Huyabio International has concluded the Phase I drug-drug interaction clinical trial of its drug, HBI-3000, for cardioversion of atrial fibrillation (AF).
A multi-ion channel blocker, HBI-3000 possesses in vitro inhibitory effects on INa-Peak, INa-Late, ICa, L and IKr.
Its preclinical and clinical pharmacology supports the potential for restoring sinus rhythm in AF.
Furthermore, in preclinical testing, HBI-3000 showed a reduced risk for proarrhythmia.
The Phase I trial analysed the safety and pharmacokinetics (PK) of HBI-3000 when administered along with paroxetine, a CYP2D6 inhibitor.
Findings showed that no substantial PK interaction was observed between paroxetine and HBI-3000.
Based on the initial safety and pharmacokinetic data from the Phase I trial, the US Food and Drug Administration granted approval for dose escalation in the Phase II HBI-3000-402 clinical trial.
The two-stage, serial cohort dose-escalation and expansion study will assess a single 30-minute intravenous (IV) infusion of HBI-3000 for the conversion of patients with recent-onset AF.
This trial will analyse the pharmacological cardioversion of acute AF.
Carried out usually using high-energy electrical shock, cardioversion intends to reinstate a normal heart rate and rhythm in AF patients.
Huyabio International president, CEO and executive chair Dr Mireille Gillings 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.
“The successful completion of this Phase I will enable progression of the ongoing Phase II trial investigating efficacy of HBI-3000 for the conversion of acute AF.”