June 22, 2024

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Merck Bets on Oral PCSK9 Inhibitor

Merck Bets on Oral PCSK9 Inhibitor

Merck Bets on Oral PCSK9 Inhibitor.

On August 25th, Merck  announced the initiation of the Phase III clinical trial program for MK-0616, called CORALreef.

MK-0616 is an oral proprotein convertase subtilisin/kexin 9 (PCSK9) inhibitor being evaluated for the treatment of adult hypercholesterolemia.

This marks the world’s first Phase III clinical trial program for an oral PCSK9 inhibitor.

While injectable PCSK9 inhibitors like Amgen’s Repatha (evolocumab), Sanofi/Regeneron’s Praluent (alirocumab), and Novartis’ small interfering RNA (siRNA) drug Leqvio (inclisiran) have been approved and marketed, they have not met market expectations.

Recently, Shinda Biotech’s Xinbile (toralesemonab), a domestically produced PCSK9 lipid-lowering drug, gained approval in China.

Merck Sharp & Dohme hopes to position MK-0616 as the world’s first oral PCSK9 inhibitor.

Merck Sharp & Dohme is conducting three Phase III clinical trials for MK-0616.

The first two are similar studies evaluating the impact of MK-0616 on LDL-C levels after 24 weeks. Merck Sharp & Dohme aims to complete these two studies by September 2025.

The third clinical trial focuses on cardiovascular outcomes. In this trial, Merck Sharp & Dohme will follow 14,500 patients for six years to test whether MK-0616 can reduce major cardiovascular adverse events in high-risk populations. The primary completion date for this trial is the end of 2029, reflecting a longer duration compared to earlier assessments of the impact of PCSK9 inhibition on cardiovascular outcomes.

When Amgen, Regeneron, and Sanofi initially developed injectable PCSK9 drugs, they assessed the impact on cardiovascular outcomes with an average follow-up period of 2.2 to 2.8 years. Subsequent long-term follow-up trials found that the impact on cardiovascular outcomes increased over time, suggesting that developers might have shown more profound effects if their primary studies had extended longer.

Merck Sharp & Dohme aims to learn from the lessons of earlier projects in this field to avoid missing out on the maximum impact for future approval labels due to “if the trial duration is too short.”

Merck Bets on Oral PCSK9 Inhibitor

MK-0616 is a macrocyclic peptide that binds to PCSK9, inhibiting its interaction with LDL receptors. The structural formula of MK-0616 was first disclosed by drughunter.com in March of this year.

Merck Bets on Oral PCSK9 Inhibitor

(source:internet, reference only)

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