Alnylam (ALNY) Begins Phase I/II Study On Chronic HBV Drug

Alnylam Pharmaceuticals, Inc. (NASDAQ:ALNY) announced that it has initiated a phase I/II study on one of its pipeline candidates, ALN-HBV, which is a subcutaneously administered experimental RNAi therapeutic for the treatment of chronic hepatitis B virus (HBV) infection.

The randomized, single-blind, placebo-controlled study is being conducted in three sequential parts. It will be initially conducted in normal healthy volunteers and then in chronic HBV patients. The primary objective of the study is to evaluate the safety and tolerability of single and multiple subcutaneous doses of ALN-HBV. The company expects to report initial data from the study in mid-2017.

We note that ALN-HBV is being developed utilizing the company's enhanced stabilization chemistry-GalNAc-siRNA conjugate delivery platform.

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We are encouraged by the company’s progress with the candidate. Per the company’s press release, 2 billion people are infected with HBV across the world and 400 million people have become chronically infected. In the U.S. alone there are 1 to 2 million people chronically infected with HBV. Moreover, an estimated 1 million people die each year from HBV and its complications worldwide.

Considering that there exists a significant unmet need for drugs targeting chronically infected HBV patients, if developed successfully, ALN-HBV could gain an opportunity to cater to a large market.

Meanwhile, Alnylam has made substantial progress with its RNAi therapeutics pipeline. Presently, the two most advanced candidates at Alnylam are patisiran (phase III – familial amyloidotic polyneuropathy) and revusiran (phase III – familial amyloidotic cardiomyopathy). While Alnylam expects to report data from the APOLLO study on patisiran in mid-2017, data readout from the ENDEAVOUR study on revusiran is anticipated in early 2018.

Alnylam is a Zacks Rank #3 (Hold) stock. Some better-ranked stocks in the healthcare sector include Innoviva, Inc. (NASDAQ:INVA) , Bristol-Myers Squibb Company (NYSE:BMY) and Pfizer Inc. (NYSE:PFE) . While Innoviva sports a Zacks Rank #1 (Strong Buy), Bristol-Myers and Pfizer carry a Zacks Rank #2 (Buy).