BioSpecifics Technologies' partner Auxilium Pharmaceuticals (Auxilium) has dosed the first patient in its Phase IIa trial of Xiaflex (collagenase clostridium histolyticum or CCH) for the treatment of edematous fibrosclerotic panniculopathy (EFP), commonly known as cellulite.
In the US, 144 women between the ages of 18 and 45 will be enrolled in the randomised, double-blind multiple-dose Phase IIa trial.
Patients will be assessed for treatment efficacy by investigator and patient assessments, as well as 3D photographic imaging techniques.
The Phase IIa trial will be carried out in two stages and safety will be evaluated through the collection of adverse events, and if the safety and local tolerability profile from the first stage has been found to be acceptable, subjects will be enrolled in stage 2.
According to the company, topline results from the study are expected to be released in the first quarter of 2015.
In order to take part in the trial, participants must have EFP in the posterolateral thighs and/or buttocks for at least 12 months prior to a screening visit.
After screening and determination of eligibility, study participants will be assigned to one of four groups that vary in treatment dose such as low, medium, high and placebo.
During the trial, eligible participants will be randomised to low-dose XIAFLEX, mid-dose XIAFLEX, high-dose XIAFLEX, or placebo in a 5:5:5:3 ratio.
The company said total treatment doses for each treatment session include doses both lower and higher than the dose used in Dupuytren's contracture with a palpable cord.
According to the Phase Ib open label dose-ranging study, some doses of CCH provided improvement in the cellulite target dimple volume following a single injection into that dimple.
Cellulite, which occurs on the pelvic region, lower limbs and abdomen, has been reported to occur in 85%-98% of post-pubertal females and rarely in men.
Auxilium chief medical officer James Tursi said cellulite can affect the appearance of women's skin, causing undue bother and self-consciousness in some women.
"With many current treatment options not showing benefit and with no FDA approved options, we believe that CCH, if successful in clinical trials, could lead to the first FDA-approved, office-based biological treatment option for cellulite that is supported by scientific results," Tursi said.
While a Phase IIa trial of CCH for cellulite was initiated in the fourth quarter of 2013, Auxilium expects to initiate next stage trials of CCH for frozen shoulder syndrome in the same period.
BioSpecifics is currently engaged in the development of CCH for the treatment of human and canine lipomas, both of which are in Phase II studies, and expects to report top-line data from these trials by the end of 2013.
In addition, Swedish Orphan Biovitrum has marketing rights for Xiapex (the EU tradename for CCH) for the treatment of Dupuytren's contracture and Peyronie's disease in 71 Eurasian and African countries.
The FDA has also set a PDUFA date of December 6 for Xiaflex for Peyronie's disease.