US-based biopharmaceutical company Alnylam Pharmaceuticals has begun a Phase I/II clinical trial of ALN-HBV to treat patients with chronic hepatitis B virus (HBV) infection.
ALN-HBV is an investigational RNAi therapeutic administered subcutaneously.
The randomised, single-blind, placebo-controlled Phase I/II trial of ALN-HBV is being conducted in three sequential parts.
Part A is a single-dose study designed to involve up to 24 normal healthy volunteers (NHVs).
Part B is a single-dose study planning to include up to a total of 28 patients with chronic HBV infection, while Part C will be a multi-dose study designed to enrol up to 48 patients with chronic HBV infection.
The trial is primarily focused on evaluating the safety and tolerability of ALN-HBV when administered subcutaneously in single and multiple subcutaneous doses.
The secondary objectives of the trial will entail assessment of pharmacokinetics profile and clinical antiviral activity for ALN-HBV, as measured by its effects on serum HBsAg levels in hepatitis B envelope antigen (HBeAg) positive and negative chronic HBV patients.
Alnylam hepatic infectious disease strategic therapeutic area (STAr) programme leader entrepreneur-in-residence vice-president Laura Sepp-Lorenzino said: "We believe ALN-HBV has the potential to become a best-in-class, once-monthly, subcutaneous treatment regimen for the treatment of chronic HBV infection, including patients with both HBeAg-positive and HBeAg-negative disease.
"We are encouraged by the pre-clinical results with ALN-HBV demonstrating potent and durable knockdown of plasma HBV surface antigen (HBsAg) in rodent models of HBV infection.
"High unmet need remains for safe and effective HBV therapies with the potential to produce functional cures after a finite treatment period."
ALN-HBV operates on the company's enhanced stabilisation chemistry (ESC)-GalNAc-siRNA conjugate delivery platform, which facilitates potency and durability with a very wide therapeutic index.
Previous studies conducted on rodent HBV models have displayed that the subcutaneous administration of ALN-HBV is effective with lasting duration and has also demonstrated tolerability after administration.