Xanelim effective in psoriasis; Ph III data

Genentech and Xoma have said that their jointly-developed drug forpsoriasis, Xanelim (efalizumab), has met its endpoints at the interim stage of two Phase III trials and is on track to be filed for approval in the USA later this year or early in 2002. Xanelim is a humanized anti-CD11 monoclonal antibody which is delivered by subcutaneous injection once a week, and represents a completely new therapeutic approach to the management of psoriasis.

The 12-week data from the ongoing pivotal studies in patients with moderate-to-severe plaque psoriasis indicate that, in both trials, Xanelim met the primary endpoint, a significant difference in the percentage of patients achieving a 75% or greater improvement in the Psoriasis Area and Severity Index compared to placebo. Both trials enrolled patients with psoriasis covering at least 10% of their total body area who were randomized to receive Xanelim at a dose of 1mg/kg/week or 2mg/kg/week, or placebo, for 12 weeks. The drug was generally well-tolerated in the trials, with the most commonly-observed adverse events including headache, nausea, chills and pain.

The studies are continuing with a re-treatment and observation phase of up to six months, to see if the benefits of Xanelim are sustained. A full analysis of the data should be available within the next several months, according to the two companies. Meantime, an additional study looking at use of Xanelim for up to one year is ongoing.