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In patients with symptomatic obstructive hypertrophic cardiomyopathy (oHCM), Mavacamten is a potential first-in-class myosin inhibitor. In the EXPLORER-HCM trial, compared with placebo, it was healthy at 30 weeks. Condition has improved
New analysis results also published in Lancet
Bristol Myers Squibb (New York Stock Exchange:BMY) Today announced a new data analysis from the Phase 3 EXPLORER-HCM study, which evaluated the research-leading myocardial myosin inhibitor mavacamten in patients with obstructive hypertrophic cardiomyopathy (oHCM). The drug has been published in the American College of Cardiology. 70day Annual Scientific Conference (ACC.21), also published in Lancet. At 30 weeks, the total summary score of the Kansas City Cardiomyopathy Questionnaire (KCCQ OSS) for patients with Mavatan disease changed more than placebo, with similar benefits in all KCCQ subscales. In addition, compared with placebo, a larger proportion of mavacamten patients achieved a very large and clinically significant improvement in KCCQ OSS (≥20 points) [33/92] Contrast 15% [13/88]. Need to change at least 5 points to be considered clinically meaningful. These results were presented today as part of the “Featured Clinical Research I” section (403-09) of the Hot Topics Channel at 12:15-1:30 pm Eastern Time.
“KCCQ is a disease-specific questionnaire for 23 diseases, used to quantify symptoms, physical function, social function, and quality of life. By using this tool, we can prove that the drug is substantive to patients taking mavacatan The clinical benefit, and when the patient takes it, this effect is attenuated by the end of the study,” Dr. John A. Spertus, lead research researcher, Clinical Director of Outcome Research at St. Luke’s Central American Heart Institute, Missouri Raul Missouri Foundation and Professor of Medicine at Kansas City University. “This new analysis of EXPLORER-HCM data provides important insights that inhibiting myosin can improve the health of patients with severe obstructive hypertrophic cardiomyopathy, a chronic, often debilitating disease.”
In a three-stage, double-blind, placebo-controlled trial, patients with symptomatic oHCM (LVOT gradient ≥50mmHg and NYHA II-III) were randomly assigned to mavacamten (n = 123) or placebo ( n = 128) for 30 weeks, followed by 8 weeks of flushing. KCCQ was administered at baseline and at 6, 12, 18, 30, and 38 weeks. Using mixed model repeated measurement and responder analysis, the change of KCCQ score compared with baseline was analyzed.
At baseline and at the 30th week of treatment (end of treatment), a total of 92 patients were randomly assigned to patients receiving mavacamten and 88 patients were randomly assigned to placebo, completing KCCQ.
The survey results include:
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At 30 weeks, the change of KCCQ OSS in the mavactan treatment group was greater than that in the placebo treatment group (mean ± SD, 14.9 ± 16 vs. 5·4 ± 14; difference = 9.1 (95% CI: 5.1) 5-12·8); p<0·001), there are similar returns in all KCCQ subscales.
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The proportion of patients with great changes (KCCQ OSS ≥ 20 points) is 36% [33/92] Contrast 15% [13/88], The estimated absolute difference is 21% (95% CI = 8.8%, 33.4%), and the number of people in need of treatment is 5 (95% CI = 3, 11). Clinically, a change of at least 5 points is considered important. After cessation of active treatment, these benefits returned to baseline.
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At the 30th week, the health status of a larger proportion of placebo patients did not change or deteriorate.
“Jatropha represents Bristol Myers Squibb’s continuous commitment to improve the lives of patients through scientific discoveries, especially those suffering from chronic cardiovascular diseases such as oHCM. ,” said Jay Edelberg, MD, MD, and Bristol Myers Squibb. “The new analysis of the data from the EXPLORER-HCM Phase 3 trial further supports scientific evidence that mavatan can improve the health, symptoms and quality of life of patients with symptomatic oHCM. We look forward to bringing this important new technology Treat patients next year.”
Phase 3 trial of EXPLORER-HCM Mavacamten hypertrophic cardiomyopathy
A total of 251 patients with symptomatic (NYHA II or III) and obstructive hypertrophic cardiomyopathy were included in the EXPLORER-HCM Phase 3 trial. At baseline, all participants had left ventricular outflow tract (LVOT) gradients (resting and/or induced) ≥50 mmHg.
The primary end point of EXPLORER-HCM is a composite function analysis, which aims to capture the effects of mavacatane on symptoms and function. The secondary endpoints are the change in LVOT gradient after exercise from baseline to week 30, pVO2, the proportion of patients with at least one NYHA grade improvement, and patient-reported outcome indicators. Other endpoints include the change in echocardiographic index from baseline to week 30, circulating biomarkers, heart rhythm pattern, and accelerometer.
About hypertrophic cardiomyopathy
Hypertrophic cardiomyopathy or HCM is a chronic progressive disease in which excessive contraction of the myocardium and reduced left ventricular filling capacity may lead to symptoms of weakness and cardiac dysfunction. In HCM patients, fatigue may cause fatigue or shortness of breath, which can interfere with the patient’s ability to participate in activities of daily living. In addition, HCM is also associated with an increased risk of atrial fibrillation, stroke, heart failure, and sudden cardiac death. The most common cause of HCM is a mutation of myocardial protein in the sarcomere. It is estimated that HCM affects one in every 500 people, but there are still many patients who are undiagnosed and/or asymptomatic.
About Mavakamten
Mavacamten is a potential first-class, oral, allosteric modulator of cardiac myosin and is currently being studied to treat potential causes of excessive heart contraction and impaired diastolic filling. Mavacamten reduces myocardial contractility by inhibiting the formation of excessive myosin-actin bridges, which can lead to excessive contraction, left ventricular hypertrophy and reduced compliance. In clinical and preclinical studies, mavacamten continuously reduced biomarkers of heart wall stress, reduced excessive cardiac contractility, and increased diastolic compliance.
About Bristol Myers Squibb
Bristol Myers Squibb (Bristol Myers Squibb) is a global biopharmaceutical company whose mission is to discover, develop and provide innovative drugs that can help patients overcome serious diseases.For more information about Bristol Myers Squibb, please contact us at the following address BMS.com Or follow us LinkedIn, Twitter, YouTube, Facebook with Instagram.
Cautionary statement regarding forward-looking statements
This press release contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995, which involve the research, development, and commercialization of drugs. All statements that are not historical facts are forward-looking statements or may be considered forward-looking statements. Such forward-looking statements are based on historical performance and current expectations and forecasts of our future financial performance, goals, plans and goals, and involve inherent risks, assumptions and uncertainties, including internal factors that may delay, transfer or change any of these factors Or external factors in the next few years, which are difficult to predict, may be beyond our control, and may lead to our future financial results, goals, plans and goals and the content expressed or implied in the statement. Significant differences. These risks, assumptions, uncertainties and other factors especially include the possibility that future research results may be consistent with the results so far, that is, Malvatan may not be adapted as described in this version in the current expected timetable or in the current version. Regulatory approval of the disease. All, if approved, whether the candidate products described in this release for such indications will be commercially successful. No forward-looking statements can be guaranteed. The forward-looking statements in this press release and the many risks and uncertainties that affect Bristol Miles Squibb’s business and markets should be evaluated, especially when it comes to Bristol Miles Squibb The risks and uncertainties identified in the warning statement and the discussion of risk factors in the annual report on Form 10-K. For the fiscal year ending December 31, 2020, our subsequent quarterly report on Form 10-Q, the current report on Form 8-K, and other documents filed with the US Securities and Exchange Commission have been updated. The forward-looking statements contained in this document are only made at the time this document is published, and unless otherwise required by applicable laws, Bristol Myers Squibb assumes no obligation to publicly update or revise any forward-looking statements, whether for the following reasons or not. New information, future events, environmental changes or other circumstances.
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