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news.Biopharmaceutical firm XenoPort said its XP23829 psoriasis drug showed frequent, gastrointestinal-related side effects in the phase 2 clinical trial.
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The company carried out the randomized, double-blind, placebo-controlled trial of XP23829 in 33 sites in the US in 200 subjects with moderate-to-severe chronic plaque-type psoriasis.
They were randomized to placebo or one of three treatment arms of XP23829: 400 mg or 800 mg once daily or 400 mg twice daily.
During the trial, adverse events related to diarrhea were 22% to 40% in the drug group, compared with 15% in the placebo group.
XenoPort said gastrointestinal events, which also included nausea, abdominal pain, vomiting and headache, were the most frequent side effects.
The company, however, said it expects to commence late-stage trials next year and explore possible partnerships to speed up the development of XP23829 globally.
XenoPort chief medical officer Richard Kim said: "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."
About 7.5 million Americans suffer from psoriasis. It is estimated that about 1.5 million adults in the US are considered to have moderate-to-severe psoriasis and between 150,000 and 260,000 new cases of psoriasis are diagnosed a year.