Tekmira Pharmaceuticals Corp. ( TKMR ) presented encouraging preclinical data on its hepatitis B infection candidate, TKM-HBV, at the annual meeting of the Oligonucleotide Therapeutics Society. The company said that TKM-HBV demonstrated potent and rapid reduction in hepatitis B surface antigen in several preclinical models.
Tekmira is developing the candidate for the treatment of chronic hepatitis B infection and expects to file an Investigational New Drug application by the end of this year. The company plans to initiate a phase I study on TKM-HBV in early 2015.
As per company sources, approximately 350 million people are infected with hepatitis B virus (HBV) worldwide. In the U.S. alone there are approximately 1.4 million HBV chronically infected people. Several patients are not adequately treated using currently available treatments. Tekmira aims to address this unmet need with TKM-HBV.
Tekmira was in the news earlier this year when the FDA confirmed that it has modified the full clinical hold on the company's Ebola candidate, TKM-Ebola, to a partial clinical hold. The move allows the potential use of TKM-Ebola in patients who have a confirmed Ebola infection and individuals with suspected of being infected with the disease. The WHO has declared the Ebola epidemic a public health emergency of international concern. The current outbreak of the disease in Africa has claimed several lives.
We remind investors that in Jul 2014, the FDA had placed Tekmira's phase I study on the Ebola candidate on clinical hold due to safety concerns.
Tekmira carries a Zacks Rank #3 (Hold). Some better-ranked biotech stocks include Ligand Pharmaceuticals Inc. ( LGND ), Medivation Inc. ( MDVN ) and Auxilium Pharmaceuticals, Inc. ( AUXL ). While Ligand and Medivation are Zacks Rank #1 (Strong Buy) stocks, Auxilium holds a Zacks Rank #2 (Buy).