) 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
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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.
) 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.
) with a Zacks Rank #1 (Strong Buy) and a Zacks Rank #2 (Buy),