Sanofi’s alirocumab monotherapy reduced LDL cholesterol three times more than ezetimibe

French drug major Sanofi (Euronext: SAN) and partner USA-based Regeneron Pharmaceuticals (Nasdaq: REGN) this morning released results from the Phase III ODYSSEY MONO trial with alirocumab, an investigational monoclonal antibody targeting PCSK9 (proprotein convertase subtilisin/kexin type 9), showing it met its primary efficacy endpoint.

The mean low-density lipoprotein-cholesterol (LDL-C, or “bad” cholesterol) reduction from baseline to week 24, the primary efficacy endpoint of the study, was significantly greater in patients randomized to alirocumab, as compared to patients randomized to ezetimibe (47.2% versus 15.6%, p<0.0001). In the trial, which employed a dose increase (up-titration) for patients who did not achieve an LDL-C level of 70 milligrams/deciliter (mg/dL), the majority of patients remained on the initial low dose of alirocumab of 75mg.

$3 billion sales forecast

"Physician feedback suggests high awareness amongst cardiologists and planned prescribing habits support multi-billion dollar potential for the class," Deutsche Bank analysts wrote in a note ahead of the latest study results, forecasting peak annual sales of alirocumab of more than $3 billion. Independent research firm BioMedTracker quoted by Reuters sees sales of alirocumab reaching $3.7 billion by 2023.

“We are excited with the findings from the first Phase III trial with alirocumab. While the majority of our clinical program is investigating alirocumab in combination with lipid-lowering therapies, these monotherapy results are encouraging,” said Jay Edelberg, head of the PCSK9 Development and Launch Unit, at Sanofi. “As in this trial, several of our Phase III studies will utilize an up-titration approach, the aim of which is to bring patients to goal with the lowest effective dose of anti-PCSK9 antibody. We look forward to results from the remaining Phase III trials, which are investigating alirocumab in a variety of patient populations, combinations with different background therapies, and dosing regimens,” he added.