Back to top

Alnylam, Vir Begin Phase I/II Study on Hepatitis B Candidate

Read MoreHide Full Article

Alnylam Pharmaceuticals, Inc. (ALNY - Free Report) announced that licensee Vir Biotechnology, Inc. has initiated a phase I/II study evaluating VIR-2218 for the treatment of chronic hepatitis B virus (HBV) infection. VIR-2218 is a novel, investigational RNA interference (RNAi) therapeutic that is administered via subcutaneous injection and designed to effectively silence all HBV RNA transcripts, which are necessary for viral replication and viral protein expression.

VIR-2218 was originated by Alnylam as ALN-HBV02 and it was out-licensed to Vir. The latter will conduct the clinical development of the candidate. VIR-2218 is the first product to enter clinical trials as part of the research collaboration between Vir and Alnylam, announced in 2017, to develop novel RNAi therapeutics for infectious diseases.

The phase I/II trial of VIR-2218 is a randomized, placebo-controlled study designed to assess the safety, tolerability, pharmacokinetics and antiviral activity of the candidate in healthy volunteers and patients with chronic HBV infection. The companies plan to enroll patients at multiple study sites in several countries around the Pacific Rim. The trial will progress in a staggered, parallel fashion to rapidly generate early proof of concept data.

The company expects data from the study in 2019.

Share price of Alnylam declined 38.3% year to date compared with the industry’s decline of 17.7%.

 

We note that, Anlylam is focused on the development of novel therapeutics based on RNAi. In August 2018, the FDA approved Alnylam’s Onpattro (patisiran) lipid complex injection, a first-of-its-kind RNAi therapeutic, for the treatment of the polyneuropathy of hereditary transthyretin-mediated (hATTR) amyloidosis in adults. Onpattro is the first and only FDA-approved treatment for this indication.

The company’s Advanced ALN-TTRsc02 is a subcutaneously administered investigational RNAi therapeutic in development for the treatment of ATTR amyloidosis. The company reached alignment with the FDA on a pivotal phase III study for ALN-TTRsc02 in patients with hATTR amyloidosis.

 

Zacks Rank & Stocks to Consider

Alnylam is a Zacks Rank #4 (Sell) stock.

Some better-ranked stocks worth considering are Bristol-Myers Squibb Company (BMY - Free Report) , Gilead Sciences Inc. (GILD - Free Report) and Merck & Co. (MRK - Free Report) . While Bristol-Myers and Gilead sport a Zacks Rank #1 (Strong Buy), Merck carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Bristol-Myers’ earnings per share estimates have increased from $3.62 to $3.87 for 2018 and from $3.82 to $4.08 for 2019 over the past 60 days. The company delivered a positive earnings surprise in all of the trailing four quarters with average of 11.99%.

Gilead’s earnings per share estimates have increased from $6.60 to $6.93 for 2018 and from $6.53 to $6.83 for 2019 over the past 60 days. The company delivered a positive earnings surprise in three of the trailing four quarters with average of 6.99%.

Merck’s earnings per share estimates have increased from $4.27 to $4.34 for 2018 and from $4.63 to $4.71 for 2019 over the past 60 days. The company delivered a positive earnings surprise in all of the trailing four quarters with average of 3.96%. Shares of the company have increased 37.2% year to date.

The Hottest Tech Mega-Trend of All

Last year, it generated $8 billion in global revenues. By 2020, it's predicted to blast through the roof to $47 billion. Famed investor Mark Cuban says it will produce "the world's first trillionaires," but that should still leave plenty of money for regular investors who make the right trades early.

See Zacks' 3 Best Stocks to Play This Trend >>



More from Zacks Analyst Blog

You May Like

Published in