinforcing its safety, ease of initiation in the hospital setting and potential to reduce costs associated with fewer hospitalizations,” said Robert I. Blum, Cytokinetics’ President and Chief Executive Officer. “Having secured long-term capital from Royalty Pharma also in the first quarter, our stronger balance sheet enables us to both accelerate our development of aficamten as well as to advance commercial readiness activities supportive of the potential approval of omecamtiv mecarbil this year.”
Q1 and Recent Highlights
Cardiac Muscle Programs
omecamtiv mecarbil (cardiac myosin activator)
- The U.S. Food and Drug Administration (FDA) accepted and filed our New Drug Application (NDA) for omecamtiv mecarbil for the treatment of heart failure with reduced ejection fraction (HFrEF). The NDA was assigned standard review with a Prescription Drug User Fee Act (PDUFA) target action date of November 30, 2022.
- Continued building our commercial infrastructure and launch readiness capabilities for omecamtiv mecarbil in the U.S. including initiation of hiring first line field-based sales force leaders, selection of a patient services partner, and activities related to field force operations and market access.
- Doubled the size of our therapeutic Medical Scientist team, hired a Field Director, and began recruitment for our Managed Healthcare Medical Scientist team.
- Completed risk assessment of an end-to-end supply chain and advanced appropriate mitigating actions; initiated several major digital systems supportive of supply chain logistics.
- Presented additional data from GALACTIC-HF (Global Approach to Lowering Adverse Cardiac Outcomes Through Improving Contractility in Heart Failure) at the American College of Cardiology 71st Annual Scientific Session (ACC.22) including:
- An analysis showing that a subgroup of patients in GALACTIC-HF treated with omecamtiv mecarbil led to a reduction in resource intensity, with an estimated cost offset of $3,085, or 19% reduction per patient. The majority of these cost reductions were due to heart failure hospitalizations avoided by patients who were treated with omecamtiv mecarbil.
- An analysis showing that the effect of treatment with omecamtiv mecarbil was associated with similar risk reduction in the primary composite endpoint in both hospitalized patients and in outpatients, indicating that initiation of omecamtiv mecarbil was safe and well tolerated in both hospitalized patients and outpatients.
- Announced results of METEORIC-HF (Multicenter Exercise Tolerance Evaluation of Omecamtiv Mecarbil Related to Increased Contractility in Heart Failure), a Phase 3 clinical trial of omecamtiv mecarbil in patients with HFrEF that evaluated the effect of treatment with omecamtiv mecarbil compared to placebo on exercise capacity as determined by cardiopulmonary exercise testing (CPET). After 20 weeks of treatment, there was no change in peak oxygen uptake (pVO2) in patients treated with omecamtiv mecarbil versus placebo. Adverse events, including major cardiac events, were similar between the treatment arms, and the safety profile of omecamtiv mecarbil was consistent with prior clinical trials, including GALACTIC-HF.
- Published a manuscript entitled “Influence of Atrial Fibrillation on Efficacy and Safety of Omecamtiv Mecarbil in Heart Failure: The GALACTIC-HF Trial” in the European Heart Journal.
- Published a manuscript entitled “Developments in Exercise Capacity Assessment in Heart Failure Clinical Trials and the Rationale for the Design of METEORIC-HF” in Circulation: Heart Failure.
aficamten (cardiac myosin inhibitor)
- Announced positive data from Cohort 3 of REDWOOD-HCM (Randomized Evaluation of Dosing With CK-274 in Obstructive Outflow Disease in HCM), which enrolled patients with symptomatic obstructive hypertrophic cardiomyopathy (HCM) and a resting left ventricular outflow tract gradient (LVOT-G) ≥50, or resting LVOT-G ≥30 mmHg and post-Valsalva LVOT-G ≥50 mmHg, whose background therapy included disopyramide and in the majority a beta-adrenergic blocker. Results showed that substantial reductions in the average resting LVOT-G as well as the post-Valsalva LVOT-G (defined as resting gradient