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-- Phase 2 Trials in ALS and CMT to Commence in the US This Division --
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-- Prioritizing US Phase 2 COMMEND Trial; Basic Australian ALS Abstraction to End Aboriginal --
BOSTON--(BUSINESS WIRE)-- Click to Tweet this News
Flex Pharma, Inc. (NASDAQ:FLKS), a clinical-stage biotechnology aggregation that is developing avant-garde and proprietary treatments for cramps and spasticity associated with austere acoustic diseases including amyotrophic crabbed sclerosis (ALS), assorted sclerosis (MS), and Charcot-Marie-Tooth (CMT), today appear that the US Food and Biologic Administration (FDA) has accepted Fast Track appellation for the development of FLX-787, the Company's co-activator of TRPA1 and TRPV1, to amusement astringent beef cramps in patients with ALS. There are currently no drugs accustomed in the US for this condition.Fast Track appellation is advised to advance the analytic development and analysis of drugs to amusement austere altitude that abode an unmet medical need.
"We accept the cancellation of Fast Track appellation from the FDA highlights the austere attributes of cramps for patients adversity from ALS and the accepted abridgement of safe and able treatments. The Fast Track appellation represents an befalling for alike afterpiece accord with FDA and an important agitator for our development affairs for FLX-787," declared William McVicar, Ph.D., Flex Pharma acting President and CEO. "With Phase 2 analytic trials in both ALS and CMT accepted to admit this division in the US, FLX-787 will be amidst the best advanced, atypical compounds in the dispensary for these degenerative acoustic diseases. The R&D aggregation is focused on the beheading of these new Phase 2 IND studies, as able-bodied as achievement of the advancing basic Phase 2 spasticity abstraction in MS in Australia. These studies are accepted to crop several important abstracts readouts in 2018."
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"Our COMMEND trial, which is a Phase 2 abstraction of primarily ALS patients in the US, has assertive advantages to our advancing ALS abstraction in Australia, including best altercation and analysis periods, added dosing, a alongside design, and of advance a abundant beyond citizenry from which patients can be recruited. As a result, we accept adopted to accent and focus our efforts on the COMMEND abstraction and will end the basic Australian ALS abstraction early, with almost a dozen patients," acclaimed Flex Pharma Chief Medical Officer Thomas Wessel, M.D., Ph.D. "The abstracts from the Australian abstraction will acquaint our beyond COMMEND analytic trial, decidedly apropos baseline ache abundance and intra-subject variability, which could access sample size adding and added aspects of balloon conduct for this important US study."
Fast Track appellation allows for a added common chat with the Neurology Division at FDA on the company's biologic development plan, abstracts requirements and analytic balloon design, throughout the biologic development and analysis process, with the ambition of accepting important new drugs to patients added rapidly. Through the Fast Track program, a artefact may be acceptable for antecedence analysis at the time of a New Biologic Appliance (NDA) filing and may additionally be acceptable to abide completed sections of the NDA on a rolling basis, afore the complete appliance is submitted.
About the FLX-787 Analytic Balloon Program
The COMMEND balloon is a Phase 2 analytic balloon advised to appraise FLX-787 in patients with motor neuron ache (MND), focused on ALS, who ache from cramps. The COMMIT balloon is a Phase 2 analytic balloon advised to appraise FLX-787 in patients with CMT. These randomized, controlled, double-blinded, alongside architecture trials in the US will accommodate a altercation aeon to authorize a baseline in ache frequency. Patients will again be randomized to 30 mg of FLX-787 administered three times a day, or control, for 28 days. Patients will be evaluated for changes in ache abundance as the primary endpoint, with a cardinal of accessory endpoints.
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About Flex Pharma
Flex Pharma, Inc. is a clinical-stage biotechnology aggregation that is developing avant-garde and proprietary treatments for cramps and spasticity associated with the astringent acoustic diseases of ALS, MS and borderline neuropathies such as Charcot-Marie-Tooth (CMT). Flex Pharma was founded by National Academy of Science associates Rod MacKinnon, M.D. (2003 Nobel Laureate), and Bruce Bean, Ph.D., accustomed leaders in the fields of ion channels and neurobiology, forth with Chair Christoph Westphal, M.D., Ph.D.
Forward-Looking Statements
This columnist absolution contains advanced statements for purposes of the safe anchorage accoutrement of the Private Securities Litigation Reform Act of 1995. Advanced statements accommodate statements apropos our intentions, beliefs, projections, outlook, analyses or accepted expectations concerning, amid added things, the architecture and timing of advancing and advancing analytic trials, including the timing for after-effects of our analytic trials, and our expectations apropos the akin of alternation with the FDA and added allowances associated with FLX-787 accepting been accepted Fast Track status. These advanced statements are based on management's expectations and assumptions as of the date of this columnist absolution and are accountable to abundant risks and uncertainties, which could account absolute after-effects to alter materially from those bidding or adumbrated by such statements. These risks and uncertainties include, afterwards limitation: the status, timing, costs, after-effects and estimation of our analytic studies; the uncertainties inherent in administering analytic studies; our adeptness to accept patients in anniversary of analytic studies on a appropriate basis; expectations of our adeptness to accomplish authoritative filings and access and advance authoritative approvals; availability of allotment acceptable for our accountable and adventitious operating costs and basic amount requirements; the inherent uncertainties associated with bookish property; and added factors discussed in greater detail beneath the branch "Risk Factors" in our Annual Report on Form 10-K for the year concluded December 31, 2016 and consecutive filings with the Securities and Exchange Commission (SEC). You are encouraged to apprehend our filings with the SEC, accessible at www.sec.gov, for a altercation of these and added risks and uncertainties. Any advanced statements that we accomplish in this columnist absolution allege alone as of the date of this columnist release. We accept no obligation to amend our advanced statements whether as a aftereffect of new information, approaching contest or otherwise, afterwards the date of this columnist release.
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View antecedent adaptation on businesswire.com: http://www.businesswire.com/news/home/20170725005512/en/
Source: Flex Pharma, Inc.
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