This study will evaluate the safety and effectiveness of AA4500 in improving the impact of Peyronie's disease on quality of life and improving penile curvature in men with Peyronie's disease

A Phase 2b randomized, double-blind, placebo-controlled study of AA4500 in the treatment of subjects with Peyronie's disease.

During the screening period, subjects will have a physical examination including body weight and height, vital sign measurements, a 12-lead electrocardiogram (ECG), and clinical laboratory testing. Medical history, prior and concomitant medications, and demographic data will be recorded.

Inclusion Criteria:

• Heterosexual male ≥ 18 years of age
• In a stable relationship with a partner/spouse for at least 3 months before screening
• Have a diagnosis of Peyronie's disease for at least 6 months before first dose of study drug
• Have a penile curvature of at least 30° in the dorsal, lateral, or dorsal/lateral plane.
• Have functional difficulty related to Peyronie's disease (eg, difficulty with intromission or erectile dysfunction)
• Be judged to be in good health based upon the results of medical history, physical examination and laboratory profile
• Voluntarily sign an informed consent agreement approved by the Institutional Review Board/Independent Ethics Committee (IRB/IEC)
• Be able to complete and understand the various rating instruments

Exclusion Criteria:

• Have had an average of three successive blood pressure readings ≥ 160/100 mmHg during screening or the Day 1 assessments
• Severe pain during penile palpation

• Any of the following conditions:

  • Chordee in the presence or absence of hypospadias
  • Thrombosis of the dorsal penile artery
  • Infiltration by a benign or malignant mass resulting in penile curvature
  • Infiltration by an infectious agent, such as lymphogranuloma venereum
  • Ventral curvature from any cause
  • Presence of sexually transmitted disease
  • Known Hepatitis B or C
  • Known immune deficiency disease or be positive for human immunodeficiency virus (HIV)
• Previously undergone surgery for Peyronie's disease
• Penile curvature of less than 30° or greater than 90°
• Received alternative medical therapies for Peyronie's disease administered by the intralesional route (including, but not limited to, steroids, verapamil, and the naturally occurring low molecular weight protein, interferon-α2b) within 3 months before the first dose of study drug or plans to use any of these medical therapies at any time during the study
• Received alternative medical therapies for Peyronie's disease administered by the oral (including, but not limited to, vitamin E (>500IU), potassium aminobenzoate [Potaba], tamoxifen, colchicine, pentoxifylline, over-the-counter erectile dysfunction medications, or steroidal anti inflammatory drugs) or topical routes (including, but not limited to, verapamil applied as a cream) within 4 weeks before the first dose of study drug or plans to use any of these medical therapies at any time during the study
• Used any mechanical type device for correction of Peyronie's disease within the 2-week period before screening or plans to use any these devices at any time during the study
• Used a mechanical device to induce a passive erection within the 2-week period before screening or plans to use any of these devices at any time during the study
• Significant erectile dysfunction that has failed to respond to oral treatment with phosphodiesterase type 5 (PDE5) inhibitors
• Recent history of stroke, bleeding, or other medical condition, which in the investigator's opinion would make the subject unsuitable for enrollment in the study
• Unwilling or unable to cooperate with the requirements of the study including completion of all scheduled study visits
• Received an investigational drug or treatment within 30 days before the first dose of study drug
• Allergy to collagenase or any other excipient of AA4500
• Allergy to any concomitant medication required as per the protocol
• Received anticoagulant medication (except for ≤ 165 mg aspirin daily or ≤ 800 mg of over-the-counter NSAIDS daily) during the 7 days before each dose of study drug
• Received doxycycline or a tetracycline derivative during the 7 days before each dose of study drug or plans to use these drugs within 2 days after the injection of study drug
• Received any collagenase treatments within 30 days of the first dose of study drug