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
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."
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