BioSpecifics Technologies Corp. has presented additional data from the phase III clinical programme of Xiaflex for the treatment of Peyronie's disease. The data was conducted by BioSpecifics’ partner Auxilium Pharmaceuticals, Inc. (Auxilium) and known as IMPRESS (The Investigation for Maximal Peyronie's Reduction Efficacy and Safety Studies).
These data will be presented at two oral presentations at the Sexual Medicines Society of North America (SMSNA)/International Society for Sexual Medicine (ISSM) Joint Annual Meeting on August 27 and 29, 2012 in Chicago, Illinois.
“These data highlight the psychological severity of this condition, which currently has no FDA-approved pharmaceutical therapy, and complement the positive top-line phase III results from the two IMPRESS clinical trials that we reported in June,” commented Thomas L Wegman, president of BioSpecifics. “We are excited about the potential for Xiaflex as the first and only biologic therapy for the treatment of Peyronie’s disease and we look forward to Auxilium’s submission of the sBLA filing to the FDA by the end of this year.”
Peyronie's disease can be a physically and psychosocially devastating disorder that may result in deformity of the penis, sexual dysfunction, pain, emotional distress, and loss of self-esteem and depression. To measure the impact of Peyronie's disease on a patient, the IMPRESS clinical trials utilized a proprietary Peyronie's Disease Questionnaire (PDQ) developed with the US Food and Drug Administration (FDA). One domain of the PDQ is patient bother, which is the patient-reported bother relating to various aspects of Peyronie’s disease including pain or discomfort with erection, appearance of the erect penis, difficulty when attempting intercourse and less frequent intercourse.
The analysis to be presented at the SMSNA/ISSM meeting focuses on the level of patient bother associated with Peyronie's disease as related to the degree of curvature deformity. As reported by Auxilium:
At baseline, results showed that all degrees of curvature deformity evaluated in the studies may be associated with high levels of bother and distress.
Specifically, more than half (58 per cent) of patients with lesser levels of curvature deformity (30 to 60 degrees) reported that they were “very bothered” or “extremely bothered” about their condition.
Additional results showed that 73 per cent of patients with curvature deformity of 60 to 90 degrees were also “very bothered” or “extremely bothered” about their condition.
A high level of patient-reported moderate to severe distress over Peyronie’s disease was also noted among subjects with curvature deformity of 30 to 60 or 60 to 90 degrees (80.5 per cent and 90.5 per cent, respectively).
These data will be presented at the SMSNA/ISSM meeting by Dr. Larry Lipshultz, entitled “Relationship of Baseline Penile Curvature Deformity Severity and Symptom Bother Observed in Patients with Peyronie's Disease” on August 29, 2012.
In addition, photographs and data will presented from a subset of IMPRESS patients involved in the first study ever to use 3-D photographic technology for 360 degree assessment of penile curvature deformity in PD patients. The sub-study was conducted as part of an open-label phase III study allowing physicians to visualize the changes in penile curvature deformity for a patient after each Xiaflex treatment cycle, including images from the patient's perspective. Patients were followed for 36 weeks and penile curvature deformity was 3-D photographed prior to each treatment cycle and at the end of the study. The results from this open-label sub-study were consistent with the double-blind placebo-controlled studies.
These data were presented at the SMSNA/ISSM meeting by Dr Ridwan Shabsigh, entitled “ThreeDimensional Imaging to Document Improvement in Penile Curvature Deformity in Patients with Peyronie's disease Treated in a phase III Study With Collagenase Clostridium Histolyticum” on August 27, 2012.
Auxilium expects to file a supplemental Biologics License Application (sBLA) with the FDA for Xiaflex in the treatment of Peyronie’s disease by the end of 2012. If approved by the FDA, Xiaflex is expected to be the first and only biologic therapy indicated for this condition.
IMPRESS is Auxilium's late stage global development plan for Xiaflex and consists of four clinical studies. Results from the two randomized, double-blind, placebo-controlled phase III studies, IMPRESS I and II, were announced in June 2012 and demonstrated statistically significant improvements in both co-3 primary endpoints of the trials, including percent improvement from baseline in penile curvature deformity compared to placebo and change from baseline (improvement) in the Peyronie's disease bother domain of Auxilium’s PDQ compared to placebo. These two studies enrolled over 800 patients combined at 64 sites in the US and Australia in less than five months, with a 2:1 ratio of Xiaflexto placebo.
There is also one open label study, which enrolled at least 250 patients, at approximately 30 sites in the US, EU and New Zealand, and one pharmacokinetic study, which enrolled approximately 20 patients who were then enrolled into the open label study. Xiaflex was administered two times a week every six weeks for up to four treatment cycles (2 x 4). Each treatment cycle was followed by a penile modeling procedure. Patients were followed for 52 weeks post-first injection in the double-blind studies and will be followed for 36 weeks in the open label and pharmacokinetic trials.
Peyronie's disease is characterized by the presence of inelastic collagen on the shaft of the penis, which can cause the penis to curve during erection, and may make sexual intercourse difficult or impossible in advanced cases. Significant psychological distress is common among sexually active patients with Peyronie's disease. Currently, there are no FDA-approved pharmaceutical therapies for this condition.