Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as brivekimig
SAR442970 · 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 |
|---|---|---|---|---|
| AbbVie, Inc. | ABBV | 5 | PHASE3 | Upadacitinib, Lutikizumab |
| Incyte Corporation | INCY | 6 | PHASE3 | povorcitinib, Ruxolitinib |
| Novartis AG Sponsored ADR | NVS | 14 | PHASE3 | Remibrutinib, Secukinumab |
| Sanofi SA Sponsored ADR | SNY | 3 | PHASE2 | Duvakitug, Brivekimig, SAR445399 |
| MoonLake Immunotherapeutics Class A | MLTX | 2 | PHASE3 | Sonelokimab |
| Pfizer Inc. | PFE | 1 | PHASE2 | Ritlecitinib |
| Merck & Co., Inc. | MRK | 1 | PHASE2 | Tulisokibart |
| Takeda Pharmaceutical Co. Ltd. Sponsored ADR | TAK | 1 | PHASE2 | Zasocitinib |
| Zura Bio Limited Class A | ZURA | 1 | PHASE2 | Tibulizumab |
| Regeneron Pharmaceuticals, Inc. | REGN | 1 | PHASE2 | Olatorepatide |
| Spyre Therapeutics, Inc | SYRE | 1 | PHASE2 | SPY072 |
| Oruka Therapeutics, Inc. | ORKA | 1 | PHASE2 | ORKA-002 |
| Kymera Therapeutics, Inc. | KYMR | 1 | PHASE1 | SAR447971 |
| Evommune, Inc. | EVMN | 1 | EARLY_PHASE1 | EVO101 |
| Corvus Pharmaceuticals, Inc. | CRVS | 1 | PHASE1 | Soquelitinib |
SAR442970 is an investigational small molecule being developed by Sanofi for hidradenitis suppurativa and ulcerative colitis. It is in Phase 2 clinical development for both indications, with one completed Phase 2 study in hidradenitis suppurativa and one active Phase 2 study in ulcerative colitis.
SAR442970 is developed by Sanofi, which trades on the New York Stock Exchange under the ticker SNY. Sanofi is running the clinical program for SAR442970 across dermatology and gastroenterology indications, including hidradenitis suppurativa and ulcerative colitis.
SAR442970 is in Phase 2 clinical development. A Phase 2 trial in hidradenitis suppurativa has been completed, and a Phase 2 trial in ulcerative colitis is active but no longer recruiting. SAR442970 is investigational and has not been approved by the FDA for any indication.
SAR442970 has been studied in two Phase 2 trials. NCT05849922 tested SAR442970 in adults with hidradenitis suppurativa and is completed, enrolling 86 participants. NCT06975722 is evaluating brivekimig in adults with ulcerative colitis, is active and not recruiting, and enrolled 105 participants across the United States, Europe, Australia, China, and Japan.
Yes, brivekimig is another name for SAR442970. The Phase 2 ulcerative colitis trial NCT06975722 refers to the drug as brivekimig, while the completed Phase 2 hidradenitis suppurativa trial NCT05849922 refers to it as SAR442970. Both names describe the same Sanofi investigational small molecule.
NCT06975722 is a Phase 2, randomized, double-blind, placebo-controlled study of SAR442970 in adults 18 years and older with ulcerative colitis. It enrolled 105 participants and is active but not recruiting. The study is running in the United States, Australia, China, Czechia, France, Germany, Hungary, Japan, Moldova, Poland, Spain, and the United Kingdom.