-- FLX-787 Granted Fast Track Designation for ALS --
-- US Phase 2 ALS Trial Initiated under IND --
-- US Phase 2 CMT Trial Commencing Third Quarter --
Conference Call Scheduled Today at 8:45 a.m. ET
BOSTON--(BUSINESS WIRE)--Click to Tweet
Flex Pharma, Inc. (NASDAQ: FLKS), a clinical-stage biotechnology company that is developing innovative and proprietary treatments for cramps and spasticity associated with severe neurological diseases such as multiple sclerosis (MS), Charcot-Marie-Tooth (CMT) and amyotrophic lateral sclerosis (ALS) under FDA Fast Track designation, today reported financial results for the quarter ended June 30, 2017 and provided an update on its clinical development and corporate activities.
“We have accomplished a number of important development objectives over these past few months. First and foremost, the recent Fast Track designation represents a validation by FDA that cramps are a severe, unmet medical need in ALS. We see greater collaboration with FDA under Fast Track as an important catalyst in our efforts to accelerate the development of FLX-787 to address the suffering of patients with painful, debilitating cramps as a consequence of their severe neurological disease,” stated Dr. William McVicar, President and CEO of Flex Pharma. “In addition, our IND became effective, allowing us to expand our clinical program to the US, and we have now initiated our Phase 2 ALS trial, with our Phase 2 CMT trial soon to follow. The 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.”
Recent Business Highlights
- Clinical Efforts
- In early August, the Company initiated its Phase 2 randomized, controlled, double-blinded, parallel design trial in the US, referred to as the COMMEND trial, to evaluate FLX-787, the Company’s co-activator of TRPA1 and TRPV1, in patients with motor neuron disease (MND), focused on ALS, who suffer from cramps. The Company expects to report topline results from this study in the middle of 2018.
- In July, the Company announced that the Food and Drug Administration (FDA) granted Fast Track Designation for the development of FLX-787 to treat severe muscle cramps in patients with ALS. There are currently no drugs approved in the US for this condition. Fast Track Designation is intended to accelerate the clinical development and review of drugs to treat serious conditions that address an unmet medical need. In addition, the Company announced that it has prioritized the larger US Phase 2 ALS trial over the small, exploratory Australian ALS study due to several advantages of the US Phase 2 ALS trial. As a result, the exploratory Australian ALS study will end early, with roughly a dozen patients.
- In June, the Inherited Neuropathies Consortium (INC) voted to endorse the Company’s US Phase 2 Trial of FLX-787 in CMT patients who suffer from cramps. The INC is an integrated group of academic medical centers, patient support organizations, and clinical research resources dedicated to conducting clinical research in CMT and to improving the care of patients (www.rarediseasesnetwork.org/cms/inc). There are currently no drug products approved in the US for this condition. The Company expects to begin enrolling US patients during the third quarter in this randomized, controlled, double-blinded, parallel design study, referred to as the COMMIT trial.
- In April, the Company’s investigational new drug (IND) application for FLX-787 for patients with ALS became effective, allowing the Company to commence its US Phase 2 clinical trial of FLX-787 in ALS patients who suffer from cramps as a consequence of the disease.
- In its abstract titled, “Chemical Neuro Stimulation by FLX-787, a co-activator of TRPA1/TRPV1, for the Potential Treatment of Cramps, Spasms and Spasticity,” the Company presented human efficacy data from its study in nocturnal leg cramps (NLC) at the American Academy of Neurology (AAN) 69th Annual Meeting in Boston, MA in April. When a neurologist evaluated, in a blinded manner, subjects likely to have NLC based upon a questionnaire administered after the study was completed, the data from first treatment exposure of these 26 subjects showed a statistically significant effect in the reduction in cramp frequency when compared to placebo (p=0.03).
- Consumer Business
- For the quarter ended June 30, 2017, the Company recorded approximately $336,000 in total revenue for its consumer product, HOTSHOT®, launched in June 2016. The Company expects full year revenues for 2017 to exceed 2016.
- IRONMAN® and HOTSHOT, the only scientifically proven solution for preventing and treating muscle cramps, have partnered to designate HOTSHOT as the Official Muscle Cramp Product of the IRONMAN US Series. To aid athletes, HOTSHOT will be on-course at all the remaining 2017 IRONMAN events in the US, as well as at the 2017 IRONMAN and IRONMAN 70.3 World Championship events.
- Strengthened Leadership Team
- In July, Flex Pharma’s Board of Directors appointed William McVicar, Ph.D., as President and CEO. Dr. McVicar brings approximately 30 years of clinical development experience to the Company, formerly serving as the Company’s President of Research and Development. In June, Christoph Westphal, M.D., Ph.D., transitioned from his role as CEO and continues to serve as Flex Pharma’s Chairman of the Board. Prior to joining Flex Pharma, Dr. McVicar served as Executive Vice President of Pharmaceutical Development, Chief Scientific Officer, and President during his tenure at Inotek. As Vice President of Development Operations at Sepracor, he oversaw the development, FDA review, and approval of multiple NDAs and SNDAs, including BROVANA®, XOPENEX MDI®, and XOPENEX’s pediatric approval, which were each approved in a single 10-month review cycle. Prior to Sepracor, Dr. McVicar held various positions of increasing responsibility at Sandoz, Novartis and Rhone Poulenc Rorer.
Second Quarter 2017 Financial Results
