Tekmira Pharmaceuticals Corporation, a leading company in the development of RNA interference (RNAi) therapeutics, recently announced they have successfully dosed the first subject in a Phase I clinical trial of TKM-HBV – a therapeutic drug formulated to decrease hepatitis B surface antigens in patients suffering from chronic hepatitis B virus (HBV) infection.
The Tekmira’s CEO and President, Dr. Mark J. Murray, said in a press release: “We are pleased to have reached this important milestone, initiation of phase I studies with TKM-HBV. Since TKM-HBV represents our most important development program, we are testing two LNP formulations, generations three and four, of the product in this study. We expect the results to determine which product formulation we will advance into chronically infected patients later this year.”
The Phase I clinical trial for TKM-HBV is a single-blind, randomized and placebo-controlled assessment of single and ascending doses of the agent. The study will be evaluating the tolerability, safety and pharmacokinetics of the intravenous administration of two different formulations of the agent in healthy adults. For each of the formulations, there are 5 planned cohorts with a total of 20 subjects (40 subjects in total will be enrolled). Per cohort, 4 subjects will be enrolled, with 3 of them receiving the agent TKM-HBV and the fourth receiving a placebo.
Notes About TKM-HBV
TKM-HBV works to facilitate hepatitis B surface antigen (HBsAg) reduction in patients suffering from a chronic hepatitis B infection. Researchers believe the continued existence of HBsAg in these patients drives disease pathogenesis and impede’s the body’s ability to get rid of the virus.
“Blocking HBsAg may lead to a functional cure by promoting immune-mediated clearance and control of HBV, potentially through HBsAg seroconversion. TKM-HBV is a novel lipid nanoparticle (LNP) formulated RNAi therapy that uniquely targets three highly conserved regions of the HBV viral genome,” as explained in the press release.
By targeting different sites in the HBV genome, there is a reduction in viral antigens, and a wide range of HBV genotypes is rendered susceptible to treatment, ultimately preventing the virus from developing resistance. TKM-HBV’s pre-clinical tests evidenced reductions of HBsAg and of some other important viral markers in the most frequent HBV genotypes, which corroborates the agent’s potential as a treatment for chronic HBV infections.