HUYABIO INTL. PRESENTS POSITIVE CLINICAL RESULTS FROM HBI-3000 PHASE 2A CLINICAL TRIAL OF NOVEL MULTI-ION CHANNEL BLOCKER FOR ACUTE ATRIAL FIBRILLATION

24.04.25 20:15 Uhr

Authors: Denis Roy1, Suzanne Romano2, Jay W. Mason3, Monica Wynn2, Charles Pollack4, Gary Elliot5, Mireille Gillings2, Jerome B. Riebman2

SAN DIEGO, April 24, 2025 /PRNewswire/ -- HUYABIO International today announced the presentation of new patient data for HBI-3000, a novel bioinspired investigational drug with promising antiarrhythmic properties, excellent tolerability and a unique mechanism limiting QT prolongation and risk of inducing lethal arrhythmias.

Initial clinical safety and efficacy results for HBI-3000 will be highlighted in a poster presentation at the Heart Rhythm Annual Meeting to be held April 24 – 27 in San Diego, CA.  

Dr. Mireille Gillings, President, CEO & Executive Chair at HUYABIO, said, "Patients with atrial fibrillation (AF) and their clinicians are faced with limited treatment options. HBI-3000 has strong potential to transform rhythm control treatment, meeting the urgent need for safer and more effective therapies for AF."

Although many available antiarrhythmic drugs (AADs) effectively manage arrhythmias, they can also carry severe risks that include fatal arrhythmias and sudden death. Sulcardine, the active ingredient in HBI-3000 and HBI-3020 (a derivative new salt of HBI-3000), has been designed to address these challenges by reducing the likelihood of life-threatening arrhythmias, a serious and potentially fatal drawback of current treatment options, while maintaining the activity required for efficacy.

The Heart Rhythm Annual Meeting presentation will highlight results from the HBI-3000-402 trial of sulcardine given as an IV infusion of HBI-3000. The drug was well-tolerated in acute-onset AF patients and demonstrated a clinically meaningful therapeutic effect.

Dr. Denis Roy, lead investigator on the HBI-3000 Phase 2 trial and abstract author, said, "Very promising results from this phase 2 clinical trial showed that IV HBI-3000, an investigational multichannel blocker, was effective and well tolerated for the conversion of AF. There is an important need for a more effective and safer antiarrhythmic drug for the acute management of AF."

Meeting the Unmet Need for Innovative AF Therapies

Atrial fibrillation is a serious cardiovascular condition that is highly prevalent in the United States and continues to grow with the aging population. Many AADs carry risks of serious side effects, including proarrhythmia, QT prolongation, and sudden death. Thus, there is a high unmet need for safe and efficacious AADs.

The poster presentation, titled "Safety and Efficacy Of HBI-3000, An Investigational Multichannel Blocker for Patients with Non-Permanent Atrial Fibrillation: Initial Clinical Findings", will be presented April 27th, 2025, from 09:00 AM to 11:00 AM during the PO-511253 Poster Session VII.  The presentation, led by Dr. Denis Roy, will focus on the safety and efficacy of a single 30-minute IV infusion of HBI-3000 to convert AF to SR in the hospital setting.

About HUYABIO International

HUYABIO is the leader in accelerating the global development of novel biopharmaceutical product opportunities originating in China enabling faster, more cost-effective and lower- risk drug development in global markets. Through extensive collaboration with biopharmaceutical, academic and commercial organizations, it has built the largest China- sourced compound portfolio covering all therapeutic areas. With offices in the US, Japan, Europe, and eight strategic locations across China, the company has become a partner of choice to accelerate product development and maximize value globally.

For more information, visit www.huyabio.com.

(1) Montreal Heart Institute, University of Montreal, Montreal, QC, Canada; (2) HUYABIO International, San Diego, CA, USA; (3) Cardiology Division, University of Utah, Salt Lake City, UT, USA; (4) Department of Emergency Medicine, University of Mississippi Medical Center, Jackson, MS, USA ; (5) Galenic Strategies, Evergreen CO, USA

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SOURCE HUYABIO International