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Merck’s Anti-PCSK9 Pill Sets Up Convenience Battle Against Infrequently Dosed Injectables

 
• By Alaric DeArment

The drug maker announced the start of a Phase III program for its oral PCSK9 inhibitor MK-0616, including a 14,550-patient outcomes trial set to start later in the year.

Merck announced the initiation of its Phase III program for oral PCSK9 inhibitor MK-0616 • Source: Shutterstock

Merck & Co., Inc. is making a big push with the Phase III program for its oral PCSK9 inhibitor MK-0616, but it remains to be seen whether an oral option will wind up becoming preferred over the currently approved injected drugs given that patients must still take Merck’s pill daily, whereas the injectables offer in many cases far less frequent dosing. In other words, the competition will likely come down to different ideas of what is more convenient.

Merck said 25 August that it had launched the Phase III program for MK-0616 consisting of three trials expected to enroll about 17,000 patients: CORALreef Lipids, in patients with at least one atherosclerotic cardiovascular disease (ASCVD) event or at intermediate to high risk of their first event; CORALreef HeFH, in adults with heterozygous familial hypercholesterolemia (HeFH); and CORALreef Outcomes, in adults with high cardiovascular risk receiving treatment with stable lipid-lowering therapies that

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Azafaros Banks Over €130m To Advance Nizubaglustat Into Phase III

 
• By Kevin Grogan

The therapy has been developed for GM1 and GM2 gangliosidoses and Niemann-Pick disease type C.

Lilly Builds Obesity Momentum With New SURMOUNT Data Besting Novo Nordisk

 
• By Alaric DeArment

The presentation and publication of the Phase IIIb study showing greater efficacy for Zepbound over Wegovy come at a time when competition has been heating up between the two obesity medications.

Insilico Fast-Tracks First AI-Designed TNIK Inhibitor For IPF

 
• By Dexter Jie Yan

InSilico will leapfrog Phase IIb to progress its AI-generated candidate for idiopathic pulmonary fibrosis directly into a Phase III trial in China, as it prepares for an IPO in Hong Kong.

Pipeline Watch: Six Approvals And Thirteen Phase III Readouts

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.

More from R&D

Pipeline Watch: Six Approvals And Thirteen Phase III Readouts

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.

Viatris Will File ‘Fast-Acting’ Meloxicam For FDA Approval This Year

 
• By Joseph Haas

Seven years after acquiring it, Viatris will seek approval of a meloxicam formulation for acute pain backed by data from two Phase III studies in post-surgical pain settings.

CRISPR Therapeutics Unveils Promising Early In Vivo Cholesterol-Lowering Results

 
• By Andrew McConaghie

The Phase I results are the best to date among ANGPTL3-targeting candidates in the pipeline, but analysts will wait for further updates before predicting a likely winner.