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SAR156597 · 3 trials · 2 indications
mRSS, an accepted clinical measure of the skin thickness (fibrosis). Investigator physicians or qualified medical personnel assessed the thickening of skin in 17 skin sites including fingers, hands, forearms, arms, feet, legs and thighs, face, chest and abdomen. Each skin site was rated on a 0-3 scale; where 0 = normal skin, 1 = mild thickness, 2 = moderate thickness and 3 = severe thickness. Total mRSS ranged from 0 (no thickening) to 51 (severe thickening in all 17 areas), where higher score indicated more severity of skin thickening/worst outcome.
FVC is a standard pulmonary function parameter measured by spirometry and used to quantify respiratory capacity (inspiration and expiration). It is a widely used objective measure of disease status in participants with Idiopathic Pulmonary Fibrosis (IPF). The primary variable was recorded as percent (%) of predicted value, which takes into account the height, gender, and age of the participant. The outcome measure measured the change in lung function from baseline at week 52.
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | Placebo (for SAR156597), single subcutaneous (SC) injection once in a week (QW) up to Week 24. |
| SAR156597 | EXPERIMENTAL | SAR156597 200 milligram (mg), single SC injection QW up to Week 24. |
| Placebo qw | PLACEBO_COMPARATOR | Participants received one injection of placebo (matched to SAR156597) subcutaneously once every week (qw) for 52 weeks. |
| SAR156597 200 mg q2w | EXPERIMENTAL | Participants received one injection of SAR156597 200 mg subcutaneously once every 2 weeks (q2w) alternating with placebo (matched to SAR156597) for 52 weeks. |
| SAR156597 200 mg qw | EXPERIMENTAL | Participants received one injection of SAR156597 200 mg subcutaneously qw for 52 weeks. |
| SAR156597 dose 1 | EXPERIMENTAL | SAR156597 dose 1, subcutaneous injection once every week |
| SAR156597 dose 2 | EXPERIMENTAL | SAR156597 dose 2, subcutaneous injection once every week |
| SAR156597 dose 3 | EXPERIMENTAL | SAR156597 dose 3, subcutaneous injection once every week |
| Name | Type | Description |
|---|---|---|
| SAR156597 | DRUG | Pharmaceutical form: Solution Route of administration: Subcutaneous |
| Placebo | DRUG | Pharmaceutical form: Solution Route of administration: Subcutaneous |
| Placebo (for SAR156597) | DRUG | Pharmaceutical form: solution Route of administration: subcutaneous |
Inclusion criteria : * Systemic Sclerosis (SSc) according to the American College of Rheumatology/The European League against Rheumatism (ACR/EULAR) 2013 criteria. * Diffused cutaneous form of SSc according to Leroy's criteria. * Able and willing to sign the written informed consent form with compr...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Bristol-Myers Squibb Company | BMY | 2 | PHASE3 | BMS-986278 |
| United Therapeutics Corporation | UTHR | 2 | PHASE3 | Treprostinil |
| AbbVie, Inc. | ABBV | 2 | PHASE2 | ABBV-142 |
| PureTech Health PLC Sponsored ADR | PRTC | 2 | PHASE3 | Deupirfenidone, Pirfenidone |
| Syndax Pharmaceuticals Inc | SNDX | 1 | PHASE2 | Axatilimab |
| Contineum Therapeutics, Inc. Class A | CTNM | 1 | PHASE2 | PIPE-791 Dose A, PIPE-791 Dose B |
| Rein Therapeutics, Inc | RNTX | 1 | PHASE2 | LTI-03 |
| Sunshine Biopharma Incorporated | SBFM | 2 | PHASE3 | HEC585, Pirfenidone |
| Cumberland Pharmaceuticals Inc. | CPIX | 1 | PHASE2 | Ifetroban |
| Avalyn Pharma Inc | AVLN | 3 | PHASE2 | AP01 |
SAR156597 is an investigational small molecule being studied for the treatment of Idiopathic Pulmonary Fibrosis and Systemic Sclerosis. It has been evaluated in clinical trials for these conditions, though it remains in clinical development and is not approved.
SAR156597 is being developed by Sanofi, a global biopharmaceutical company listed on the stock exchange under the ticker SNY. Sanofi has sponsored clinical trials to evaluate the drug's safety and efficacy in patients with fibrotic diseases.
SAR156597 has completed Phase 2 clinical trials. It is an investigational drug, meaning it is not yet approved by regulatory authorities. The completed trials include a Phase 1 study and two Phase 2 studies, with no active trials currently ongoing.
SAR156597 has been studied in three completed clinical trials. NCT01529853 was a Phase 1 study in Idiopathic Pulmonary Fibrosis with 24 participants. NCT02345070 was a Phase 2 efficacy and safety trial in Idiopathic Pulmonary Fibrosis with 327 participants. NCT02921971 was a Phase 2 trial in Systemic Sclerosis with 97 participants.
SAR156597 is the primary name for this investigational drug. No alternative names have been reported in the clinical trial data. It is a distinct small molecule being developed by Sanofi for fibrotic conditions.