Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
fresolimumab · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| fresolimumab 1 mg/kg total body weight | EXPERIMENTAL | - |
| fresolimumab 4 mg/kg total body weight | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| fresolimumab | DRUG | 1 mg/kg total body weight administered intravenous (IV) |
| Placebo | DRUG | Placebo administered to match active treatment group |
Inclusion Criteria: * The patient's renal biopsy is consistent with the diagnosis of primary Focal Segmental Glomerulosclerosis (FSGS) including all histological subtypes. * The patient has an eGFR ≥ 30 mL/min/1.73 m2 * The patient has a urinary total protein:creatinine ratio ≥ 3 mg protein/mg crea...
Fresolimumab has been studied for the treatment of primary focal segmental glomerulosclerosis (FSGS), a kidney disorder in the nephrology therapeutic area. The clinical program focused on patients with steroid-resistant primary FSGS. It is an investigational therapy and is not an approved treatment for this or any other indication.
Fresolimumab targets TGFB1, TGFB2, and TGFB3, the three isoforms of transforming growth factor beta. It is a monoclonal antibody that acts as an inhibitor of these targets. By binding all three TGF-beta isoforms, it is designed to block TGF-beta signaling, a pathway implicated in the scarring process in FSGS.
Fresolimumab is being developed by Sanofi, which trades on the New York Stock Exchange under the ticker SNY. Sanofi sponsored the clinical study of fresolimumab in steroid-resistant primary focal segmental glomerulosclerosis.
Fresolimumab is in Phase 2 development. It is an investigational monoclonal antibody and has not been approved by the FDA. The Phase 2 study in steroid-resistant primary focal segmental glomerulosclerosis has been completed, and no trials of fresolimumab are currently active.
Fresolimumab has been evaluated in one clinical trial, NCT01665391, titled A Study of Fresolimumab in Patients With Steroid-Resistant Primary Focal Segmental Glomerulosclerosis (FSGS). This completed Phase 2 trial enrolled 36 patients across the United States, Brazil, Germany, Italy, and Spain. It was randomized, double-blind, and placebo-controlled.