A Cytokinetics drug candidate under development for the treatment of the same rare heart disease as the Bristol-Myers Squibb drug, which was acquired in a multi-billion dollar transaction, is now encouraging clinical information Pave the way for key tests in the plan.
Cytokinetics drug CK-274 is a potential treatment for hypertrophic cardiomyopathy (HCM), a disease of abnormally thickened myocardium. This thickening makes it difficult for the left ventricle of the heart to pump blood, so patients experience chest pain, dizziness, fatigue, shortness of breath, and in some cases heart failure. The data reported by the South San Francisco-based biotechnology company on Monday came from the second phase of the dose discovery study. But the preliminary results of the trial called REDWOOD HCM also showed that CK-274 treatment resulted in a statistically significant improvement compared to placebo.
“We believe that these results announced today from REDWOOD-HCM provide more motivation for our voyage, because we will continue to push CK-274 forward and now plan to start the third phase of the test before the end of this year,” the chief executive officer Officer Robert Bloom said on the conference call.
Cytokinetics’ stock opened at $27.91 on Monday, a 45.1% increase from Friday’s closing price.
HCM is characterized by excessive contraction, which is another way of saying that excessive contraction of the heart muscle leads to thickening of the heart muscle. The Cytokinetics drug is found internally and is a small molecule designed to block a heart muscle protein called myosin.
Cytokinetics drugs were tested in a double-blind, placebo-controlled Phase 2 study. Patients were randomly assigned to one of the two groups and were given up to three increasing doses of once-daily pills, or the third group was given a placebo. The main goal is to evaluate the safety and effectiveness of the drug. Secondary goals include measuring the effect of the drug on left ventricular blood flow during the 10-week treatment period.
Among the 14 patients in the first group given the lower dose range, 78.6% of the patients reached the treatment goal by week 10, compared with 7.7 in the placebo group. In the second group of patients who received the higher dose range, 92.9% of patients reached the goal. Cytokinetics reported that patients tolerated the drug well and there were no serious adverse events attributable to the drug. In addition, no new cases of atrial fibrillation have been reported among patients treated with CK-274.
Myosin inhibition is also the method adopted by mavacamten, which is a drug, approved by Bristol-Myers Squibb Acquired MyoKardia for USD 13.1 billion last year. In March, the FDA accepted Bristol-Myers Squibb’s new drug application for the drug has set the target date for regulatory decisions on January 28, 2022.
For Cytokinetics, the CY-274 data marks a shift in the recent decline. The company’s two amyotrophic lateral sclerosis drug candidates failed in clinical trials. 2017 first Followed by a The second in 2019In addition, the Amgen research partnership ended in May, and the separate partnership with Astellas will termination November.
The Amgen Alliance covers Cytokinetics’ main drug candidate omecamtiv mecarbil, a cardiac myosin activator. The drug is in Phase 3 testing as a potential treatment for heart failure with reduced ejection fraction. Now that Amgen has severed its connection with the drug, Cytokinetics is focusing on commercializing its two main cardiac drugs separately. The new CY-274 data also supports the development of small molecules as treatments for other diseases, but Blum declined to disclose the diseases the company is considering.
“We haven’t elaborated on our plans for other indications, but this clearly adds to our belief that CK-274 is being advanced not only in obstructive diseases, but also in non-obstructive and other indications,” Blum said . “So, as we expected, we have now demonstrated that CK 274 has the next characteristic that we think will be presented in a series of indications.”
Photo: poshfoto, Getty Images
