HUYABIO INTERNATIONAL ANNOUNCES COMPLETION OF HBI-3000 PHASE 1 TRIAL AND FDA APPROVAL TO PROCEED WITH DOSE ESCALATION IN PHASE 2

Phase 1 trial evaluated the pharmacokinetics and safety of HBI-3000 when dosed with the
strong CYP2D6 inhibitor, paroxetine

SAN DIEGO, May 17, 2022 /PRNewswire/ -- HUYABIO International, the leader in accelerating global development of China's pharmaceutical innovations, today announced the successful completion of a Phase 1 drug-drug interaction clinical trial of HBI-3000, a novel drug for cardioversion of atrial fibrillation (AF).

Dr. Mireille Gillings, President, CEO & Executive Chair, said, "I am pleased to announce this positive step in the development of HBI-3000 for potential use in patients suffering from AF, a serious condition that affects more than 30 million people worldwide. There is a pressing need for safer and more effective pharmacological interventions to treat this condition. The successful completion of this Phase 1 trial will enable progression of the ongoing Phase 2 trial investigating efficacy of HBI-3000 for the conversion of acute AF."

Based on the preliminary safety and pharmacokinetic data, the US Food and Drug Association approved dose escalation in the HBI-3000-402 study which is evaluating pharmacological cardioversion of acute AF (NCT04680026). Cardioversion aims to restore a normal heart rate and rhythm in AF patients and is often done by high energy electrical shock.

"This Phase 1 study evaluated HBI-3000 pharmacokinetics in the presence of a strong CYP2D6 inhibitor, paroxetine," said Jay Mason MD, University of Utah. "The data demonstrate lack of significant PK interaction between paroxetine and HBI-3000 and support dose escalation in the ongoing HBI-3000-402 Phase 2 study, without the need to prescreen for CYP2D6 genetic polymorphism or exclude concomitant medications that are CYP2D6 inhibitors."

About HBI-3000
HBI-3000 is a multi-ion channel blocker with in vitro inhibitory effects on I_Na-Peak, I_Na-Late, I_{Ca, L} and I_Kr being developed by HUYABIO International for the conversion of recent onset atrial fibrillation. The drug's preclinical and clinical pharmacology supports the potential of HBI-3000 to restore sinus rhythm in Atrial Fibrillation. The drug has demonstrated a low risk for proarrhythmia in preclinical testing. Data from the first in human Phase 1 trial of the IV formulation were presented during a poster session at the American Heart Association 2019 annual meeting. A copy is available via HUYABIO's website at www.huyabio.com. Information on the ongoing Phase 2 acute Atrial Fibrillation trial, HBI-3000-402, can be found at https://clinicaltrials.gov/ct2/show/NCT04680026.

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, 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.

Contact Details:
Yiota Merianos
Corporate Communications
+1.858.353.1217
ymerian[email protected]

SOURCE HUYABIO International