Cytokinetics, Inc. (NASDAQ:CYTK) announced the start of a double-blind, randomized, placebo-controlled, multi-center Phase 2 clinical trial to evaluate the safety, pharmacokinetics and efficacy of omecamtiv mecarbil in Japanese subjects with heart failure and reduced ejection fraction. Omecamtiv mecarbil, a novel investigational cardiac myosin activator that increases cardiac contractility, is being developed by Amgen in collaboration with Cytokinetics for the potential treatment of heart failure. “Advancing the clinical investigation of omecamtiv mecarbil in Japan represents an important step for our novel cardiac myosin activator that increases cardiac contractility, is being developed by Amgen in collaboration with Cytokinetics for the potential treatment of heart failure.
“Advancing the clinical investigation of omecamtiv mecarbil in Japan represents an important step for our novel cardiac myosin activator program,” said Fady I. Malik, MD, PhD, Cytokinetics’Executive Vice President, Research and Development. “Omecamtiv mecarbil holds promise as a potential new treatment for patients with heart failure and we look forward to learning about its clinical application in Japanese patients.”
Phase 2 Clinical Trial Design
The ongoing Phase 2 clinical trial of omecamtiv mecarbil in Japan will evaluate approximately 80 subjects with chronic stable heart failure with reduced ejection fraction over 16 weeks randomized 1:1:1:1 to receive either placebo or omecamtiv mecarbil twice daily at 25 mg, 37.5 mg or 50 mg. Subjects randomized to 37.5 mg or 50 mg will be up-titrated using a PK-guided dose titration strategy. The primary objectives of the trial are to assess the pharmacokinetics, safety, and tolerability of omecamtiv mecarbil in Japanese subjects with heart failure and reduced ejection fraction. The secondary objective is to measure changes from baseline in systolic ejection time measured at week 16. (Original Source)
Shares of Cytokinetics closed last Friday at $7.19, up $0.14 or 1.99%. CYTK has a 1-year high of $13.18 and a 1-year low of $5.50. The stock’s 50-day moving average is $6.56 and its 200-day moving average is $8.47.
On the ratings front, Cytokinetics has been the subject of a number of recent research reports. In a report issued on February 17, Cowen analyst Ritu Baral reiterated a Buy rating on CYTK, with a price target f $16, which represents a potential upside of 122.5% from where the stock is currently trading. Separately, on February 16, Roth Capital’s Joseph Pantginis reiterated a Buy rating on the stock and has a price target of $22.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Ritu Baral and Joseph Pantginis have a total average return of 5.0% and -4.1% respectively. Baral has a success rate of 39.4% and is ranked #576 out of 3775 analysts, while Pantginis has a success rate of 37.6% and is ranked #3636.