Regeneron Pharmaceuticals Inc. (REGN) and partner Sanofi (SNY) reported encouraging top-line data from a phase III study (ODYSSEY MONO: n=103) on their candidate alirocumab. The randomized, double-blind, active-controlled, parallel-group study is evaluating the efficacy and safety of alirocumab as a monotherapy over 24 weeks in patients suffering from primary hypercholesterolemia (presence of high cholesterol levels in the blood). The patients stand a moderate risk of being affected by cardiovascular diseases.
Alirocumab is a proprotein convertase subtilisin/kexin type 9 (PCSK9) antibody. Alirocumab works by blocking the PCSK9 pathway to lower LDL-cholesterol levels.
Data from the study revealed that 24 weeks of treatment with alirocumab lowered levels of low-density lipoprotein-cholesterol (LDL-C/ bad cholesterol) by 47.2% compared to a 15.6% reduction witnessed in patients treated solely with Merck & Co. Inc.’s (MRK) cardiovascular drug Zetia (ezetimibe: 10 mg). Patients in the alirocumab arm injected themselves with 75 mg of the candidate every 14 days. The dosage was doubled at the 12th week of the study in patients with LDL cholesterol levels exceeding 70 mg/dl at week 8. However, the high dose was not needed in majority of the patients. Regeneron/Sanofi intend to present detailed data from the study at a medical conference next year.
We note that ODYSSEY MONO is part of the ODYSSEY phase III program (n>23,000). The program includes multiple trials. Enrollment has been completed in most of the trials. Successful development of the cholesterol fighter would boost the companies’ top line significantly as the cardiovascular market offers significant commercial potential. Moreover, the available statin therapies fail to bring the LDL cholesterol at acceptable levels in many patients. We note that AMG 145 is another cholesterol management phase III candidate. AMG 145 is also a PCS K9 antibody.
Regeneron, a biopharmaceutical company, currently carries a Zacks Rank #3 (Hold). Alexion Pharmaceuticals, Inc. (ALXN) looks attractive in the biopharma space with a Zacks Rank #1 (Strong Buy).
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