24 July 2019 - - US-based specialty pharmaceutical company Banner Life Sciences LLC (Banner) has enrolled the first subject in a randomised, double-blind study to compare gastrointestinal tolerability of orally-administered Bafiertam or Tecfidera at therapeutic doses, over five weeks, the company said.
In January 2019, Banner announced that the US Food and Drug Administration had granted tentative approval of Bafiertam, a monomethyl fumarate indicated for the treatment of patients with relapsing forms of multiple sclerosis, with full approval expected in 2020.
Approval may be accelerated based on the outcome of pending litigation with Biogen, Inc. regarding US Patent Number 7,619,001. Biogen's Tecfidera contains dimethyl fumarate rather than MMF.
Study BLS-11-109 is a randomized, double-blind study to compare gastrointestinal tolerability in healthy volunteers following five weeks of oral administration of Bafiertam or Tecfidera at their therapeutic doses.
Subjects will record daily GI symptoms. The primary endpoints include the rate and severity of gastrointestinal adverse events.
Relapsing-remitting multiple sclerosis, the most common form of MS, is a debilitating autoimmune disease characterized by inflammatory attacks to the central nervous system followed by periods of remission.
RRMS affects approximately 85% of patients diagnosed with MS, or an estimated 2 m people worldwide.
There is no cure for MS and disease progression and degree of impairment vary widely by patient depending on the location and extent of nerve damage.
Treatment regimens for RRMS focus on symptom management, slowing disease progression and reducing relapses.
Bafiertam (monomethyl fumarate) is indicated for the treatment of patients with relapsing forms of multiple sclerosis. While Bafiertam has been shown to activate the nuclear factor (erythroid-derived 2)-like 2 pathway, the precise mechanism of action has not been fully elucidated.
The prodrug of Bafiertam was shown in two separate studies to reduce the risk of relapse by 49% and 34%, and to reduce the number of relapses by 53% and 44%, compared to placebo. 
Banner Life Sciences LLC, a privately held clinical-stage pharmaceutical company, combines a proven history of formulation expertise with proprietary technologies to create specialty pharmaceuticals that solve real unmet clinical needs.