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). 

Results from the REDWOOD-HCM open label extension study were presented as a Late Breaking Presentation at the European Society of Cardiology Heart Failure Congress. These results showed that after 6 months of treatment with aficamten, patients improved by one or more New York Heart Association class, with a corresponding improvement in symptoms. Additionally, there were significant reductions seen in left ventricular outflow tract gradients.  According to the presentation, the drug is safe and well tolerated, and only a small decreases in left ventricular ejection fraction was seen in a small number of trial participants. Improvements were also seen in cardiac biomarkers NTpro-BNP and troponin, which are measured via blood test.

Also, data was presented at the American Society of Echocardiography 33rd Annual Scientific Sessions which showed that after 10 weeks of treatment with aficamten, a significant reduction in left atrial volume index was noted, as well as a what appeared to be a lessening of left ventricular hypertrophy.  Improvements in ventricular relaxation and filling, as well as in mitral valve dynamics were also observed.

If you would like to learn more about aficamten, here are some past entries on HCMBeat:

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

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.

 

HCM Clinical Trials – the Latest News

NEWS FROM MYOKARDIA

MyoKardia recently announced a new clinical trial of its drug, mavacamten (formerly known as MYK-461) which will compare the clinical results of mavacamten with septal reduction therapies currently used in clinical practice, i.e. the open heart surgical procedure known as septal myectomy and the catheter based procedure known as alcohol septal ablation.

The study will be run by the Cleveland Clinic with Dr. Milind Desai serving as principal investigator.  MyoKardia expect to begin enrolling patients in early 2020.

Read the press release here.

 

NEWS FROM CYTOKINETICS:

Cytokinetics released positive data from its Phase 1 study of the drug currently known as CK-274 in a poster session at the HFSA 23rd Annual Scientific Meeting in Philadelphia.  The study found that CK-274 was safe and well tolerated, while no serious adverse events or negative changes to vital signs, ECGs or laboratory tests were observed.

The company will now be moving into a Phase 2 clinical trial of CK-274 in patients with obstructive hypertrophic cardiomyopathy, expected to begin in late 2019.

Read their press release here.

 

 

DISCLOSURES:  HCMBEAT HAS RECEIVED PAST UNRESTRICTED EDUCATIONAL GRANTS FROM MYOKARDIA.  ADDITIONALLY, CYNTHIA BURSTEIN WALDMAN OF HCMBEAT SERVES AS A PATIENT ADVISOR ON THE STEERING COMMITTEE FOR MYOKARDIA’S EXPLORER TRIAL.