First patient dosed in trial investigating cardioversion of recent-onset atrial fibrillation
San Diego, CA, USA – November 2, 2021 – HUYABIO International (HUYABIO), the leader in accelerating global development of China’s pharmaceutical innovations, today announced that the first patient has been dosed in a Phase 2 study of HUYABIO’s novel drug for cardioversion of atrial fibrillation (AF) at Wellington Regional Hospital in Wellington, New Zealand. Cardioversion aims to restore a normal heart rate and rhythm in AF patients and is often done by high energy electrical shock.
Denis Roy, MD, Montreal Heart Institute and Chief Investigator of the trial, said, “This Phase 2 study will investigate the ability of HUYABIO’s candidate drug to safely pharmacologically convert patients with recent onset AF back into a normal rhythm. This follows a successful Phase 1 study in the United Kingdom, where this drug was well tolerated, with no dose limiting adverse events or arrhythmias observed.”
The Phase 2 trial, is a two-stage, serial cohort dose escalation and expansion study of a single intravenous infusion of HBI-3000 in patients with AF between 2 and 72 hours (NCT04680026) and aims to recruit 150 patients across North America and the Asia-Pacific region. Several public hospitals in New Zealand are now recruiting under approval by the country’s Medicines and Medical Devices Safety Authority, Medsafe and US sites will be initiating under a US IND. HUYABIO’s anti-arrhythmic is a multi-ion channel blocker with in vitro inhibitory effects on INa-Peak, INa-Late, ICa, L and IKr (as well as Ito and IKur) being developed for the cardioversion of recent onset AF. AF is a serious condition that affects more than 3.5 million patients in the US and 30 million worldwide. There is a significant need for safer and more effective pharmacological interventions to treat AF, as the current standard of care treatments have poor safety and efficacy profiles and the alternative, electrical cardioversion, requires fasting and sedation and can be anxiety provoking for patients.
“This is another encouraging milestone in HUYABIO’s development of a potentially new and improved treatment for patients with AF,” Dr. Mireille Gillings, CEO & Executive Chair of HUYABIO, stated. “This new drug candidate will provide important treatment options for patients with high unmet medical need. The innovative two-stage design of our Phase 2 study will allow us an early look at potential efficacy and deliver placebo-controlled proof of concept data as well.”
About HUYABIO’s Anti-arrhythmic Program
HUYABIO’s HBI-3000 program consists of small molecule sulcardine derivatives which are multi-ion channel blockers with in vitro inhibitory effects on INa-Peak, INa-Late, ICa, L and IKr being developed by HUYABIO International for the conversion of atrial fibrillation (AF). The drug’s preclinical and clinical pharmacology supports the potential of the drug to restore sinus rhythm in AF. The drug has demonstrated a low risk for proarrhythmia in preclinical testing. Phase 1 data was presented during a poster session at the American Heart Association 2019 annual meeting. The poster is available via the HUYABIO website at www.huyabio.com.
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 the global markets. Through extensive collaboration with biopharmaceutical, academic and commercial organizations, it has built the largest China-sourced compound portfolio covering all therapeutic areas. Hiyasta® the company’s first commercial product is marketed in Japan. With offices in the US, Japan, South Korea, Canada, Ireland 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, please visit www.huyabio.com.
Bob Goodenow, PhD