Flex Pharma, Inc. (NASDAQ: FLKS), a clinical-stage biotechnology company that is developing innovative and proprietary treatments in Phase 2 randomized, controlled trials 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 announced that it has completed enrollment in its Phase 2 exploratory spasticity study in multiple sclerosis (MS) with approximately 50 patients in Australia. The randomized, placebo-controlled, blinded, cross-over study is designed to evaluate the safety and efficacy of FLX-787, the Company’s single molecule, chemically synthesized, dual A1/V1 transient receptor potential (TRPA1/V1) ion channel activator, in patients who suffer from spasticity, cramps and spasms as a consequence of MS.
MS is an autoimmune disease in which inflammatory lesions cause demyelination, and eventually degeneration, of nerve cells over years. This loss of nerve function can result in a variety of neurological deficits such as loss of sensation, vision, and muscle control and coordination, including spasticity. Spasticity is caused by damage to motor neurons in the brain and spinal cord. These lesions unmask hyperactive muscle stretch reflexes that result in persistent electrical activity in the muscle. This aberrant electrical activity – like that seen in muscle cramping – can be measured by electromyography (EMG). This stretch-triggered electrical activity in the muscle produces muscle stiffness during motion, or spasticity. We believe that this reflex hyperexcitability, like the alpha motor neuron hyperexcitability that produces cramping, can benefit from greater inhibition in the spinal circuitry generated by chemical neurostimulation with TRP activators like FLX-787. According to the National Institute of Neurological Disorders and Stroke, between 250,000 and 350,000 people in the United States suffer from MS and approximately 84% of patients with MS experience spasticity. This spasticity can be moderate to severe in almost half of the population, and the need for treatment to alleviate it increases as the disease progresses.
“Neurologists have very limited therapeutic options for patients suffering from MS spasticity and the current options are often suboptimal due to their associated side effects,” stated Flex Pharma Chief Medical Officer Thomas Wessel, M.D., Ph.D. “Our approach offers a potential important advantage as the drug candidate may reduce cramps or spasticity without the sedating side effects of many current therapies.”
“Given the recent ALS data supporting the efficacy signal of FLX-787 across multiple endpoints related to cramping and the associated pain, we are more encouraged that FLX-787 may demonstrate a similar effect in this larger exploratory MS study when we have the results at the end of the first quarter of next year,” said Dr. William McVicar, Flex Pharma President and CEO. “With data readouts in MS, ALS, and CMT expected over the next year, we are excited to advance the development of FLX-787 in multiple neurological settings to help these patients who have very limited treatment options to address their chronic cramping and spasticity.”
About Flex Pharma
Flex Pharma, Inc. is a clinical-stage biotechnology company that is developing innovative and proprietary treatments in Phase 2 randomized, controlled trials for cramps and spasticity associated with the severe neurological diseases of ALS, MS and peripheral neuropathies such as Charcot-Marie-Tooth (CMT). The Company’s lead candidate, FLX-787, is being developed under Fast Track designation for the treatment of severe muscle cramps associated with ALS. Flex Pharma was founded by National Academy of Science members Rod MacKinnon, M.D. (2003 Nobel Laureate), and Bruce Bean, Ph.D., recognized leaders in the fields of ion channels and neurobiology, along with Christoph Westphal, M.D., Ph.D.
This press release contains forward-looking statements for purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include statements regarding our intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things, the design and timing of ongoing and anticipated clinical trials, including the timing for results of our clinical trials. These forward-looking statements are based on management's expectations and assumptions as of the date of this press release and are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include, without limitation: the status, timing, costs, results and interpretation of our clinical studies; the uncertainties inherent in conducting clinical studies; our ability to enroll patients in each of clinical studies on a timely basis; expectations of our ability to make regulatory filings and obtain and maintain regulatory approvals; availability of funding sufficient for our foreseeable and unforeseeable operating expenses and capital expenditure requirements; the inherent uncertainties associated with intellectual property; and other factors discussed in greater detail under the heading "Risk Factors" in our Annual Report on Form 10-K for the year ended December 31, 2016 and subsequent filings with the Securities and Exchange Commission (SEC). You are encouraged to read our filings with the SEC, available at www.sec.gov, for a discussion of these and other risks and uncertainties. Any forward-looking statements that we make in this press release speak only as of the date of this press release. We assume no obligation to update our forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release.