The Medicines Company MDCO announced that Independent Data Monitoring Committee (IDMC) has recommended that the ongoing phase III studies (ORION) of its candidate, inclisiran, will continue as designed and conducted, without modification. The IDMC’s recommendation was based on its planned review of unblinded safety and efficacy data from the trials.
Inclisiran is being evaluated to treat patients with atherosclerotic cardiovascular disease (ASCVD) and elevated LDL-cholesterol. The Medicines Company and Alnylam Pharmaceuticals, Inc. ALNY are collaborating over the advancement of inclisiran. Per the agreement, Alnylam completed certain pre-clinical studies and the phase I study, with The Medicines Company leading and funding the development of inclisiran from phase II forward. The Medicines Company will also look into the commercialization of the candidate.
The ORION phase III studies with 18-month follow up were fully enrolled with 3,660 patients randomized 1:1 across three trials — ORION-9 where 482 patients were randomized, ORION-10 in which 1,561 patients were randomized and 1,617 patients were randomized in the ORION-11 study— to receive either inclisiran or placebo. At the time of the IDMC review (its third since the ORION phase III program began), all randomized patients had been treated with two doses of inclisiran or placebo.
Until now, more than 1,550 patient-years of safety data has been accumulated in the ORION Phase III program, which represents a three-fold (or 1,000 patient-year) increase over the total patient exposure from the ORION phase I and phase II studies.
Medicines Company remains encouraged by the IDMC’s recommendation and continues to advance the inclisiran phase III program, with data readout expected in the second half of 2019.
Shares of Medicines Company have increased 28% year to date, against the industry’s decline of 9.5%.
Zacks Rank & Stock to Consider
The Medicines Company carries a Zacks Rank #3 (Hold).
Some better-ranked stocks from the same space are Aeglea BioTherapeutics, Inc. AGLE and ANI Pharmaceuticals, Inc. ANIP. Both Aeglea and ANI Pharmaceuticals carry a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Aeglea’s loss per share estimates have narrowed from $1.93 to $1.67 for 2018 and from $3.86 to $3.57 for 2019 over the past 60 days. The company delivered a positive earnings surprise in three of the trailing four quarters with an average beat of 19.32%. The stock has rallied 96.1% so far this year.
ANI Pharmaceuticals’earnings per share estimates have moved up from $5.54 to $5.70 for 2018 and from $5.72 to $6.15 for 2019 over the past 60 days. The company delivered a positive earnings surprise in three of the trailing four quarters with an average beat of 8.69%. The stock has rallied 2.5% so far this year.
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