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LONDON, UK / ACCESSWIRE / July 27, 2017 / Pro-Trader Daily takes a look at the latest corporate events and news making the headlines for Flex Pharma, Inc. (NASDAQ: FLKS), following which we have published a free report that can be viewed by signing up at http://protraderdaily.com/optin/?symbol=FLKS. The clinical-stage biotechnology Company announced on July 25, 2017, that the US Food and Drug Administration (FDA) has granted Fast Track designation for the development of FLX-787, i.e. the Company's co-activator of TRPA1 and TRPV1 to treat severe muscle cramps in patients with amyotrophic lateral sclerosis (ALS). For immediate access to our complimentary reports, including today's coverage, register for free now at:
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As of now, no drugs have been approved in the US for this condition. Flex Pharma has been developing innovative and proprietary treatments for cramps and spasticity associated with serious neurological diseases such as amyotrophic lateral sclerosis (ALS), multiple sclerosis (MS), and Charcot-Marie-Tooth (CMT). The above mentioned fast track designation is expected to speed up the clinical development and review of drugs required to address the unmet medical need and treat serious conditions related to ALS.
FDA Approval Driven by Current Lack of Effective Treatments for ALS
William McVicar, Ph.D., Flex Pharma interim President, and CEO stated that the receipt of Fast Track designation from the FDA underlines the grave nature of cramps for patients suffering from ALS and the existing lack of safe and effective treatments for them. The Fast Track designation also signifies an opportunity for greater collaboration with FDA. This will also act as an important catalyst for their development program for FLX-787.
It is anticipated that the Phase-2 clinical trials in ALS and CMT will initiate this quarter, which will make FLX-787 one of the most advanced, novel compounds in the clinic for degenerative neurological diseases.
He mentioned that his R&D team is focused on the execution of these new Phase-2 IND studies as well as completion of the ongoing exploratory Phase-2 spasticity study in MS in Australia. These studies are expected to yield several important data readouts in 2018.
About the FLX-787 Clinical Trial Program
The COMMEND trial is a Phase-2 clinical trial that has been designed to assess FLX-787 in patients with motor neuron disease (MND), primarily focused on ALS, who suffer from cramps. On the other hand, the COMMIT trial is a Phase-2 clinical trial that is designed to evaluate FLX-787 in patients with CMT. These randomized, controlled, double-blinded, parallel design trials in the US will include a run-in period to establish a baseline in cramp frequency. After which, patients will be randomized to 30 mg of FLX-787 administered three times a day, or control, for 28 days; on this basis, patients will be evaluated for changes in cramp frequency as the primary endpoint, with a number of other secondary endpoints.
Flex Pharma to Prioritize US Phase-2 COMMEND Trial over its Australian Study
Flex Pharma Chief Medical Officer Thomas Wessel, M.D., Ph.D. stated that the COMMEND trial, primarily focused on ALS patients in the US, has certain advantages to the Company's ongoing ALS study in Australia, including longer run-in and treatment periods, increased dosing, a parallel design, and of course a much larger population from which patients can be recruited. Therefore, the Company has decided to prioritize and focus its efforts on the COMMEND study and end the exploratory Australian ALS study early, with around a dozen patients. He believes that the data from the Australian study will apprise the Company's larger COMMEND clinical trial, mainly about baseline cramp frequency and intra-subject variability, which could impact the calculation of sample size and other aspects of trial conduct for the US study.
How will the Fast Track Designation Help?
The Fast Track designation will enable Flex Pharma to have a more frequent dialogue with the Neurology Division at FDA about its drug development plan, data requirements, and clinical trial design, throughout the drug development and review process. This will allow the Company to offer important new drugs to its customers more rapidly. Through this Fast Track program, a product might be eligible for priority review at the time of a New Drug Application (NDA) filing and might also be eligible for submitting completed sections of the NDA on a rolling basis, before the complete application is submitted.
Last Close Stock Review
At the closing bell, on Wednesday, July 26, 2017, Flex Pharma's stock tumbled 5.77%, ending the trading session at $4.08. A total volume of 325.52 thousand shares have exchanged hands, which was higher than the 3-month average volume of 138.92 thousand shares. The Company's stock price surged 14.61% in the last three months. The stock currently has a market cap of $76.17 million.
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