Auxilium Pharmaceuticals has dosed the first patient in its Phase IIb trial of collagenase clostridium histolyticum (CCH) for the treatment of adult patients with adhesive capsulitis, commonly known as frozen shoulder syndrome (FSS).
FSS is a painful condition caused by increased capsular collagen thickening and subsequent capsular contraction in the shoulder joint.
Around 2%-5% of the general adult population are expected to be affected by FSS and the full duration of the disease can last from about one year to up to 3.5 years.
In the US, the EU, Canada and Australia, CCH is approved for marketing as Xiaflex for the treatment of adult Dupuytren’s contracture (DC) patients with a palpable cord.
Xiaflex is a combination of two subtypes of collagenase, derived from Clostridium histolyticum. It is also approved in the US for non-surgical treatment of adult men with Peyronie’s disease (PD) with a palpable plaque.
Auxilium president and chief executive officer Adrian Adams said: "We believe that our continued measured investments in research and development, together with the upcoming product launches of Xiaflex in Peyronie’s disease and STENDRA in erectile dysfunction, position the Company well for growth and shareholder value creation," Adams added.
The double-blind, placebo-controlled Phase IIb study is designed to evaluate the safety and efficacy of CCH for the treatment of Stage 2 (frozen stage) unilateral idiopathic frozen shoulder.
Around 300 adult men and women will be enrolled in the trial, which will be carried out at 35 sites in the US and Australia.
The patients will be randomised 3:1 to receive CCH or placebo as well as receive up to three ultrasound-guided injections of study drug.
The company said that each injection will be separated by a minimum of 21 days and all patients will also perform home shoulder exercises after the first injection.
Auxilium chief medical officer James Tursi said FSS is a condition with no approved therapies and limited treatment options.
"Innovative treatment approaches such as CCH, if approved by the FDA, may allow patients quicker relief from limits in range of motion and associated pain," Tursi said.
Primary endpoint of the trial will be change in degrees from baseline to the Day 95 follow-up visit in active forward flexion in the affected shoulder compared to placebo.
In the trial, patients will also be evaluated using the ‘American Shoulder and Elbow Surgeons’ (ASES) scale for function and pain, as well as additional patient reported outcome measures.
According to the company, safety assessments will be made during all study visits and immunogenicity testing will be carried out at screening and at the end of the trial.
Image: The right shoulder and glenohumeral joint. Photo: courtesy of Phyzome.