Regulatory Index News: 13/06/2018

Welcome to your Regulatory Index News digest for today. Take a look here for reports of discontinued trials, positive trial results and a fall in shares for gene-editing biotech firms.

AstraZeneca and Lilly discontinue two Phase 3 Alzheimer's disease trials

An independent data monitoring committee has found that AstraZeneca and Lilly's two Phase 3 trials, AMARANTH and DAYBREAK-ALZ, of the experimental (BACE) inhibitor lanabecestat were unlikely to meet their primary endpoints. Both trials had the same endpoint to assess any changes the drugs would have on the 13-item Alzheimer’s Disease Assessment Scale-Cognitive Subscale (ADAS-Cog13) for patients receiving study drug at 20mg or 50mg, or placebo, over a 104-week (AMARANTH) or 156 week (DAYBREAK-ALZ) period. This coincides with other high profile setbacks for MSD's and Janssen's BACE inhibitors verubecestat and atabecestat earlier this year. Please click here to read more on this from a PharmaTimes article.


Allergan’s migraine experimental drug atogepant hits primary trial targets

Allergan's data from its Phase 2b/3 trial (CGP-MD-01) shows it hit its primary target of preventing episodic migraine, with a significant reduction in monthly migraine/probable migraine (MPM) headache days in patients versus placebo. The oral atogepant drug also showed that it was well tolerated with no signs of hepatoxicity following daily administration over 12 weeks. The Allergan CEO, Bill Meury, said "we are excited about the prospects for this product and rapidly moving to the next stage of development for this product." These results follow Allergan's two positive Phase 3 pivotal trial results in early 2018 for its other oral investigational CGRP receptor antagonist ubrogepant also being developed for migraine prevention. Please click here to read more on this from a PharmaTimes article.



Shares in biotechs working on gene-editing therapies drop as technology used may increase cancer risk

Two studies published in the journal Nature Medicine on Monday raised concerns that an integral technology used in gene-editing therapies may actually increase the risk of cancer. It is believed that the use of the CRISPR-Cas09 system to help cut out and sometimes replace stretches of problematic DNA is most effective where the p53 gene is dysfunctional, i.e. in cells predisposed to becoming cancerous. These conclusions resulted in the shares of the Swiss biotech CRISPR Therapeutics being lowered by almost 13% by the close of the market along with others seeing smaller mid to high single-digit drops. Please click here to read more of this BioPharmaDive article.



Lorna Osborn

Date Published

13th June 2018

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