HUYABIO International has dosed the first three subjects in the ongoing Phase II HBI-3000-402 clinical trial of its new drug for pharmacological 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.
The preclinical and clinical pharmacology of HBI-3000 supports its potential use to reinstate sinus rhythm in AF.
In preclinical testing, HBI-3000 showed a reduced risk for proarrhythmia.
The Phase II two-stage, serial cohort dose-escalation and expansion trial is assessing the pharmacological cardioversion of acute AF.
It will evaluate a single intravenous dose of HBI-3000 in AF patients between two and 72 hours.
Cardioversion is intended to restore a normal heart rate and rhythm in patients with AF and is usually done using high-energy electrical shock.
HUYABIO International president, CEO and executive chair Dr Mireille Gillings said: “We are excited to proceed with dosing AF patients in our Phase II trial of HBI-3000.
“AF is a growing global problem and HUYABIO’s drug is well-positioned to provide a new pharmacological treatment for patients, many of whom would otherwise get electrically cardioverted which can be both stressful and painful.”
There is a substantial need for safer pharmacological interventions for the treatment of AF, as the existing standard of care therapies pose poor safety and efficacy profiles.
Furthermore, electrical cardioversion, an alternative for cardioversion, needs fasting and sedation.
Last month, the company concluded the Phase I trial of HBI-3000 and obtained clearance from the US Food and Drug Administration to progress with dose escalation in the Phase II trial.