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

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”

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”

Aficamten Gets “Breakthrough Drug” Status from FDA

Cytokinetics has announced that its experimental drug aficamten, currently in trials as a potential treatment for obstructive hypertrophic cardiomyopathy, has received breakthrough therapy designation from the FDA.  This designation is awarded by the FDA to certain drugs which may offer substantial improvement to patients over available therapies. The designation could shorten the FDA approval process for the drug by about 4 months.

You can read more about Cytokinetics and aficamten in these older posts from HCMBeat: 

Interview with Dr. Martin Maron about Cytokinetic’s Drug Aficamten 

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

Cytokinetics Moves Forward with HCM Drug Trial

Cytokinetics Announces its Phase 2 Clinical Trial

Positive Signs from REDWOOD-HCM

The Future of HCM Care

HCM Clinical Trials – the Latest News

2 Companies Testing Drugs for HCM

Scientists Get $10 Million Grant to Develop HCM Treatments

 

 

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

Editor’s note:  You have probably noticed a distinct uptick in clinical trials of potential treatments for hypertrophic cardiomyopathy.  HCMBeat has been following this trend and has previously published a host of stories about such trials, including this story about the positive results from the REDWOOD-HCM Phase 2 clinical trial, as well as past stories discussing the biopharmaceutical company Cytokinetics, its  drug aficamten (previously known as CK-274), and the REDWOOD-HCM trial.

Some of these earlier stories are as follows: 

2 Companies Testing Drugs for HCM

HCM Clinical Trials – the Latest News

Positive Signs from REDWOOD-HCM

Cytokinetics Moves Forward with HCM Drug Trial

Recently, Cynthia Waldman of HCMBeat had the opportunity to speak over Zoom with Dr. Martin Maron, who recently served as the principal investigator of Cytokinetics’ REDWOOD trial.  The conversation focused both on Cytokinetic’s drug aficamten (previously known as CK-274), and the new class of drugs known as “myosin inhibitors.”  What follows is a transcript of their conversation (which has been edited for readability). 

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

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

Cytokinetics today announced positive topline results for its experimental drug CK-274 from its recent Phase 2 REDWOOD-HCM trial for patients who have obstructive hypertrophic cardiomyopathy (HOCM).

According to the press release, this drug, a next-in-class cardiac myosin inhibitor, showed consistent and meaningful reduction in left ventricular outflow tract gradients in HOCM with its effects evident within 2 weeks of starting the drug. The benefits continued until the end of treatment 10 weeks later. No patients had to  discontinue the drug or take a break from treatment due to reduced left ventricular ejection fraction. And, the drug was well tolerated and appeared to be free from significant side effects.

Cytokinetics plans to commence a Stage 3 for CK-274 trial by the end of 2021. Full results of the Stage 2 REDWOOD study will be presented at an upcoming scientific meeting.

Cytokinetics Moves Forward with HCM Drug Trial

This week Cytokinetics announced that the first patient in Cohort 2 of their REDWOOD-HCM trial has been dosed.

Cytokinetics is testing the safety and tolerability of the cardiac myosin inhibitor CK-274 for the potential treatment of hypertrophic cardiomyopathy.  The trial already enrolled completed enrollment of 18 patients in the first cohort.  Sites are located across North America and Europe and results are expected in the middle of this year.

Separately, Cytokinetics announced that CK-274 has been granted an orphan drug designation by the FDA. This designation confers certain benefits and financial incentives for drugs intended to treat conditions affecting fewer than 200,000 people in the U.S.

Positive Signs from REDWOOD-HCM

Cytokinetics announced this week the progression of REDWOOD-HCM, its ongoing Phase 2 clinical trial of CK-274, a cardiac myosin inhibitor for the treatment of HCM.

According to the press release, preliminary results show substantial reductions in left ventricular outflow tract gradients (LVOT), with only modest decreases in left ventricular ejection fraction. (LVEF). 

Based on this early positive data, the study will continue and will enroll a second group of approximately 18 patients. 

Cytokinetics hopes to have results from REDWOOD-HCM in the middle of 2021, and hopes to begin a Phase 3 trial for CK-274 by the end of 2021.

For detailed information about this trial see ClinicalTrials.gov.

The Future of HCM Care

Dr. Stephen Heitner, together with his colleagues at Oregon Health & Sciences University, published an article last week in the European Journal of Heart Failure which gives a glimpse into the treatment of hypertrophic cardiomyopathy (HCM) in the future.  Although recent publications have stated that the majority of HCM patients today have a favorable prognosis when receiving appropriate treatment, a heavy disease burden continues to be placed upon patients.  Hence, better and more effective treatments for HCM are still needed in order to lessen this burden.

Continue reading “The Future of HCM Care”

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

Cytokinetics today announced that its Phase 2 double-blind study of its experimental drug CK-274 entitled “REDWOOD-HCM” (Randomized Evaluation of Dosing With CK-274 in Obstructive Outflow Disease in HCM (hypertrophic cardiomyopathy) has begun enrollment.  The trial will enroll patients with symptomatic, obstructive HCM.

CK-274 is a next-generation cardiac myosin inhibitor which the company hopes will prove to be beneficial for the treatment of hypertrophic cardiomyopathy (HCM).

There are currently two companies in clinical trials for HCM:  Cytokinetics and MyoKardia. You can read more about their efforts here and here.