A first healthy volunteer has enrolled in a randomized, double-blind Phase 1 study to compare the gastrointestinal (GI) tolerability and safety of oral Tecfidera to Bafiertam, an oral bioequivalent in treating relapsing forms of multiple sclerosis (MS), Banner Life Sciences announced.
Tecfidera (dimethyl fumarate, marketed by Biogen) is an approved capsule therapy for relapsing MS patients that modulates the immune system in order to prevent autoimmune attacks. Tecfidera is a pro-drug that is metabolized by the liver from dimethyl fumarate to monomethyl fumarate.
Bafiertam, in development by Banner Life Sciences, is a monomethyl fumarate compound that has been given tentative approval as a Tecfidera bioequivalent by the U.S. Food and Drug Administration (FDA). Bioequivalence means that equivalent doses of two medicines provide the same amount of the active ingredient, at the same rate, and at the specific site of action.
Its approval is tentative pending the outcome of litigation initiated by Biogen, or the close of that company’s Tecfidera patent, set to expire in June 2020.
Patients treated with Tecfidera can experience a range of gastrointestinal symptoms, such as abdominal pain, nausea, diarrhea, vomiting, and indigestion.
“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,” Franck Rousseau, MD, Banner’s CEO, said in press release.
The Phase 1 trial (NCT04022473) will compared the GI tolerability of Bafiertam to Tecfidera in up to 200 healthy adults. Participants will be randomly assigned to one of the two therapies and followed for five weeks, as adverse GI symptoms typically appear in the first weeks of treatment.
In the first phase (titration period), volunteers will receive either 95 mg of Bafiertam or 120 mg of Tecfidera twice daily for seven days. The second phase (maintenance period) lasts for four weeks, and participants will be given either 190 mg of Bafiertam or 240 mg of Tecfidera twice a day.
Daily gastrointestinal symptoms such as nausea, diarrhea, upper abdominal pain, lower abdominal pain, vomiting, constipation, bloating, and flatulence will be recorded and analyzed. Symptom severity will be assessed on a scale from zero (no adverse symptoms) to 10 (severe adverse symptoms) throughout the study.
Company officials expect Bafiertam to cause fewer and less severe GI symptoms compared to Tecfidera.
“Since Bafiertam meets the FDA’s required bioequivalence, safety, and efficacy at lower doses than Tecfidera, and is MMF [monomethyl fumarate] rather than dimethyl fumarate, we think it has the potential to be better tolerated,” Rousseau said.
This study, still recruiting volunteers at its single site in Missouri, is expected to end in late October.
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