XenoPort, Inc. (XNPT) announced that it has commenced a multi-center, randomized, double-blind, placebo-controlled phase II study on its next-generation fumaric acid candidate, XP23829.
The study will evaluate the efficacy, safety and tolerability of XP23829 for treating patients suffering from moderate-to-severe chronic plaque-type psoriasis. Additionally, the study will assess the effect of dose and duration of treatment with XP23829 on potential reduction in psoriatic lesions and modulation of sub-populations of blood immune cells.
XenoPort intends to enroll about 200 patients in the study. Patients will receive either placebo or XP23829 in any one of the three doses − 400 mg or 800 mg once daily or 400 mg twice daily. The primary endpoint of the study will measure the percentage change in Psoriasis Area and Severity Index (PASI) score from baseline at the end of week 12. Top-line results should be out in the third quarter of 2015.
If successfully developed and commercialized, XP23829 will be an easy-to-use once daily treatment, thereby reducing flushing and gastrointestinal side effects. It might ensure more rapid onset and increased magnitude of efficacy for the treatment of psoriasis.
Psoriasis, according to XenoPort, is the most prevalent form of autoimmune disease in the U.S. Approximately 1.5 million adults in the U.S. suffer from moderate-to-severe psoriasis. Some drugs approved for psoriasis include Humira, Remicade and Stelara.
XenoPort said that results from the phase II study on XP23829, if positive, might act as a basis for advancing the candidate directly into phase III studies.
XenoPort carries a Zacks Rank #4 (Sell). Some better-ranked stocks in the biotech sector include Biogen Idec Inc. (BIIB), Regeneron Pharmaceuticals, Inc. (REGN) and Vical Inc. (VICL). All these stocks carry a Zacks Rank #1 (Strong Buy).
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