AHA 2021 – Merck’s oral cholesterol lowerer could heap more misery on Esperion

Merck & Co might have succeeded where others have failed and developed an oral PCSK9 inhibitor. Data presented at the American Heart Association meeting today, although early, put the cholesterol-lowering abilities of Merck’s project, MK-0616, on a par with injectable PCSK9 MAbs from Amgen and Sanofi/Regeneron and Novartis’s longer-lasting RNAi therapy Leqvio. The results could also represent another nail in the coffin for Esperion; that group has struggled to sell its oral therapy Nexletol, which it had positioned between statins and PCSK9s, arguing a convenience advantage over the latter. However, cholesterol lowering of 15-25% with Nexletol alone, or around 38% when combined with ezetimibe, pales against around 65% LDL-C lowering with Merck’s agent in phase 1. Merck’s Douglas Johns, presenting the MK-0616 results, admitted that larger studies would now be needed. But he added that availability of an oral agent could extend the reach of PCSK9 inhibitors, whose uptake has been limited. Still, one reason for lack of use has been the high cost of the MAbs – Mr Johns told a press briefing that it was too early to talk about MK-0616's price tag, but that this was something Merck was taking “very seriously”.