EmailAuxilium Pharma (AUXL $20.77 +1.92) announced positive top-line results from its IMPRESS trials, the phase III studies that assessed XIAFLEX. In IMPRESS I at 52 weeks, the co-primary endpoints met statistical significance with a 37.6% mean reduction in penile curvature deformity for XIAFLEX subjects and a 3.3 point (44%) improvement in the Peyronie's Disease Questionnaire bother domain for XIAFLEX subjects. In IMPRESS II at 52 weeks, the co-primary endpoints met statistical significance with a 30.5% mean improvement in penile curvature deformity for XIAFLEX subjects and a 2.4 point (32.4%) improvement in the PDQ bother domain for XIAFLEX subjects. XIAFLEX was generally well-tolerated.
The most common treatment related adverse events reported in the phase III studies were local to the treatment site and consistent with adverse events reported in previous PD trials with XIAFLEX, which included injection site hematoma, pain and swelling. If approved by the FDA, XIAFLEX is expected to be the first and only approved biologic therapy indicated for the treatment of PD.
