Regeneron Pharmaceuticals, Inc.REGN announced that positive preliminary results from an ongoing, single-arm, open label, phase II proof-of-concept study on evinacumab in patients suffering from homozygous familial hypercholestrolemia (HoFH) were presented at the European Atherosclerosis Society Congress. Evinacumab is an experimental monoclonal antibody to angiopoietin-like protein 3.
Interim data showed that evinacumab in combination with other lipid-lowering therapies resulted in a mean reduction in low density lipoprotein cholesterol (LDL-C) in the first 4 patients by an additional 55% at week 4 compared to baseline, which was also the primary endpoint of the study. Between these 4 patients, the percent reductions in LDL-C ranged from 25-90%. Overall, the patients enrolled in the study saw their mean LDL-C levels decrease from 331mg/dL at baseline to 175mg/dL at week 4.
On the safety front, evinacumab was found to be well tolerated with no adverse event being reported leading to discontinuation. Meanwhile, the study is targeting to enrol up to 8 patients with HoFH.
We are encouraged by the company's progress with the candidate. The cholesterol management market represents a huge commercial potential.
We note that Regeneron received a huge boost when Praluent became the first PCSK9 inhibitor to gain approval in the U.S. The drug is also approved in the EU. Regeneron has co-developed Praluent with Sanofi SNY . The current payer restrictions are limiting the product's uptake though the companies expect a gradual uptick in sales.
PCSK9 inhibitors work by inhibiting PCSK9, a protein that reduces the liver's ability to remove "bad" cholesterol from the blood. Amgen Inc.'s AMGN PCSK9 inhibitor, Repatha, is also approved both in the U.S and EU.
Regeneron is a Zack Rank #3 (Hold) stock. ANI Pharmaceuticals, Inc. ANIP is a better-ranked stock in the health care sector, sporting a Zacks Rank #1 (Strong Buy).
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