Tekmira Pharmaceuticals announced this morning that it has begun the first phase of the clinical trial for its hepatitis B drug TKM-HBV. Shares of Tekmira edged upward by as much as 1% after the news was announced.
Tekmira reveals clinical trial
Although much of the buzz around the drug maker has been over its Ebola virus treatment, today’s announcement focuses on its hepatitis B drug. Several analysts have said in the last several months that investors should actually care more about this drug than about the Ebola treatment because the market for hepatitis B is likely bigger.
In today’s announcement, Tekmira said it has given the first dose to the first subject in the Phase 1 clinical trial of TKM-HBV. The drug maker describes the drug as a “therapeutic agent designed to reduce hepatitis B antigen in patients chronically infected with hepatitis B virus.”
The news comes in the same month as the announcement that Tekmira had reached an agreement to acquire OnCore Biopharma, another key player in hepatitis B treatments. OnCore brings multiple candidate drugs over to Tekmira.
Details on Tekmira’s drug trial
“We are pleased to have reached this important milestone, initiation of phase I studies with TKM-HBV,” said Tekmira President and CEO Dr. Mark Murray in a statement. “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 company described the Phase I clinical trial as a “randomized, single-blind, placebo-controlled study, involving single ascending doses of TKM-HBV.” The goal of the study is to see how safe the drug is and how well patients are able to tolerate it. The drug is given intravenously.
Tekmira reported that 40 “healthy” adults are participating in the study, which covers both of the two formulations they are testing in the clinical trial. Four patients will be in each “cohort,” and three of them will receive the company’s hepatitis B treatment while the fourth will receive a placebo.