Xenoport, Inc. (XNPT) recently announced initial results from two phase I studies on XP23829, a fumaric acid ester candidate. XP23829 is a prodrug of monomethyl fumarate (MMF). XP23829 is being evaluated for the treatment of relapsing-remitting multiple sclerosis and/or psoriasis. Xenoport’s stock price was up significantly on the news.
The first, randomized, double-blind, placebo-controlled, multiple ascending dose-escalation study evaluated the pharmacokinetics, safety and tolerability of two formulations of XP23829 versus Biogen Idec Inc.’s (BIIB) Tecfidera (dimethyl fumarate) in healthy adult subjects. While the first formulation was administered as 400 mg twice per day (BID) without food, the second formulation was dosed as 800 mg once a day and 500 mg BID with food.
The results from the study revealed that both formulations had different PK profiles but were effective in producing MMF.
It was observed that the first formulation of the candidate had almost the same MMF as well as PK profile compared to the Tecfidera arm. However, the second formulation provided a more expanded exposure to MMF.
The results also showed that XP23829 was well tolerated and the adverse events were only mild to moderate in severity.
Xenoport also announced encouraging results from another open-label, pharmacokinetic and mass balance phase I study. The study evaluated twelve healthy subjects (males) across two cohorts of the same size.
The company expects a U.S. Food and Drug Administration (:FDA) meeting later this year after completing the phase I study.
Xenoport also announced the completion of a 13-week toxicology study of XP23829 conducted on three species, mouse, rat and primates. It was observed that the adverse effects of XP23829 were identical to that of Tecfidera controlled group apart from a few and milder adverse effects in the stomach experienced after the XP23829 dosage.
Xenoport carries a Zacks Rank #3 (Hold). Currently, companies which look attractive include Gilead Sciences Inc. (GILD) and Jazz Pharmaceuticals (JAZZ) with a Zacks Rank #1 (Strong Buy) and a Zacks Rank #2 (Buy), respectively.