Alnylam announces phase 1/2 clinical trial of ALN-HBV RNA therapeutic

Alnylam Pharmaceuticals Inc. announced the initiation of its phase 1/2 clinical trial with ALN-HBV, a subcutaneously administered investigational RNA-interference therapeutic for the treatment of chronic hepatitis B virus infection.

The trial will first be conducted on healthy volunteers, then in patients with chronic hepatitis B virus. It is based on encouraging pre-clinical data presented at the American Association for the Study of Liver Disease annual meeting in November 2015. These data showed that subcutaneous administration of ALN-HBV led to knockout of hepatitis B surface antigen in rodent hepatitis B virus models.

“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,” Laura Sepp-Lorenzino, PhD, vice president, Entrepreneur-in-Residence, and program leader for Alnylam’s Hepatic Infectious Disease Strategic Therapeutic Area (STAr), said in a press release.

The phase 1/2 trial of ALN-HBV is a randomized, single blind, placebo-controlled study conducted in three sequential parts. Part A is a single-dose study designed to examine up to 24 healthy volunteers. Part B will be a single-dose study composed of up to 28 patients with chronic HBV infection. Part C will be a multi-dose study comprising up to 48 patients with chronic HBV infection.

The primary objective of the trial is to evaluate the safety and tolerability of single and multiple subcutaneous doses of ALN-HBV. Secondary objectives include the evaluation of pharmacokinetics and clinical antiviral activity for the treatment.