Alnylam Pharmaceuticals, Inc. (ALNY - Free Report) announced that it has dosed the first patient in the phase I study of ALN-AGT, an investigational RNAi therapeutic targeting angiotensinogen (AGT) for the treatment of hypertension. The patient population included patients with resistant or refractory hypertension, chronic kidney disease or heart failure. The company expects to report initial results in late 2019.
The phase I study is a placebo-controlled study designed to evaluate the safety, tolerability, pharmacokinetic and pharmacodynamic effects of subcutaneously administered ALN-AGT in patients with essential hypertension. The study will be conducted in four parts.
Shares of the company have lost 5.5% compared with the industry’s decline of 1.7%.
About 47% of United States’ adults live with hypertension, with more than half of patients on medication remaining above the blood pressure target level. In March 2019, the company submitted a clinical trial authorization (CTA) application to The Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom to initiate a phase I study of ALN-AGT. On receiving the MHRA approval, the company plans to initiate the phase I study in mid 2019.
Alnylam has several other RNAi candidates in its pipeline. However, the company’s first FDA-approved RNAi therapeutic is Onpattro (patisiran) lipid complex injection, available in the United States for the treatment of the polyneuropathy of hereditary transthyretin-mediated (hATTR) amyloidosis in adults. In the EU, Onpattro is approved for the treatment of hATTR amyloidosis in adults with stage 1 or stage 2 polyneuropathy.
Alnylam has several candidates in development stages. In October 2018, the company submitted a CTA application for ALN-AAT02, an investigational RNAi therapeutic, for the treatment of alpha-1 antitrypsin deficiency-associated liver disease (alpha-1 liver disease). Alnylam announced that it has initiated a phase I study of ALN-AAT02, with initial results expected in 2019.
The company is also evaluating inclisiran along with The Medicines Company (MDCO - Free Report) in phase III ORION studies for hypercholesterolemia. The company expects to file an NDA in the United States at or around 2019-end, assuming positive phase III results.
Zacks Rank & Stocks to Consider
Alnylam currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the biotech sector are Anika Therapeutics Inc. (ANIK - Free Report) and Applied Genetics Technologies Corp. (AGTC - Free Report) . Both of them carry a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Anika’s earnings per share estimates have moved up from $1.22 to $1.28 for 2019 and from $1.21 to $1.33 for 2020 in the past 60 days. The company delivered a positive earnings surprise in the trailing four quarters, with average beat of 72.00%.
Applied Genetics’ loss per share estimates have narrowed from $1.25 to 1 cent for 2019 and from $2.39 to $2.15 for 2020 in the past 60 days. The company delivered a positive earnings surprise in three of the trailing four quarters, with average beat of 83.47%.
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