Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
AA4500 · 3 trials · 3 indications
measurement of erect penis at day 42 (cycle 2), day 84 (cycle 3), day 126 (cycle 4), day 168 (follow up visit 1) and day 252 (follow up visit 2)
Active range of motion (AROM) measurement using a goniometer to assess forward flexion in the affected shoulder
Maximum AUX-I (clostridial type I collagenase) enzyme concentration from pre-injection to 24 hours after Injection 1. AUX-I plasma concentrations were determined with a validated enzyme-linked immunosorbent assay (ELISA).
Maximum AUX-II (clostridium Type II collagenase) enzyme concentration from pre-injection to 24 hours after Injection 1. AUX-II plasma concentrations were determined with a validated enzyme-linked immunosorbent assay (ELISA).
Area under the curve from pre-injection to tlast within 24 hours after the Injection 1, where tlast is time to last time with a quantifiable concentration of the enzyme AUX-I. AUX-I plasma concentrations were determined with a validated enzyme-linked immunosorbent assay (ELISA).
Area under the curve from pre-injection to tlast within 24 hours after the Injection 1, where tlast is time to last time with a quantifiable concentration of the enzyme AUX-II. AUX-II plasma concentrations were determined with a validated enzyme-linked immunosorbent assay (ELISA).
Time to maximum AUX-I enzyme concentration. AUX-I plasma concentrations were determined with a validated enzyme-linked immunosorbent assay (ELISA).
Time to maximum AUX-II enzyme concentration. AUX-II plasma concentrations were determined with a validated enzyme-linked immunosorbent assay (ELISA).
Maximum AUX-I enzyme concentration from zero to 24 hours after Injection 2.AUX-I plasma concentrations were determined with a validated enzyme-linked immunosorbent assay (ELISA).
Maximum AUX-II enzyme concentration from zero to 24 hours after Injection 2. AUX-II plasma concentrations were determined with a validated enzyme-linked immunosorbent assay (ELISA).
Area under the curve from zero to tlast within 24 hours after the Injection 2, where tlast is time to last time with a quantifiable concentration of the enzyme AUX-I. AUX-I plasma concentrations were determined with a validated enzyme-linked immunosorbent assay (ELISA).
Area under the curve from zero to tlast within 24 hours after the Injection 2, where tlast is time to last time with a quantifiable concentration of the enzyme AUX-II. AUX-II plasma concentrations were determined with a validated enzyme-linked immunosorbent assay (ELISA).
Time to maximum AUX-I enzyme concentration. AUX-I plasma concentrations were determined with a validated enzyme-linked immunosorbent assay (ELISA).
Time to maximum AUX-II enzyme concentration. AUX-II plasma concentrations were determined with a validated enzyme-linked immunosorbent assay (ELISA).
| Arm | Type | Description |
|---|---|---|
| AA4500 with investigator modeling and vacuum therapy | ACTIVE_COMPARATOR | AA4500 with investigator modeling and home use of the ErecAid® Esteem® Manual Vacuum Therapy System. |
| AA4500 without investigator modeling/with vacuum therapy | ACTIVE_COMPARATOR | AA4500 without investigator modeling but with home use of the ErecAid® Esteem® Manual Vacuum Therapy System. |
| AA4500 0.29 mg/1 mL | EXPERIMENTAL | Up to three injections |
| AA4500 0.58 mg/2 mL | EXPERIMENTAL | Up to three injections |
| AA4500 0.58 mg/1 mL | EXPERIMENTAL | Up to three injections |
| AA4500 0.58 mg/0.5 mL | EXPERIMENTAL | Up to three injections |
| Shoulder exercises | OTHER | Home shoulder exercises for 64 days |
| AA4500 | EXPERIMENTAL | collagenase clostridium histolyticum (AA4500) contains purified collagenase AA4500 (clostridium histolyticum) consisting of two microbial collagenases in a defined mass ratio, Collagenase AUX-I and Collagenase AUX-II, which are isolated and purified from the fermentation of Clostridium histolyticum bacteria. 2 injections of AA4500 0.58 mg were administered 24 hours apart. |
| Name | Type | Description |
|---|---|---|
| AA4500 | BIOLOGICAL | - |
| ErecAid® Esteem® Manual Vacuum Therapy System | DEVICE | - |
| Investigator Modeling | PROCEDURE | - |
| AA4500 0.29 mg/1 mL | BIOLOGICAL | treatment of adhesive capsulitis |
| AA4500 0.58 mg/2 mL | BIOLOGICAL | treatment of adhesive capsulitis |
| AA4500 0.58 mg/1 mL | BIOLOGICAL | treatment of adhesive capsulitis |
| AA4500 0.58 mg/0.5 mL | BIOLOGICAL | treatment of adhesive capsulitis |
| Shoulder exercises | OTHER | Home shoulder exercises, minimum of 3 times per day |
Inclusion Criteria: * Be a male ≥ 18 years of age * Have symptom(s) of Peyronie's disease and have evidence of stable disease as determined by the investigator * Have penile curvature of at least 30° in the dorsal, lateral, or dorsal/lateral plane at screening. It must be possible to delineate the ...
AA4500 is an investigational drug being studied for Peyronie's Disease and Adhesive Capsulitis, also known as frozen shoulder. It is in Phase 2 clinical development for these musculoskeletal conditions. The drug is not approved and remains under investigation in clinical trials.
AA4500 is being developed by BrainsWay Ltd., a company traded under the ticker BWAY. The drug is in Phase 2 clinical trials for musculoskeletal indications, including Peyronie's Disease and Adhesive Capsulitis.
AA4500 is in Phase 2 clinical development. It has completed two Phase 2 trials, one in Peyronie's Disease and one in Adhesive Capsulitis. The drug is investigational and has not been approved by regulatory authorities.
AA4500 has completed two Phase 2 trials: NCT01430169, a pharmacokinetic study in men with Peyronie's Disease, and NCT01483963, a study for Adhesive Capsulitis of the shoulder. Both trials were conducted in the United States and have been completed.
AA4500 is classified as a monoclonal antibody modality. It is being investigated for Peyronie's Disease and Adhesive Capsulitis. The drug is in Phase 2 clinical development and is not yet approved for any use.