Xenoport Inc. (XNPT) made waves in Tuesday morning’s premarket trading session on news of positive clinical trial results. The company announced positive preliminary top-line results from its Phase 2 clinical trial of XP23829 as a potential treatment for moderate-to-severe chronic plaque-type psoriasis.
Xenoport is a biopharmaceutical company focused on developing and commercializing a portfolio of internally discovered product candidates for the potential treatment of neurological disorders.
Basically, XP23829 met its primary endpoint in both 800 mg once daily and 400 mg twice daily doses, demonstrating statistically significant improvements in percentage change from baseline to week 12 in Psoriasis Area and Severity Index (PASI) score.
Richard Kim, M.D., chief medical officer of XenoPort, commented on the release:
We believe these clinical data demonstrate for the first time that a MMF prodrug other than dimethyl fumarate (DMF) can be effective in reducing lesions in psoriatic patients. The magnitude of XP23829’s effect on the primary efficacy endpoint met our expectations for this relatively short duration trial and we are particularly encouraged by the results with 800 mg once-daily dosing. Based on what is known about fumarates, we believe that the efficacy of XP23829 is likely to improve with a more extended duration of treatment beyond 12 weeks. We are also pleased with the safety and tolerability profile of XP23829 emerging from this study. We believe that this demonstration of efficacy, safety and tolerability of XP23829 could lead to a differentiated product in psoriasis. We also believe that there is potential for the observations from this study to read through to other potential indications such as multiple sclerosis (MS).
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In the future, Xenoport noted that it plans to share its data on psoriasis with multiple experts and regulatory authorities. The goal is to support Phase 3 development, and ultimately initiate Phase 3 studies in 2016.
Shares of Xenoport closed Monday down 5.7%, at $6.73 in its 52-week trading range of $5.11 to $9.60. In early trading indications Tuesday, shares were up 6.2% at $7.15. The stock has a consensus analyst price target of $11.50.