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Alnylam Completes Enrollment in Phase III Study of Lumasiran

Zacks Equity Research

Alnylam Pharmaceuticals, Inc. ALNY announced that it has completed enrollment in its phase III study ILLUMINATE-A of lumasiran. Lumasiran is an investigational RNAi therapeutic targeting glycolate oxidase for the treatment of adults and children with primary hyperoxaluria type 1 (PH1). The study enrolled patients across 16 sites in eight countries. The company expects to report top-line results from the study in late 2019. If positive, it expects to submit filings for global regulatory approvals starting early 2020.

Further, the company announced complete final positive results from its phase I/II study and reiterated positive results from its ongoing phase II open-label extension (OLE) study of lumasiran.

In the phase I/II study, lumasiran demonstrated a mean maximal reduction in urinary oxalate of 75% relative to baseline across all cohorts (1 mg/kg monthly, 3 mg/kg monthly, and 3 mg/kg quarterly; N=20). In the study, lumasiran-treated patients across all cohorts (N=20) experienced a mean maximal decrease of 77% in the ratio of urinary oxalate to creatinine, an additional measure of oxalate reduction that addresses the variability, which is inherent in 24-hour urine collections.

All patients (100%), who completed phase I/II, continue dosing in the ongoing phase II OLE phase of the study. As of February 2019, patients in the phase II OLE study have received lumasiran for four months. The drug’s dosing across all evaluable cohorts (N=9) resulted in mean maximal reduction in urinary oxalate of 72% relative to phase I/II baseline levels. 

Shares of the company have lost 2.2% against the industry’s growth of 4.4%.

Alnylam also has other candidates in its pipeline. The company along with partner The Medicine Company MDCO is evaluating inclisiran in phase III ORION studies for hypercholesterolemia.

Alnylam and Regeneron Pharmaceuticals REGN extended their collaboration agreement. Both the companies will work together to discover, develop and commercialize new RNAi therapeutics for a broad range of diseases by addressing disease targets expressed in the eye and central nervous system (CNS), in addition to a select number of targets expressed in the liver.


Alnylam Pharmaceuticals, Inc. Price


Alnylam Pharmaceuticals, Inc. Price

Alnylam Pharmaceuticals, Inc. price | Alnylam Pharmaceuticals, Inc. Quote

Zacks Rank & Stock to Consider

Alnylam currently carries a Zacks Rank #3 (Hold).

A better-ranked stock in the biotech sector is Anika Therapeutics Inc. ANIK carrying 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 $1.21 to $1.31 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%.         

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