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Another Nail In Amyloid Hypothesis Coffin? Merck Ends Pivotal BACE Inhibitor Study

 
• By Mandy Jackson

In another blow for the amyloid hypothesis in Alzheimer's disease, Merck ended its pivotal EPOCH study for the BACE inhibitor verubecestat based on an interim assessment that there was "virtually no chance of finding a positive clinical effect" in the nearly completed Phase II/III clinical trial.

Human brain illustrated with millions of small nerves - Conceptual 3d render

Merck & Co. Inc. revealed on Feb. 14 that it has ended the Phase II/III EPOCH clinical trial testing the BACE inhibitor verubecestat in mild-to-moderate Alzheimer's disease based on lack of efficacy, seeming to put another nail in the coffin for the amyloid hypothesis, although the company's Phase III trial in prodromal Alzheimer's is ongoing with results expected in Feb. 2019.

An external data monitoring committee determined after an interim safety analysis that verubecestat (MK-8931) had "virtually no chance of finding a positive clinical effect" on cognition and function in EPOCH, which is not entirely surprising given the long and growing list of disappointing results for drugs that target the amyloid protein in Alzheimer's disease (AD)

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Insilico Fast-Tracks First AI-Designed TNIK Inhibitor Into Phase III 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.

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.

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Sanofi R&D Head’s Words Of Wisdom For Biotechs

 
• By Kevin Grogan

Houman Ashrafian tells delegates at Swiss Biotech Day that ‘literally only two things matter in our industry – target credentialing and differentiated pharmacology. The rest is execution.’

Marea Eyes Cardioprotective Benefit With ANGPTL4 Inhibition

 
• By Joseph Haas

Phase IIa data for ANGPTL4-targeted antibody shows reduced triglycerides and remnant cholesterol, which Marea asserts indicates potential to protect against cardiovascular outcomes.

First Win For AstraZeneca’s Enhertu In Early-Stage Breast Cancer Treatment

 
• By Andrew McConaghie

Already dominating in later lines of breast cancer treatment, Enhertu could now displace both chemotherapy combinations and Roche’s Kadcyla in early-stage HER2-positive patients.