Biotech Values

[DewDiligence]

ESPR—(-20%)—reports modest HR=0.87/0.85 for MACE-4*/MACE-3*, respectively, in 14K-patient outcomes study of Nexletol:

https://finance.yahoo.com/news/landmark-clear-outcomes-study-demonstrates-153000166.html

Esperion today [Saturday 3/4/23] announced the full results from the landmark Cholesterol Lowering via Bempedoic acid, an ACL-Inhibiting Regimen (CLEAR) Outcomes trial, which were presented at the American College of Cardiology’s Annual Scientific Session & Expo together with the World Congress of Cardiology and simultaneously published in the New England Journal of Medicine. CLEAR Outcomes was a global study of nearly 14,000 patients with or at risk for cardiovascular disease who were unable to maximize or tolerate a statin.

The study showed that Nexletol significantly reduced the risk of hard MACE-4 and MACE-3 by 13% and 15%, respectively, and significantly reduced the risk of heart attack and coronary revascularization by 23% and 19%, respectively, as compared to placebo.

… Bempedoic acid (contained in Nexletol and Nexlizet (bempedoic acid and ezetimibe [Zetia]) tablets) now becomes the first LDL-C lowering therapy since statins proven to lower hard ischemic events, not only in those with ASCVD but also in the large number of primary prevention patients for whom limited therapies exist. The Company believes that it remains on track to submit regulatory filings to the FDA and EMA in 1H 2023.

Although the trial hit its primary endpoints, the effect size relative to placebo for MACE-3* and MACE-4* is underwhelming and evidently less than what most investors were expecting.

Nexletol and Nexlizet received FDA approval in Feb 2020 (#msg-153971756, #msg-154038141), but sales have been weak (#msg-166400676). The modest showing on the outcomes study described above is unlikely to boost sales (IMO) and may even reduce them.

*MACE-3 is a composite of cardiovascular death, nonfatal MI, and nonfatal stroke; MACE-4 (as defined in this outcomes trial) is a composite of the three components of MACE-3 plus cardiovascular-related hospitalization.