NEW YORK (GenomeWeb) – Tekmira Pharmaceuticals announced this week that it has initiated a Phase I trial of its RNAi-based hepatitis B therapy TKM-HBV, a key milestone for the company as it prepares to merge with HBV drug firm OnCore BioPharma.
TKM-HBV comprises siRNAs targeting several sites on the HBV genome and is delivered using Tekmira's lipid nanoparticles (LNPs). In preclinical testing, the drug has been shown to trigger reductions in HBV surface antigen, a key indicator of active infection, as well as cccDNA.
According to Tekmira, the 40-subject study will examine single ascending doses of two formulations of the drug in healthy adults. For each formulation, there are five planned cohorts for a total of 20 subjects. Four subjects will be enrolled per cohort with three subjects receiving TKM-HBV, and one receiving placebo.
"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," Tekmira CEO Mark Murray said in a statement. "We expect the results to determine which product formulation we will advance into chronically infected patients later this year."
While Tekmira has a variety of different RNAi drugs under development, TKM-HBV has become its most important following the company's announcement that it would merge with OnCore later this year to become an HBV-focused company.
After the transaction is completed, Tekmira expects to have two HBV drugs, including TKM-HBV, in human testing this year, with multiple others entering the clinic in 2016. The deal was valued at $750 million.