Tag: redwood-hcm

Cytokinetics Teases Upcoming Phase 3 Aficamten Trial in nHCM

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A Phase 3 clinical trial aimed at the non-obstructed HCM population (nHCM) appears to be planned for Cytokinetics’ next-generation myosin inhibitor, aficamten.

Based on positive data from Cohort 4 of the Phase 2 REDWOOD-HCM trial, Cytokinetics is planning to soon launch a Phase 3 clinical trial for non-obstructed hypertrophic cardiomyopathy.  Non-obstructed HCM patients are a group whose only current treatment options are diuretics, beta-blockers, and other drugs used in the traditional heart failure setting.  In extreme cases, heart transplantation may be the only path available to these patients.

According to data presented on Sunday at the American College of Cardiology 72nd Annual Scientific Sessions (held in my beloved hometown of New Orleans, the city with the best and least heart-healthy food in the world), 41 patients with nHCM in the cohort showed improvement to both their NT-proBNP and troponin levels (both are biomarkers of heart wall stress seen in blood tests). And, the drug was generally well tolerated.

Separately, data was presented showing that obstructed HCM (HOCM) patients who took aficamten for a 48 week period showed significant improvement to their left ventricular outflow tract gradients (LVOT) while 88% of patients experienced improvement of at least one NYHA Functional Class.

All 19 HOCM patients enrolled in the trial who fit the eligibility criteria for septal reduction therapy (septal myectomy or septal alcohol ablation) at the start of the trial improved so much that they were no longer eligible after 48 weeks on aficamten.

It would be wonderful to have better options for the treatment HCM, so here’s hoping that aficamten continues down the road to FDA approval.

For more about aficamten, read these prior posts from HCMBeat:

2 Companies Testing Drugs for HCM

HCM Clinical Trials – the Latest News

The Future of HCM Care

Positive Signs from REDWOOD-HCM

Promising Data about Aficamten Presented at Meetings

More on Aficamten & Mavacamten from ACC 2022

Aficamten Updates from Cytokinetics

Aficamten Gets “Breakthrough Drug” Status from FDA

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

Results Published from REDWOOD-HCM Phase 2 Trial

The Future of HCM Treatment

Results Published from REDWOOD-HCM Phase 2 Trial

Published on by hcmbeat2 Comments

Results from Cytokinetics’ REDWOOD-HCM Phase 2 clinical trial of the experimental drug aficamten were just published in the Journal of the American College of Cardiology. 

Aficamten, a second generation myosin inhibitor, was administered to a small group of 28 patients as part of a phase 2 trial to determine safety of the drug of the drug in obstructive HCM over a 10 week period. 

No safety issues were found, while most trial participants experienced substantial reductions in left ventricular outflow tract gradients. Study participants also reported improvement to their symptoms, while blood tests showed improvement to certain biomarkers of heart stress.   

You can read more about the drug aficamten and Cytokinetics, the company behind it, in the below posts on HCMBeat. Next for aficamten is the Phase 3 trial entitled SEQUOIA-HCM.

Promising Data about Aficamten Presented at Meetings

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

The Future of HCM Treatment

Published on by hcmbeat4 Comments

Doctors from the University of Pennsylvania this week published an overview of current therapies available for the treatment of HCM.  While this article mentions all of the old standards – beta blockers, calcium channel blockers, myectomy and alcohol ablation, the real focus is on the future of HCM treatment. In particular, the article describes several new and/or experimental therapies which look promising for the future.

Continue reading “The Future of HCM Treatment” →

Promising Data about Aficamten Presented at Meetings

Published on by hcmbeat4 Comments

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

Continue reading “Promising Data about Aficamten Presented at Meetings” →

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

Published on by hcmbeat6 Comments

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

Published on by hcmbeat6 Comments

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

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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

Published on by hcmbeat6 Comments

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.

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

Published on by hcmbeat9 Comments

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.