Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as SAR442970
Brivekimig · 5 trials · 4 indications
Hidradenitis Suppurativa Clinical Response 75 (HiSCR75) is defined as ≥75% reduction from Baseline in the total abscess and inflammatory nodule \[AN\] count, with no increase from Baseline in abscess or draining tunnel count.
Clinical remission is defined as a mMS of 0 to 2, including Stool Frequency (SF) subscore of 0 or 1, Rectal Bleeding (RB) subscore of 0 and modified Mayo Endoscopic (mMES) of 0 or 1 confirmed by central reader (score of 1 does not include friability)
Endoscopic response is defined as decrease in Simple Endoscopic Score for Crohn's Disease (SES-CD) \>50% from baseline (or a decrease of at least 2 points for subjects with a baseline score of 4 or more and isolated ileal disease) based on central reading. The SES-CD evaluates 4 endoscopic variables (ulcer size, ulcerated surface, affected surface, and narrowing, each on a scale from 0 (none) to 3 in 5 segments assessed during ileocolonoscopy. The total score is the sum of the 4 endoscopic variable scores and ranges from 0 to 56, where higher scores indicate more severe disease.
Mixed meal tolerance test MMTT stimulated C-peptide concentration is to be calculated from area under the concentration-time curve (AUC)
The HiSCR50 was used for assessing HS treatment effectiveness in controlling inflammatory manifestations in the population. HiSCR50 was defined as \>=50% reduction from baseline in the total abscess and inflammatory nodule (AN) count, with no increase from baseline in abscess or draining tunnel count. Baseline was defined as the last available value before the first dose of DB study drug. Percentages are rounded off to the tenth decimal place.
| Arm | Type | Description |
|---|---|---|
| Brivekimig dose regimen A | EXPERIMENTAL | Participants will receive Brivekimig dose regimen A. |
| Brivekimig dose regimen B | EXPERIMENTAL | Participants will receive Brivekimig dose regimen B. |
| Brivekimig dose regimen C | EXPERIMENTAL | Participants will receive Brivekimig dose regimen C. |
| Placebo | PLACEBO_COMPARATOR | Participants will receive Brivekimig matching placebo. |
| SAR442970 Dose Regimen A | EXPERIMENTAL | Participants will receive SAR442970 dose regimen A |
| SAR442970 Dose Regimen B | EXPERIMENTAL | Participants will receive SAR442970 dose regimen B |
| Brivekimig | EXPERIMENTAL | Participants will receive subcutaneous injection of brivekimig. |
| SAR442970 | EXPERIMENTAL | Participants received SAR442970 once every two weeks (Q2W) in Period A (Day 1 to Week 16). Participants received SAR442970 Q2W in Period B (Up to Week 28). |
| Name | Type | Description |
|---|---|---|
| Brivekimig | DRUG | * Pharmaceutical form: Solution for injection in vial * Route of administration: Subcutaneous injection |
| Placebo | DRUG | * Pharmaceutical form: Solution for injection in vial * Route of administration: Subcutaneous injection |
| SAR442970 | DRUG | Route of administration: Subcutaneous |
Inclusion Criteria: * Participants with a diagnosis of moderate to severe hidradenitis suppurativa (HS) for at least 6 months prior to Baseline * Participants must have HS lesions present in at least 2 distinct anatomic areas (eg, left and right axilla; or left axilla and left inguinocrural fold), ...
Top 15 of 17 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Sanofi SA Sponsored ADR | SNY | 5 | PHASE3 | Duvakitug, balinatunfib, Brivekimig |
| AbbVie, Inc. | ABBV | 16 | PHASE3 | Upadacitinib, Risankizumab, Lutikizumab, Trosunilimab, ABBV-8736 |
| Eli Lilly and Company | LLY | 7 | PHASE3 | Mirikizumab, Tirzepatide, LY4395089, MORF-057 |
| Takeda Pharmaceutical Co. Ltd. Sponsored ADR | TAK | 15 | PHASE3 | Vedolizumab, Zasocitinib, Darvadstrocel |
| Johnson & Johnson | JNJ | 24 | PHASE3 | Ustekinumab, Guselkumab, JNJ-78934804, Golimumab, Icotrokinra |
| Merck & Co., Inc. | MRK | 2 | PHASE3 | Tulisokibart |
| AstraZeneca PLC | AZN | 2 | PHASE2 | AZD7798 |
| Spyre Therapeutics, Inc | SYRE | 2 | PHASE2 | SPY001, SPY002, SPY003 |
| Disc Medicine, Inc. | IRON | 1 | PHASE2 | DISC-0974 |
| Abivax SA Sponsored ADR | ABVX | 1 | PHASE2 | Obefazimod |
| Shattuck Labs, Inc. | STTK | 1 | PHASE2 | SL-325 |
| AgomAb Therapeutics NV ADR | AGMB | 2 | PHASE2 | Ontunisertib |
| Hoffmann-La Roche | RHHBY | 1 | PHASE2 | Afimkibart |
| Pfizer Inc. | PFE | 1 | PHASE2 | Etrasimod |
| Palisade Bio, Inc. | PALI | 1 | PHASE1 | PALI-2108 |
Brivekimig is an investigational small molecule developed by Sanofi for immune-mediated and inflammatory conditions. It is being studied in Phase 2 clinical trials for Crohn's disease, hidradenitis suppurativa, and type 1 diabetes mellitus. Brivekimig has not been approved for any indication and remains in clinical development.
Brivekimig is being studied for Crohn's disease, hidradenitis suppurativa, and type 1 diabetes mellitus. All three programs are in Phase 2. No approved use has been established, and the drug remains investigational across every indication under study.
Sanofi develops Brivekimig. Sanofi is a global pharmaceutical company traded on the Nasdaq under the ticker SNY. The company is running Phase 2 trials of Brivekimig across hidradenitis suppurativa, Crohn's disease, and type 1 diabetes mellitus.
Brivekimig is in Phase 2 clinical development. Sanofi is running Phase 2 studies in hidradenitis suppurativa, Crohn's disease, and type 1 diabetes mellitus. Brivekimig is investigational and has not been approved by the FDA or any other regulatory agency for any indication.
Brivekimig is being evaluated in three Phase 2 trials. NCT07170917 studies moderate to severe hidradenitis suppurativa and is recruiting 208 participants. NCT06958536 studies Crohn's disease and is recruiting 99 participants. NCT06812988 studies type 1 diabetes mellitus, is active but not recruiting, and enrolls 84 participants.
Brivekimig is an anti-OX40L bispecific with anti-TNF activity built in a single Nanobody molecule, so it targets both OX40 ligand and TNF. This dual targeting is designed to address inflammatory signaling in immune-mediated disease. The Phase 2 type 1 diabetes trial, NCT06812988, describes this mechanism directly in its title.