Shares of Sage Therapeutics (Nasdaq: SAGE ) fell about 22% to $10.25 in pre-market trading after the company reported disappointing topline results from the Phase 2 KINETIC 2 dose-ranging study of its investigational oral drug SAGE-324 (BIIB124) as a potential treatment for essential tremor (ET).
The study, conducted in partnership with US biotechnology giant Biogen (Nasdaq: BIIB), did not demonstrate a statistically significant dose-response relationship in participants with ET for its primary endpoint, change from baseline to day 91 in the Essential Tremor Rating Scale (TETRAS) Performance Subscale (PS) item 4 (upper extremities) total score.
Additionally, no statistically significant differences were demonstrated for any dose of SAGE-324 compared to placebo in change from baseline to Day 91 in TETRAS PS Item 4 total score or TETRAS Activities of Daily Living (ADL) composite score. Based on these results, Sage and Biogen have terminated the ongoing open-label safety study of SAGE-324 in ET and do not plan to further clinically develop SAGE-324 in ET. The companies are evaluating next steps, if any, for other potential indications.
This article is available to registered users only. To continue reading, please sign up for free. Your free trial will give you access to one week of exclusive features, interviews, roundups and commentary from some of the sharpest minds in the pharma and biotechnology sector. If you’re already a registered user, please log in. If your trial has expired, you can sign up here.
Log in to your account
Try before you buy
free
7-day trial access
Try our free trial. We bring you all the news that matters in the world of pharma and biotech. Exclusive features, podcasts, interviews, data analysis and commentary from our global network of life sciences journalists. Receive The Pharma Letter’s daily breaking news bulletins, free forever.
Become a subscriber
£820
Or £77 per month
Subscribe now Get unlimited access to leading pharma and biotech news, commentary and analysis. Latest updates on clinical trials, conferences, M&A, licensing, funding, regulatory, patent and legal, executive appointments, commercial strategies and financial results. A daily roundup of major pharma and biotech events. An in-depth monthly briefing on executive appointments and M&A news. Choose from our cost-effective annual package or flexible monthly subscriptions. Pharma Letter is a highly useful and valuable life sciences service that brings together daily updates on performance, talent and products. It’s a vital piece of information to keep you informed.
Chairman of Sanofi-Aventis UK
Sign up to receive email updates
Get daily news from leaders in biotech and pharmaceuticals
