Exhibit 99.1

 

MyoKardia Reports Second Quarter 2018 Financial Results

 

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

 

SOUTH SAN FRANCISCO, Calif., August 8, 2018

– MyoKardia, Inc. (Nasdaq: MYOK), a clinical-stage biopharmaceutical company pioneering precision medicine for the treatment of cardiovascular diseases, today reported financial results for the quarter ended June 30, 2018.  

 

“This quarter saw MyoKardia initiate three new clinical studies, including the advancement of our lead investigational compound, mavacamten, into a pivotal Phase 3 clinical trial which represents one of the most important milestones in MyoKardia’s five-year history. The EXPLORER-HCM study should provide meaningful data on how mavacamten treatment impacts patients’ symptoms and how they function, potentially leading the way to a new and much-needed treatment option for people with obstructive hypertrophic cardiomyopathy,” said Tassos Gianakakos, Chief Executive Officer. “Advancements across our broader pipeline can also be expected in the coming months as MYK-491 enters into a Phase 2 clinical trial in dilated cardiomyopathy and data from our ongoing Phase 1 study in DCM patients become available.  Additionally, our research platform and discovery-stage pipeline continue to advance, and we look forward to sharing more details about our research programs in the coming months.”

 

Recent Clinical Program Highlights

 

Mavacamten for Hypertrophic Cardiomyopathy (HCM)

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Dosed First Patient in Phase 3 EXPLORER-HCM Clinical Trial of Mavacamten in oHCM: The pivotal EXPLORER-HCM trial will enroll 220 patients with obstructive hypertrophic cardiomyopathy (oHCM), randomized to receive individualized doses of mavacamten or placebo.  The primary endpoint for the study will be clinical response. Clinical response can be achieved by meeting either of two definitions: 1) an improvement of at least 1.5 mL/kg/min in peak VO2 accompanied by a reduction from baseline of at least one New York Heart Association (NYHA) functional class, or 2) an improvement from baseline of 3.0 mL/kg/min or greater in peak VO2 without worsening in NYHA functional class.  MyoKardia expects to report topline results from the Phase 3 trial in the second half of 2020.

 

o

A long-term extension (LTE) study of patients who complete the Phase 3 EXPLORER-HCM or the Phase 2 MAVERICK-HCM trial is expected to begin by the end of 2018. The Mava-LTE study is part of the overall mavacamten registration package reviewed with the FDA.

 

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Dosed First Patient in Phase 2 MAVERICK-HCM Clinical Trial of Mavacamten in nHCM: The Phase 2 MAVERICK-HCM trial is designed to assess the safety and tolerability of a 16-week treatment course of mavacamten in patients with symptomatic, non-obstructive HCM (nHCM).  The MAVERICK-HCM trial will enroll approximately 60 patients, randomized into three groups to receive either one of two dose concentrations of mavacamten or placebo.  MyoKardia expects to report data from the MAVERICK-HCM study in the second half of 2019.

 

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Enrolled First Patient in PIONEER Open-Label Extension Study: Enrollment of patients who previously completed the Phase 2 PIONEER-HCM trial has begun in the open-label extension study, PIONEER-OLE.  The PIONEER-OLE study is intended to provide data on longer-term exposure to mavacamten.  MyoKardia expects to report interim data from this trial in the first quarter of 2019.  

 

MYK-491 for Dilated Cardiomyopathy (DCM)

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Continued Enrollment in Phase 1b Clinical trial of MYK-491 in DCM Patients:  The randomized, double-blind, placebo-controlled Phase 1b trial of MYK-491 in symptomatic DCM patients is ongoing.   The objectives of this trial are to assess safety, tolerability, preliminary pharmacokinetics and pharmacodynamics of MYK-491 in DCM patients, and MyoKardia expects to report data in the second half of 2018.  A Phase 2 clinical study of MYK-491 in DCM patients is expected to begin in the second half of 2018.

 


The following information was filed by Myokardia Inc (MYOK) on Wednesday, August 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-Q Quarterly Report statement of earnings and operation as management may choose to highlight particular information in the press release.

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