HIGH POINT, N.C.--(BUSINESS WIRE)--Banner Life Sciences LLC (Banner), a privately held specialty pharmaceutical company, announced today that the first subject has been enrolled in a randomized, double-blind study to compare gastrointestinal (GI) tolerability of orally-administered BAFIERTAM™ or Tecfidera® at therapeutic doses, over five weeks.
In January 2019, Banner announced that the U.S. Food and Drug Administration (FDA) had granted tentative approval of BAFIERTAM, a monomethyl fumarate (MMF) 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 U.S. Patent Number 7,619,001. Biogen’s Tecfidera contains dimethyl fumarate rather than MMF.
“While fumarates represent a significant therapeutic tool for the treatment of relapsing-remitting multiple sclerosis, gastrointestinal tolerance is a common issue and often leads to early discontinuation of treatment,” said Franck Rousseau, M.D., Chief Executive Officer of Banner. “This seems to be especially the case in the first few weeks after therapy is initiated. Since BAFIERTAM meets the FDA’s required bioequivalence, safety, and efficacy at lower doses than Tecfidera, and is MMF rather than dimethyl fumarate, we think it has the potential to be better tolerated.”
About the Study
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. Additional information regarding the study is available at www.ClinicalTrials.gov (# NCT04022473).
About Relapsing-Remitting Multiple Sclerosis
Relapsing-remitting multiple sclerosis (RRMS), 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 percent of patients diagnosed with MS, or an estimated 2 million people worldwide.1 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 (Nrf2) 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. 2
About Banner Life Sciences LLC
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.
1 National Multiple Sclerosis Society