US-based biopharmaceutical firm Novira Therapeutics has started a Phase Ia clinical trial of NVR-1221, a small molecule, direct-acting antiviral, for treatment of chronic hepatitis B (HBV) infection.
The trial is designed to evaluate the pharmacokinetic profile and dose-related safety and tolerability of NVR-1221 in around 40 healthy volunteers.
Novira co-founder, president and chief scientific officer Lalo Flores said: "NVR-1221 belongs to a new class of antiviral agents that target the viral core or capsid protein of the hepatitis B virus.
"Achievement of this important milestone positions NVR-1221 to be the first agent to test the curative potential of HBV core inhibitors in the clinic."
The Phase Ia trial follows successful completion of the Clinical Trial Application (CTA) regulatory process in New Zealand.
Following completion and satisfactory outcome of the Phase 1a trial, the company intends to start a Phase 1b clinical trial to test the safety, PK and initial antiviral activity of NVR-1221 in patients with chronic HBV infection.
Novira chief executive officer Christian Schade said the start of the Phase 1a clinical trial marks an important milestone for the company as it moves closer to bringing innovative and potentially curative approaches to patients with chronic HBV infection.
"We look forward to completing this Phase 1a trial over the coming months and commencing a Phase 1b clinical study to test NVR-1221 in chronic HBV patients as mono-therapy and in combination with approved agents," Schade said.
NVR-1221 is indicated for oral administration in patients with chronic hepatitis B (CHB) that inhibits the HBV core or capsid protein.
HBV core is new drug target with multiple activities required for viral replication and persistence.
The company said that inhibition of HBV core protein function by NVR-1221 provides the potential for a more efficient suppression of the virus leading to improved durable viral suppression and cure rates.