Exhibit 99.1

 

MyoKardia Reports Fourth Quarter and Full Year 2017 Financial Results

 

Announced Achievement of Primary Endpoint and Additional Key Data from Low-Dose Mavacamten Cohort of PIONEER-HCM Phase 2 Study in Symptomatic, Obstructive Hypertrophic Cardiomyopathy

 

Company to Host Conference Call and Webcast Today at 4:30 p.m. ET (1:30 p.m. PT)

 

SOUTH SAN FRANCISCO, Calif., March 8, 2018

– MyoKardia, Inc. (Nasdaq: MYOK), a clinical-stage biopharmaceutical company pioneering a precision medicine approach for the treatment of heritable cardiovascular diseases, today reported financial results for the fourth quarter and full year ended December 31, 2017. In addition, the company also announced positive results from the PIONEER-HCM Phase 2 proof-of-concept trial, including results from the low-dose cohort, in a press release issued this afternoon.

 

“Following an eventful and important year of progress, we are poised in 2018 to move closer to achieving our mission to change the lives of patients suffering from serious cardiovascular diseases,” said Tassos Gianakakos, Chief Executive Officer.  “As we prepare to initiate our Phase 3 EXPLORER-HCM pivotal trial, the additional PIONEER-HCM study data announced today increase our confidence in mavacamten’s potential to help patients with oHCM.  This enthusiasm carries over into our growing clinical pipeline, which also includes the Phase 2 study of mavacamten in non-obstructive HCM and the continued clinical study of MYK-491 in dilated cardiomyopathy patients.”

 

Full Year 2017 and Recent Clinical Program Highlights

 

Mavacamten for Hypertrophic Cardiomyopathy (HCM)

 

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Mavacamten Met Primary Endpoint and Key Secondary Endpoints of PIONEER-HCM Study in Both Study Cohorts:  In the PIONEER-HCM Phase 2 clinical trial of 21 symptomatic obstructive HCM patients, mavacamten achieved the primary endpoint of reduction in post-exercise left ventricular outflow tract (LVOT) gradient from baseline to week 12 with statistical significance across both cohorts tested.  Improvements in peak VO2, New York Heart Association (NYHA) classification and dyspnea rating scores were also observed.  Mavacamten was generally well-tolerated.

 

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Mavacamten Activity was Persistent and Safety was not Discernably Impacted by Use of Background Beta Blockers: Benefits were observed across endpoints among those taking once-daily 2mg and 5mg doses of mavacamten who remained on background beta blocker therapy (“Cohort B”), and those who received daily doses ranging from 10mg, 15mg and 20mg who had discontinued background medications (as presented at the Heart Failure Society of America Annual Meeting in September 2017).

 

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Target Concentration Range Identified to Inform EXPLORER-HCM Trial:  The PIONEER-HCM study has informed a target concentration range at which mavacamten is expected to achieve a clinical improvement in oHCM symptoms (e.g., NYHA class) and exercise capacity (peak VO2) while maintaining normal ejection fraction of greater than or equal to 50 percent. Data from the PIONEER-HCM study will guide the starting dose and inform dose-adjustments for MyoKardia’s planned Phase 3 pivotal EXPLORER-HCM clinical trial expected to start in the second quarter of 2018.  

 

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Mavacamten Registration Program Outlined with FDA in September: MyoKardia established key elements of the registration program for mavacamten in symptomatic oHCM, including the Phase 3 EXPLORER-HCM clinical trial and a planned long-term extension study in consultation with the U.S. Food and Drug Administration’s (FDA) Division of Cardiovascular and Renal Products during an end-of-Phase 2 meeting following results from the first cohort of the PIONEER-HCM clinical trial.  

 

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Presented New Data at AHA:  MyoKardia researchers presented new digital health and in vivo preclinical data related to its mavacamten program at the American Heart Association Scientific Sessions in November 2017.

 


The following information was filed by Myokardia Inc (MYOK) on Thursday, March 8, 2018 as an 8K 2.02 statement, which is an earnings press release pertaining to results of operations and financial condition. It may be helpful to assess the quality of management by comparing the information in the press release to the information in the accompanying 10-K Annual Report statement of earnings and operation as management may choose to highlight particular information in the press release.

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