XenoPort has submitted an Investigational New Drug (IND) application to the FDA to commence XP23829 clinical studies as a potential treatment for relapsing-remitting multiple sclerosis (RRMS).
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The study is designed to evaluate the safety, tolerability and pharmacokinetics of XP23829, including confirmation of its conversion to monomethyl fumarate (MMF).
The performance of four novel formulations of XP23829 designed to have different drug release mechanisms and/or time profiles will also be examined, the company said.
XenoPort chief executive officer Ronald Barrett said, "We are hopeful that our first Phase 1 clinical trial will provide evidence of safety and tolerability and also provide pharmacokinetic data that might support once-a-day dosing of XP23829."