2:24 PM
Jun 13, 2018
 |  BC Extra  |  Clinical News

Flex downsizing on troubles with sole clinical program

Flex Pharma Inc. (NASDAQ:FLKS) plummeted $3.14 (75%) to $1.04 on Wednesday when the company said it is cutting headcount by about 60% after discovering its sole clinical program, FLX-787, will require additional work that stretch beyond the biotech's current means. Flex said it will evaluate strategic alternatives, including a sale.

Flex found that a subset of patients in two Phase II trials could not tolerate oral FLX-787 at 30 mg. It said the signal indicates that additional formulation and dose-ranging studies are required, "which is challenging for the company based upon our current resources.” Flex is ending both trials, which were evaluating FLX-787 to treat amyotrophic lateral sclerosis (ALS) and Charcot-Marie-Tooth (CMT) disease, respectively, and suspending a third program of FLX-787 to treat multiple sclerosis.

In March, the company reported top-line data from a Phase II trial showing that the candidate significantly reduced the frequency of cramps and spasms in MS patients compared with placebo. FLX-787 has Fast Track designation from FDA to treat ALS.

Elizabeth Woo, Flex SVP of investor relations and corporate communications, declined to elaborate on the tolerability issues.

Flex expects to complete the majority of the headcount reduction this month. As part of the restructuring, Thomas Wessel will step down as CMO and become an external advisor, effective June 26.

FLX-787 is a dual transient receptor potential vanilloid 1 (TRPV1; VR1) and transient receptor potential A1 (TRPA1) agonist.

At March 31, Flex had $41.9 million in cash and recorded a three-month operating loss of $8.3 million. In 2017, the company reported an operating loss of $34.7 million.

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