MyoKardia Presents Data from Study of Machine Learning Algorithm Intended to Identify Obstructive Hypertrophic Cardiomyopathy...
November 13 2017 - 7:15PM
MyoKardia, Inc. (Nasdaq:MYOK), a clinical-stage biopharmaceutical
company pioneering a precision medicine approach for the treatment
of heritable cardiovascular diseases, presented results from
testing a novel machine learning algorithm intended to identify
patients with obstructive hypertrophic cardiomyopathy (oHCM) during
a late-breaker session at the American Heart Association (AHA)
Scientific Sessions.
MyoKardia designed an exploratory digital health substudy as
part of the Phase 2 PIONEER-HCM trial of mavacamten (formerly
MYK-461) to determine if an optical biosensor, similar to those
that monitor heart rate on commercially available fitness trackers,
could identify patients with oHCM. Using an investigational
wrist-worn photoplethysmography (PPG) digital health device,
arterial pulse wave patterns of oHCM patients were shown to be
distinct from those of individuals without oHCM. After
training and cross-validation, MyoKardia’s proprietary machine
learning algorithm identified individuals with oHCM with 95 percent
accuracy, with a sensitivity of 0.95 and a specificity of 0.95.
“Hypertrophic cardiomyopathy affects approximately 630,000
people in the U.S., but an estimated eighty-five percent of
patients go undiagnosed. Use of a wrist-worn digital health
device to identify irregular blood flow patterns and screen
patients for disease as they go about their daily activities could
have a remarkable impact on the diagnosis and treatment of HCM,
particularly given the potential health risks for patients unaware
of their condition,” said Marc Semigran, M.D., Chief Medical
Officer of MyoKardia.
“We believe the data obtained in this study provide
proof-of-principle for the possible use of wearable PPG technology
to screen for obstructive hypertrophic cardiomyopathy,” said
Charles Wolfus, Executive Director, Digital Health, Technology and
Business Operations at MyoKardia. “These results lend
themselves to further testing of our machine learning algorithms,
with the potential to expand its application to different
wrist-worn wearable platforms, to monitor for treatment effects in
oHCM patients, and to screen for other types of
cardiomyopathy.”
About MyoKardia’s Digital Health Substudy Using
an investigational wearable PPG device developed by Wavelet Health,
arterial pulse wave data were collected at baseline from 19 oHCM
patients enrolled in MyoKardia’s PIONEER-HCM clinical trial.
A beat-by-beat machine learning model was developed to identify
digital signatures of oHCM. The pulse wave patterns of oHCM
patients were then analyzed against comparable patterns from a
database of 86 volunteers. The pulse wave patterns of
patients with oHCM were consistent with the turbulent blood flow
and heart rate variability associated with obstruction of the left
ventricular outflow tract (LVOT) characteristic of oHCM.
These data were the subject of today’s late-breaking basic
science oral session in a presentation titled “Machine Learning
Detection of Obstructive Hypertrophic Cardiomyopathy Using a
Wearable Biosensor” (Abstract #24031).
About Hypertrophic CardiomyopathyHypertrophic
cardiomyopathy (HCM) is a genetic condition in which the walls of
the heart thicken and prevent the left ventricle from expanding,
resulting in a reduced pumping capacity. HCM is a progressive
disease that can result in shortness of breath, chest pain,
inability to participate in normal activities, disabling heart
failure and even stroke. HCM is the leading cause of sudden
cardiac death in young people. Obstructive HCM (oHCM) is a
form of HCM characterized by a dynamic obstruction of the LVOT that
results in abnormalities in arterial blood flow. HCM is
typically diagnosed by echocardiogram to visually identify the
thickening of the heart wall, anatomical blood flow obstruction and
heart valve movement.
About Mavacamten (MYK-461) Mavacamten is a
novel, oral, allosteric modulator of cardiac myosin that reduced
hypercontractility in a Phase 1 clinical study of hypertrophic
cardiomyopathy (HCM) patients. MyoKardia has evaluated mavacamten
in multiple Phase 1 clinical studies, primarily designed to
evaluate safety and tolerability of oral doses of mavacamten, and
provide pharmacokinetic and pharmacodynamic data. In April 2016,
the U.S. FDA granted Orphan Drug Designation for mavacamten for the
treatment of symptomatic oHCM, a subset of HCM. MyoKardia is
currently studying mavacamten in the Phase 2 PIONEER-HCM study.
About MyoKardiaMyoKardia is a clinical-stage
biopharmaceutical company pioneering a precision medicine approach
to discover, develop and commercialize targeted therapies for the
treatment of serious and rare cardiovascular diseases.
MyoKardia’s initial focus is on the treatment of heritable
cardiomyopathies, a group of rare, genetically-driven forms of
heart failure that result from biomechanical defects in cardiac
muscle contraction. MyoKardia has used its precision medicine
platform to generate a pipeline of therapeutic programs for the
chronic treatment of the two most prevalent forms of heritable
cardiomyopathy - hypertrophic cardiomyopathy (HCM), and dilated
cardiomyopathy (DCM). MyoKardia’s most advanced product candidate
is mavacamten (formerly MYK-461), a novel, oral, allosteric
modulator of cardiac myosin that has been shown to reduce
hypercontractility in early clinical studies and is currently being
studied in the Phase 2 PIONEER-HCM clinical trial. MYK-491,
MyoKardia’s second product candidate, is designed to increase the
overall extent of the heart’s contraction in DCM patients by
increasing cardiac contractility. MyoKardia is currently evaluating
MYK-491 in a Phase 1 study in healthy volunteers. A cornerstone of
the MyoKardia platform is the Sarcomeric Human Cardiomyopathy
Registry (SHaRe), a multi-center, international repository of
clinical and laboratory data on individuals and families with
genetic heart disease, which MyoKardia helped form in 2014.
MyoKardia’s mission is to change the world for patients with
serious cardiovascular disease through bold and innovative
science.
Contacts:
Michelle Corral
Corporate Communications & Investor Relations
MyoKardia, Inc.
650-351-4690
mcorral@myokardia.com
Steven Cooper (Media)
Edelman
415-486-3264
steven.cooper@edelman.com
Beth DelGiacco (Investors)
Stern Investor Relations, Inc.
212-362-1200
beth@sternir.com
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