Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as SAR441566
balinatunfib · 7 trials · 4 indications
Clinical remission by modified Mayo score (mMS) is defined as a mMS ≤2 with no subscore \>1 (stool frequency \[SF\] of 0 or 1 with at least a 1-point decrease from baseline, rectal bleeding \[RB\] of 0 and modified Mayo Endoscopic Subscore \[mMES\] of 0 or 1 where 1 does not include friability). Each component of the mMS (SF, RB, and mMES) is scored from 0 to 3. The total mMS ranges from 0 to 9 with higher scores indicating greater disease severity.
ACR20 response criteria is a dichotomous composite endpoint indicating the proportion of participants with at least 20 percent improvement in the number of tender and swollen joints, and in three out of the remaining five ACR core-set measures: patient pain (VAS, No pain to Severe Pain), Patient Global Assessment of disease activity (VAS, Very well to Very Poor), physician global assessment of disease activity (VAS, Very good to Very bad), physical functioning assessment (Health Assessment Questionnaire-Disability Index \[HAQ-DI\]), and acute phase reactants (ESR or CRP mg/dl; in this study CRP will be used). ACR response is scored as a percentage improvement, comparing disease activity at two discrete time points. ACR20 is ≥ 20% improvement.
PASI is linear combination of percent of surface area of skin that is affected and severity of erythema(E),induration(i),desquamation(D) over 4 body regions: head(h),trunk(t),upper extremities(u),lower extremities(l). The signs of severity, E, i and D of lesions are assessed using numeric scale for which scores are made independently for each of the areas; range:0 (complete lack of cutaneous involvement) to 4 (severest possible involvement). For each body area, percentage of considered body area covered by plaque psoriasis is translated into numerical value "Ax":0=no involvement,1=\<10% to 6=90 to 100% involvement. These scores are noted Ah, At, Au, and Al in formula below. The PASI score is calculated according to the following formula: PASI = 0.1(Eh+ih+Dh)Ah + 0.3(Et+it+Dt)At + 0.2(Eu+iu+Du)Au + 0.4(El+il+Dl)Al. PASI score range:0 (no disease) to 72 (maximal disease);higher scores: greater psoriasis severity. Percentage of participants with PASI75 at Week 12 is presented.
The PI is calculated as the ratio of the minimal erythema dose (MEDbaseline) measured on Day -2 at 10 minutes post-irradiation to the corresponding MEDon-drug measured on Day 8 at 10 minutes post-irradiation. Condition 1 is Full range solar ultraviolet B/ultraviolet A (UVB/UVA) \[290 to 400 nm\] exposure.
The PI is calculated as the ratio of the minimal erythema dose (MEDbaseline) measured on Day -2 at 1 hour post-irradiation to the corresponding MEDon-drug measured on Day 8 at 1 hour post-irradiation. Condition 1 is full range solar UVB/UVA \[290 to 400 nm\] exposure.
The PI is calculated as the ratio of the minimal erythema dose (MEDbaseline) measured on Day -1 at 24 hours post-irradiation to the corresponding MEDon-drug measured on Day 9 at 24 hours post-irradiation. Condition 1 is a Full range solar UVB/UVA \[290 to 400 nm\] exposure.
The PI is calculated as the ratio of the minimal erythema dose (MEDbaseline) measured on Day -2 at 10 minutes post-irradiation to the corresponding MEDon-drug measured on Day 8 at 10 minutes post-irradiation. Condition 2 is a UVA only \[320 to 400 nm\] exposure.
The PI is calculated as the ratio of the minimal erythema dose (MEDbaseline) measured on Day -2 at 1 hour post-irradiation to the corresponding MEDon-drug measured on Day 8 at 1 hour post-irradiation. Condition 2 is a UVA only \[320 to 400 nm\] exposure.
The PI is calculated as the ratio of the minimal erythema dose (MEDbaseline) measured on Day -1 at 24 hours post-irradiation to the corresponding MEDon-drug measured on Day 9 at 24 hours post-irradiation. Condition 2 is a UVA only \[320 to 400 nm\] exposure.
Maximum plasma concentration observed
Area under the plasma concentration versus time curve calculated using the trapezoidal method from time zero to the real time Tlast (AUClast)
Area under the plasma concentration versus time curve extrapolated to infinity (AUC)
Assessment of adverse events (AE) / treatment-emergent adverse events (TEAE) including SAE and AESI
| Arm | Type | Description |
|---|---|---|
| CD cohort: balinatunfib dose regimen 1 | EXPERIMENTAL | Participants will receive balinatunfib dose regimen 1 |
| CD cohort: balinatunfib dose regimen 2 | EXPERIMENTAL | Participants will receive balinatunfib dose regimen 2 |
| CD cohort: balinatunfib dose regimen 3 | EXPERIMENTAL | Participants will receive balinatunfib dose regimen 3 |
| CD cohort: Placebo | PLACEBO_COMPARATOR | Participants will receive balinatunfib-matching placebo |
| UC cohort: balinatunfib dose regimen 1 | EXPERIMENTAL | Participants will receive balinatunfib dose regimen 1 |
| UC cohort: balinatunfib dose regimen 2 | EXPERIMENTAL | Participants will receive balinatunfib dose regimen 2 |
| UC cohort: balinatunfib dose regimen 3 | EXPERIMENTAL | Participants will receive balinatunfib dose regimen 3 |
| UC cohort: Placebo | PLACEBO_COMPARATOR | Participants will receive balinatunfib-matching placebo |
| SAR441566 dose regimen 1 | EXPERIMENTAL | Participants will receive SAR441566 dose regimen 1 |
| SAR441566 dose regimen 2 | EXPERIMENTAL | Participants will receive SAR441566 dose regimen 2 |
| SAR441566 dose regimen 3 | EXPERIMENTAL | Participants will receive SAR441566 dose regimen 3 |
| Placebo | PLACEBO_COMPARATOR | Participants will receive SAR441566-matching placebo |
| SAR441566 dose regimen A | EXPERIMENTAL | Participant will receive dose regimen A of SAR441566 for 12 weeks |
| SAR441566 dose regimen B | EXPERIMENTAL | Participant will receive dose regimen B of SAR441566 for 12 weeks |
| SAR441566 dose regimen C | EXPERIMENTAL | Participant will receive dose regimen C of SAR441566 for 12 weeks |
| SAR441566 dose regimen D | EXPERIMENTAL | Participant will receive dose regimen D of SAR441566 for 12 weeks |
| SAR441566 dose regimen E | EXPERIMENTAL | Participants received dose regimen E of SAR441566 |
| Part I SAR441566 Dose A | EXPERIMENTAL | Participants will receive repeated low dose of SAR441566 for 7.5 days |
| Part I SAR441566 Dose B | EXPERIMENTAL | Participants will receive repeated high dose of SAR441566 for 7.5 days |
| Part I Placebo | PLACEBO_COMPARATOR | Participants will receive repeated SAR441566 matching placebo tablets for 7.5 days |
| Part II Ciprofloxacin | ACTIVE_COMPARATOR | Participants will receive repeated ciprofloxacin 500 mg twice-daily (BID) for 5.5 days |
| SAR441566 | EXPERIMENTAL | Participants will receive single ascending doses of SAR441566 on day 1 of each 8-12-day cycle |
| Name | Type | Description |
|---|---|---|
| balinatunfib | DRUG | Pharmaceutical form:Tablet -Route of administration:Oral |
| balinatunfib-matching placebo | DRUG | Pharmaceutical form:Tablet -Route of administration:Oral |
| SAR441566 | DRUG | Pharmaceutical form: Tablet Route of administration: Oral |
| SAR441566 matching Placebo | DRUG | Pharmaceutical form: Tablet Route of administration: Oral |
| Placebo | DRUG | Tablet |
| Ciprofloxacin | DRUG | Tablet |
Inclusion Criteria: Participants are eligible to be included in the study only if all of the following criteria apply: * Participants with Crohn's Disease (CD) or ulcerative colitis (UC) who completed treatment at Week 52 of the SPECIFI-CD (DRI18212) or SPECIFI-UC (DRI17822) studies, respectively:...
Balinatunfib is an investigational small molecule developed by Sanofi for inflammatory bowel disease. It is being studied in ulcerative colitis and Crohn's disease. It has not been approved by the FDA and remains in clinical development.
Balinatunfib is being developed for the treatment of ulcerative colitis and Crohn's disease, both gastrointestinal inflammatory conditions. Its only listed trial enrolls adults with either condition. It is investigational and is not approved for any use.
Balinatunfib is developed by Sanofi, which trades on the New York Stock Exchange under the ticker SNY. Sanofi is the sponsor of the clinical program evaluating the drug in inflammatory bowel disease.
Balinatunfib is in Phase 2 clinical development. It has one active Phase 2 trial that is no longer recruiting participants. The drug is investigational and has not received FDA approval.
Balinatunfib is being studied in the SPECIFI-IBD-LTS trial, registered as NCT07222189. This Phase 2 study is evaluating long-term safety, tolerability and efficacy in participants with Crohn's disease or ulcerative colitis. It is active but not recruiting, with planned enrollment of 325 participants across the United States, Argentina, Bulgaria, Chile, China, Czechia and Italy.
The NCT07222189 trial is a Phase 2, double-blind, placebo-controlled study of balinatunfib in adults aged 19 years and older with Crohn's disease or ulcerative colitis. It is not biomarker-selected and does not enroll healthy volunteers. The study is active but no longer recruiting, with a planned enrollment of 325 participants.