Promising Data about Aficamten Presented at Meetings

Encouraging data about the Cytokinetics investigational drug aficamten was presented over the weekend at 2 scientific meetings held in Washington D.C.

The inaugural Scientific Sessions of the newly formed HCM Society took place on Friday, while the Heart Failure Society of America (HFSA) Annual Scientific Meeting continues through October 3.

Both meetings featured presentations of data from the REDWOOD-HCM Open Label Extension trial.  The REDWOOD trial is a Stage 2 clinical trial of the second generation myosin modulator aficamten.

The HCM Society presentation showed that a significant number of patients on aficamten were able to discontinue one or more background drugs which they had been taking together with aficamten to address their symptoms.

The HFSA presentation, given by Dr. Sara Saberi of the University of Michigan’s HCM Center, showed that in addition to seeing a substantial reduction to left ventricular outflow tract gradients, patients self reported significant improvements to their symptoms and their quality of life. The improvements were evidenced through questionnaires filled out by the patients after 24 weeks on aficamten.

Cytokinetics is currently enrolling patients with symptomatic obstructive HCM in its Stage 3 trial of aficamten, called SEQUOIA – HCM, while they continue looking at the impact of aficamten on non-obstructive HCM in cohort 4 of the REDWOOD-HCM trial.

You can find all of the past HCMBeat blog entries about aficamten in the links below:

2 Companies Testing Drugs for HCM

HCM Clinical Trials – the Latest News

The Future of HCM Care

Positive Signs from REDWOOD-HCM

Cytokinetic’s Drug Aficamten & Upcoming HCM Summit – Interview with Dr. Martin Maron

Aficamten Gets “Breakthrough Drug” Status from FDA

More on Aficamten & Mavacamten from ACC 2022

Cytokinetics Announces its Phase 2 Clinical Trial – “Redwood-HCM”

Cytokinetics Moves Forward with HCM Drug Trial

Cytokinetics Announces Positive Results from REDWOOD-HCM Phase 2 Clinical Trial

Medtronic ICD Recall

The FDA has announced a Class I recall of certain models of Medtronic implantable defibrillators and cardiac resynchronization therapy defibrillators.  The statement from the FDA can be found here.

The recall impacts Medtronic’s Cobalt and Crome brands of ICDs and cardiac resynchronization therapy defibrillators (CRT-Ds) implanted from February 3, 2020 to the present.  The problem is described as a “short circuit protection alert resulting in reduced-energy electric shock delivery instead of delivering a second phase of high voltage therapy.”  A reduced energy electric shock may fail to correct an arrhythmia or may cause an irregular heartbeat.

There have so far been only 27 complaints, but no injuries or deaths associated with the issue which impacts 87,709 devices total.

Medtronic is developing a software update to address the issue which should be available in late 2022.  In the meantime, Medtronic recommends remote surveillance for these patients along with device reprogramming, if necessary.

To look up your device by product name, model or serial number to see whether it is impacted, click here.

NOTE:  You can find the name, model and serial number of your device on the plastic identification card provided to you at the time of your implant.

Medtronic picture of database issue

The box in the upper right corner labeled “Customer Communications For This Model” will tell you if there are any advisories for your device.  If this particular recall affects your device, you will see the same advisory which is circled in red in the photo below.

Patients are advised to continue routine follow ups and use the Care Link Monitoring System.

And, as always, you can call Medtronic Patient Services with any questions at: (800) 551-5544

(M – F, 8am – 5pm Central).

Gene Therapy – Is HCM Cure Possible?

A team of international genetic researchers has just won “The Big Beat Challenge” – a grant from the British Heart Foundation of £30 million ($36 million) payable over a 5 years period to study potentially curative gene therapies to treat genetic cardiomyopathies.

Continue reading “Gene Therapy – Is HCM Cure Possible?”

A Professional HCM Society is Born

Social media erupted this week with exciting news for the HCM community  A new professional society specifically devoted to the study and treatment of hypertrophic cardiomyopathy has been launched. The name is the HCM Medical Society and its new website can be found here.

Founding members of the Board of Directors include many of the top HCM clinicians and researchers from around the world.

The HCM Society will focus on “clinical excellence, research and education” and will hold its inaugural meeting on Friday, September 30 in Washington D.C.

This is wonderful news for HCM patients, and HCMBeat hopes to have more about the future plans for HCM Society in the coming weeks.

Mavacamten vs. Septal Reduction – VALOR-HCM Trial Results Published

The VALOR-HCM trial results have just been published in the Journal of the American College of Cardiology. 

This study enrolled 112 obstructive HCM patients for a 16 week double blind trial of the drug mavacamten (brand name Camzyos). All patients in the trial had been referred for septal reduction therapy – either septal myectomy or septal alcohol ablation – to treat their highly symptomatic obstructive hypertrophic cardiomyopathy.   The researchers looked at whether the addition of mavacamten to their other drugs would improve their symptoms enough so that they no longer met the criteria for septal reduction therapy (SRT) under the 2011 ACC/AHA Guidelines.

You can read many more details about the VALOR-HCM study here in this recent blog post on HCMBeat.

Continue reading “Mavacamten vs. Septal Reduction – VALOR-HCM Trial Results Published”

Recommendations for HCM Depart from 2020 ACC/AHA Guidelines

A recent article by several noted HCM experts shares their recommendations for the screening and evaluation of patients with HCM using several scenarios commonly encountered in clinical practice. Notably, this paper makes several recommendations which differ from the 2020 ACC/AHA Guidelines for the Diagnosis and Treatment of Patients with Hypertrophic Cardiomyopathy (2020 Guidelines).

In particular, the article recommends:

  • Cardiac MRI with contrast upon initial evaluation, and every 3 – 5 years thereafter.  (The 2020 Guidelines recommend Cardiac MRI in certain situations, but not for all patients)
  • Genetic testing only in cases where a pathogenic or likely pathogenic mutation has been identified in a family member and in limited other circumstances (the 2020 Guidelines recommends genetic testing for all as part of the initial assessment)
  • Screening of family members 12 or older only (the 2020 Guidelines recommend screening of children of any age when genetic HCM is diagnosed in a family member and no later than puberty, in any event)
  • That HCM patients be disqualified from competitive sports. (The 2020 guidelines instead recommend a shared decision making approach).

Continue reading “Recommendations for HCM Depart from 2020 ACC/AHA Guidelines”

Aficamten Updates from Cytokinetics

At two recent meetings, South San Francisco biotech company Cytokinetics presented encouraging data on its experimental drug for hypertrophic cardiomyopathy, aficamten (formerly known as CYK-274). 

Continue reading “Aficamten Updates from Cytokinetics”

Increased COVID Risk for HCM Patients

A recent retrospective study of HCM patients with COVID-19 concluded that HCM patients are at increased risk of hospitalization and death from a COVID-19 infection. 

Continue reading “Increased COVID Risk for HCM Patients”

More on Aficamten & Mavacamten from ACC 2022

In addition to the presentation of the results of the VALOR-HCM study which compared mavacamten to septal reduction techniques, covered here in its own HCMBeat blog entry, ACC 2022 featured two other presentations about the new class of drugs known as myosin inhibitors, such as Bristol Myers Squibb’s mavacamten and Cytokinetics’ aficamten.

Continue reading “More on Aficamten & Mavacamten from ACC 2022”

VALOR-HCM Trial – Mavacamten vs. Septal Reduction Therapy – RESULTS ARE IN!

The Phase 3 VALOR-HCM trial results were presented this morning at the American College of Cardiology annual meeting in Washington, DC by the principal investigator, Dr. Milind Desai of the Cleveland Clinic, and the results are good!

What was the VALOR-HCM study?

15 – 20  million people worldwide are estimated to have HCM, with 2/3 of this group having the obstructive form which can cause severe symptoms. Historically, these patients have been treated with medications approved for other conditions, and if those don’t relieve symptoms, they are referred on for septal reduction therapies (SRT) like alcohol septal ablation (a catheter based procedure) or septal myectomy (open heart surgery), which are invasive therapies requiring specialized care and which are not widely available.

The VALOR study was designed to compare mavacamten head to head with SRT to see if mavacamten could be a non-invasive treatment alternative for obstructive HCM.

Continue reading “VALOR-HCM Trial – Mavacamten vs. Septal Reduction Therapy – RESULTS ARE IN!”