Auxilium Pharmaceuticals has reported positive top-line data from its open-label Xiaflex Phase IIIb Dupuytren’s Contracture multicord study.
The Phase IIIb trial, which enrolled 60 patients at eight sites throughout the US and Australia, evaluated Xiaflex for the treatment of adult Dupuytren’s contracture patients with multiple palpable cords.
Auxilium chief executive officer and president Adrian Adams said the company expects to begin a larger trial soon that, if successful, may allow it to seek expansion of the current Dupuytren’s indication for Xiaflex.
"We believe that physicians who treat Dupuytren’s and their prospective patients would be receptive to the potential ability to treat more affected joints at a single treatment session using a non-surgical treatment alternative," Adams added.
The patients received two concurrent injections of 0.58mg of Xiaflex per affected hand and efficacy was based on a single injection per contracted joint, in the trial.
At 30 days, 60% of all joints, 76% of metacarpophalangeal and 33% proximal interphalangeal joints achieved clinical success (defined as joint correction to 0 to 5 degrees) following the single injection when two 0.58mg doses of XIAFLEX were administered concurrently into the same hand.
The study reported that the response rates are numerically higher than the response rates seen after the first single injection in the double-blind placebo controlled Phase III studies.
The bruising, pain and swelling at the treatment site were the most common adverse events observed, which were comparable to the previous trials with certain events being slightly higher with two concurrent injections; bruising, pain, pruritus, and lymphadenopathy.