Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
EN3835 · 4 trials · 5 indications
Proportion of participants reporting AE during the study assessed by incidence, severity and duration
Number of of 2-level Clinician-Reported Photonumeric Cellulite Severity Scale (CR-PCSS) / Patient-Reported Photonumeric Cellulite Severity Scale (PR-PCSS) composite responders in the target buttock at Day 71. CR-PCSS and PR-PCSS is a 5-level scale ranging from "0" (None) to "4" (Severe). A participant who missed one or two assessments of CR-PCSS and PR-PCSS at Day 71 was defined as a non-responder. A 2-level composite responder is defined as a participant with an improvement from baseline of at least 2-levels of severity in the CR-PCSS and an improvement from baseline of at least 2-levels of severity in the PR-PCSS of the target buttock.
Adapted ASES is a self-administered participant reported outcome measure, divided into 2 sections: pain and function. Pain subscale is a single item, 11-point numeric rating scale, ranging from 0 (no pain at all) to 10 (worst pain), calculated as 10 - pain raw score and multiplying by 5, score ranging from 0 (worst pain) to 50 (no pain). Function subscale consists of 10 activities, 4-point ordinal scale about their ability to do the activity with the affected arm, ranging from 0 (unable to do) to 3 (not difficult), calculated by multiplying total score for 10 items by 5 and then dividing it by 3, score range of 0 (no function) to 50 (full function). Adapted ASES composite score is the sum of the pain subscale score (50% of the composite score) and function subscale score (50% of the composite score), score range of 0 (worst pain) to 100 (least pain). Positive change from Baseline score means an improvement in pain and/or shoulder function.
| Arm | Type | Description |
|---|---|---|
| EN3835 | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Observation Only Group | NO_INTERVENTION | - |
| Treated or Retreated Group | EXPERIMENTAL | - |
| EN3835 Active | ACTIVE_COMPARATOR | EN3835 0.84mg (Collagenase Clostridium Histolyticum) |
| Name | Type | Description |
|---|---|---|
| EN3835 | BIOLOGICAL | Biologic: EN3835 injection |
| Placebo | OTHER | Placebo injection |
Key Inclusion Criteria: * Be an ambulatory male or female ≥18 years of age. * Have a diagnosis of PFI. * Have current foot pain due to PFI. * Agree not to use prohibited medication, throughout the study, and not use any medication to treat PFI pain, except as permitted per the protocol. * If female...
EN3835 is an investigational small molecule being developed for Edematous Fibrosclerotic Panniculopathy (cellulite), Adhesive Capsulitis (frozen shoulder), and Plantar Fibromatosis (Ledderhose disease). It is in clinical development for these musculoskeletal conditions.
EN3835 is being developed by BrainsWay Ltd., a company traded under the ticker BWAY. The drug is currently in clinical trials for multiple musculoskeletal indications.
EN3835 is in Phase 2 and Phase 3 clinical trials. It is an investigational drug and has not been approved by the FDA. Completed trials include a Phase 2 study for frozen shoulder and Phase 3 studies for cellulite and plantar fibromatosis.
EN3835 has been studied in several completed trials, including NCT03428750 for cellulite, NCT04496167 for frozen shoulder, NCT05254457 for plantar fibromatosis, and NCT06151197 for plantar fibromatosis (Ledderhose disease). These trials were conducted in the United States and Puerto Rico.
EN3835 is being studied for the treatment of Plantar Fibromatosis, which is also known as Ledderhose disease. The drug is not the same as the disease itself, but it is an investigational treatment for this condition.