FDAnews Drug Daily Bulletin

Sanofi and Regeneron to Partner with Cardiologists on Clinical Trial Enrollment

Dec. 20, 2013

Sanofi and Regeneron are teaming up with the American College of Cardiology’s (ACC) Pinnacle registry in an effort to enhance patient identification and recruitment for their Phase III Odyssey outcomes trial of a human monoclonal antibody and next-generation heart drug.

The heart drug, alirocumab, is a PCSK9 inhibitor, a new class of therapies also under development by Amgen, Roche, Bristol-Myers Squibb, Merck and Alnylam Pharmaceuticals.

The Odyssey trial involves patients 40 years and older who have been hospitalized for acute coronary syndrome within at least 16 weeks and who have evidence of dietary and medical management of dyslipidemia.

Sanofi and Regeneron will be making use of the ACC’s Pinnacle registry, which gathers daily data on 25,000 to 45,000 cardiology patients at around 900 locations across the country.
Regeneron’s Sandra Sexton says this is the first time the registry has been used in this way.

Cardiologists treating these patients are made aware of the trial and the closest sites and can decide, together with patients, whether to participate. If they decide to enroll, they submit their information to the trial site, ACC spokesperson Brendan Mullen told Drug Daily Bulletin Thursday. Mullen stressed that the ACC does not share patient-level data with the drugmakers.

The Odyssey trial is scheduled to be completed in March 2018. — Lena Freund

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