Between patients already enrolled and those presently in screening, Innovation has reached over 70 percent of the anticipated number of trial participants in its Phase 2b trial of Prurisol for the treatment of moderate-to-severe chronic plaque psoriasis. Recruitment trended slower than projected due to competition from other companies also testing psoriasis drugs. To expedite enrollment, the Company has added additional investigator sites, with a total of 28 sites now actively recruiting patients, and expects interim analysis, with top-line results, to be completed in 3Q2017.
Innovation believes it is an opportune time to be developing an oral treatment for psoriasis. Currently approved treatment options, including injectable biologics, are limited, with many options costly, not easily administered, associated with undesirable side effects and/or diminishing effectiveness over time. A novel psoriasis drug, particularly one that is oral, safe and effective, which could expand patient and physician choices for treatment, likely would command considerable market value. In Prurisol (abacavir glycolate), should clinical studies continue to meet their primary endpoints, Innovation potentially has just such a drug candidate.
Moreover, by utilizing the 505(b)(2) development approach, Prurisol development may benefit from an abbreviated regulatory pathway, thereby significantly shortening development time and reducing costs. With this approach, the FDA can rely on existing safety data of an already approved drug, in this instance, Ziagen (abacavir sulfate). In written comments provided to the Company in December 2014, the FDA directly addressed Prurisol’s safety pathway, stating, in part, that if Prurisol “… is shown to have lower or the same bioavailability of Ziagen, then long-term safety data will not be required.”