EXHIBIT 99.1

 

 

MyoKardia Reports Second Quarter 2019 Financial Results

 

Announces Last Patient to be Enrolled in EXPLORER-HCM Phase 3 during the Week of

August 12th, Topline Data Accelerated to 2nd Quarter 2020

 

Topline Phase 2 Clinical Data from MAVERICK-HCM and MYK-491 on Track for
Fourth Quarter 2019

 

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

 

SOUTH SAN FRANCISCO, Calif., Aug. 07, 2019 -- MyoKardia, Inc. (Nasdaq: MYOK) today reported financial results for the second quarter ended June 30, 2019.

 

“We are now less than a year away from potentially game-changing pivotal data from our EXPLORER-HCM clinical trial of mavacamten in obstructive HCM, with activities in full swing for NDA preparation and potential commercial introduction of MyoKardia’s first product,” said Tassos Gianakakos, MyoKardia’s Chief Executive Officer.  “The remainder of this year will see us share multiple meaningful clinical results including topline data from our Phase 2 MAVERICK-HCM study in patients with non-obstructive HCM and from our Phase 2 study of MYK-491 for patients with stable heart failure.  We will also be advancing our third clinical-stage compound, MYK-224, into a Phase 1 clinical trial.  Taken together, these events highlight the meaningful progress we continue to make in the development of much-needed new treatments for serious cardiovascular diseases.”  

 

Recent Clinical Program Highlights

 

Mavacamten for Hypertrophic Cardiomyopathy (HCM)

 

Enrollment in EXPLORER-HCM Phase 3 Clinical Study Nearing Completion: Patient enrollment for the Phase 3 EXPLORER-HCM registrational clinical study to assess the effect of mavacamten in treating patients with symptomatic, obstructive HCM is scheduled to end next week.  Clinical site engagement was high, allowing for enrollment above the target of 220 patients to be completed ahead of expectations. MyoKardia now anticipates reporting topline data from the EXPLORER-HCM trial in the second quarter of 2020, ahead of the previous guidance of the second half of 2020.

 

 

Completed Enrollment in the MAVERICK-HCM Phase 2 Clinical Trial: In May, MyoKardia announced the completion of enrollment in the Phase 2 MAVERICK-HCM study of mavacamten for the treatment of non-obstructive HCM.  The randomized, double-blind, placebo-controlled MAVERICK-HCM Phase 2 clinical trial is designed to assess the safety and tolerability of a 16-week treatment course of mavacamten in patients with non-obstructive HCM.  MyoKardia plans to report topline data from the MAVERICK-HCM study in the fourth quarter of 2019.

 

 

Published Data in Nature Digital Medicine Showing Potential of Wrist-Worn Biosensor to Screen for Hypertrophic Cardiomyopathy: Results from an exploratory study demonstrated the potential to screen for obstructive HCM using a photoplethysmography (PPG) digital health device, similar to the optical sensors that monitor heart rate on commercially available fitness trackers.  Continuous monitoring with a wrist-worn biosensor revealed differences in arterial pulse wave patterns between obstructive HCM patients and those of individuals without obstructive HCM. MyoKardia’s proprietary machine learning algorithm identified individuals with obstructive HCM with a sensitivity of 0.95 and a specificity of 0.98. The digital health substudy was conducted by MyoKardia as part of the company’s Phase 2 PIONEER-HCM trial of mavacamten.

 

 

Driven by the Heart

 

 

 

333 Allerton Avenue, South San Francisco, CA 94080 / +1 650 741-0900/ myokardia.com

 

 
The following information was filed by Myokardia Inc (MYOK) on Wednesday, August 7, 2019 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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