BioSpecifics Technologies Corp. (BSTC) announced positive, statistically significant top-line data from the Phase IIa study of XIAFLEX for the potential treatment of frozen shoulder (adhesive capsulitis).
The company stated that the data further support the vast potential of XIAFLEX for many conditions and diseases caused by collagen accumulation, in addition to the five indications in clinical development and the sBLA under review at the FDA for XIAFLEX for Peyronie's disease.
The company said that its strategic partner Auxilium Pharmaceuticals Inc. (AUXL) conducted the open-label, controlled dose-ranging Phase IIa study. The study was designed to assess the safety and efficacy of XIAFLEX for the treatment of Stage 2 unilateral idiopathic frozen shoulder in comparison to an exercise-only control group.
As reported by Auxilium, this study involved 50 adult men and women at 11 U.S. sites. Four cohorts of 10 patients each received up to three ultrasound-guided extraarticular injections of varying doses of XIAFLEX (ranging from 0.29mg to 0.58mg in three different volumes; 0.5, 1.0, or 2.0 mL), separated by a minimum of 21 days. All patients were instructed to perform home shoulder exercises. The fifth cohort of ten patients received no XIAFLEX injections and only performed home shoulder exercises.
The study's primary endpoint was the change (in degrees) from baseline to the day 92 follow-up in active forward flexion in the affected shoulder compared to the exercise-only cohort. Safety assessments were made during all study visits and immunogenicity testing was performed at screening and day 92.
According to the study results, Both the 0.58mg (1mL) and 0.58mg (2mL) dosing arms showed positive, statistically significant improvement from baseline in forward flexion vs. the exercise-only group. The 0.58mg (1mL) dosing arm also showed statistically significant improvement from baseline in shoulder abduction vs. the exercise-only group. Positive trends with improvement in degrees were also seen in other active range of motion (AROM) assessments vs. the exercise-only group. Twenty-nine study patients (72.5%) received three XIAFLEX injections with 5 subjects receiving two injections and 6 subjects receiving one injection only.
There were no drug-related serious adverse events reported and all treatment-related adverse events were consistent with XIAFLEX use in other approved and potential indications.
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