Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Obefazimod · 2 trials · 2 indications
Change from baseline in Crohn's Disease Activity Index (CDAI) score at Week 12 and Week 52 The CDAI total score ranges from 0 to over 600. Higher scores mean a worse outcome.
Change from baseline in Simple Endoscopic Score for Crohn's disease (SES-CD) at Week 52 The SES-CD is an endoscopic grading system that consists of a composite score based on 4 components: the size of mucosal ulcers, the extent of the ulcerated surface, the endoscopic extension, and the presence of stenosis (26). Each of the 4 SES-CD components are assessed in the 5 segments of the ileum and colon: ileum, right, transverse, left, and rectum. The SES-CD is the sum of the individual scores of each of the components across the 5 segments. The total score ranges from 0 to 60. Higher scores mean a worse outcome
Proportion of subjects with endoscopic response at Week 52
Proportion of subjects with no SES-CD ulcer subscore \> 1 in at least one segment at Week 52
Proportion of subjects with CDAI clinical remission at Week 52 Proportion of subjects with sustained CDAI clinical remission at Week 52
Proportion of subjects with patient reported outcome (PRO)-2 clinical remission at Week 52
Proportion of subjects with CDAI clinical response (CDAI decrease from baseline ≥ 100 points) at Week 52
Proportion of subjects with PRO-2 clinical response (≥ 30% decrease in average daily PRO-2 score (AP + SF) and both no higher than baseline) at Week 52
Proportion of subjects with CDAI clinical response and endoscopic response at Week 52
Proportion of subjects with endoscopic remission at Week 52
Incidence of all treatment-emergent adverse events (TEAEs), serious adverse events (SAEs) and causally related TEAEs/SAEs Incidence of adverse events (AEs) leading to discontinuation
Number of patients with clinically-significant abnormal laboratory parameters. Hematology: Hematocrit, hemoglobin, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration, mean corpuscular volume, platelet count, red blood cells; white blood cells Coagulation: International normalized ratio, activated partial thromboplastin time, fibrinogen, prothrombin time
Number of patients with clinically-significant abnormal laboratory parameters. Albumin, total protein, aspartate aminotransferase (AST), alanine transaminase (ALT), alkaline phosphatase (ALP), total bilirubin, gamma glutamyl transferase (GGT), lactate dehydrogenase (LDH), lipase, amylase, creatinine, creatinine clearance, urea, chloride, bicarbonate, sodium, potassium, calcium, phosphate, uric acid, glucose, total cholesterol, LDL cholesterol (direct), HDL cholesterol, triglycerides, creatine phosphokinase (CPK), high sensitivity troponin I and T, N-terminal prohormone of brain natriuretic peptide (NT-proBNP)
Cmax of obefazimod in the Minitablet and Capsule regimens
AUC (0-last) of obefazimod in the Minitablet and Capsule regimens
AUC(0-inf) of obefazimod in the Minitablet and Capsule regimens
| Arm | Type | Description |
|---|---|---|
| Obefazimod 50mg | EXPERIMENTAL | Obefazimod 50mg given once-daily (QD) in subjects with moderately to severely active Crohn's disease (CD) |
| Obefazimod 25mg | EXPERIMENTAL | Obefazimod 25mg given once-daily (QD) in subjects with moderately to severely active Crohn's disease (CD) |
| Obefazimod 12.5mg | EXPERIMENTAL | Obefazimod 12.5mg given once-daily (QD) in subjects with moderately to severely active Crohn's disease (CD) |
| Placebo | PLACEBO_COMPARATOR | Placebo given once-daily (QD) in subjects with moderately to severely active Crohn's disease (CD) |
| Obefazimod 50 mg Capsule Adult Formulation | EXPERIMENTAL | Participants will receive a single oral dose of obefazimod Capsule administered with water |
| Obefazimod Minitablet 50 mg | EXPERIMENTAL | Participants will receive a single oral dose of obefazimod Minitablet with either Apple sauce, Chocolate pudding, Yogurt, Water |
| Name | Type | Description |
|---|---|---|
| Obefazimod | DRUG | Obefazimod is administered once-daily in fed condition (ideally at the same time in the morning). |
| Placebo | OTHER | Matching placebo will be administered QD in fed condition (ideally at the same time in the morning). |
| Obefazimod 50 mg Capsule | DRUG | Adult formulation |
| Obefazimod Minitablet 50 mg | DRUG | Pediatric formulation |
Inclusion Criteria: 1. Male or female (at birth) 18 to 75 years old and able to understand, sign, and date the written voluntary informed consent at the visit prior to any protocol-specified procedures 2. Able and willing to comply with study visits and procedures as per protocol. 3. Confirmed and ...
Obefazimod is an investigational small molecule being studied for moderately to severely active Crohn disease. It is also being evaluated in healthy volunteers for pharmacokinetic studies. The drug is in clinical development and is not approved by regulatory authorities.
Obefazimod is a modulator that targets NCBP2 and NCBP1, which are nuclear cap-binding proteins. By modulating these targets, the drug may influence gene expression pathways relevant to inflammation in Crohn disease.
Obefazimod is being developed by Abivax SA, a biopharmaceutical company listed on the stock exchange under the ticker ABVX. The company is conducting clinical trials to evaluate the drug's safety and efficacy.
Obefazimod is in Phase 1 clinical development. It is being studied in a Phase 1 trial for healthy volunteers and a Phase 2 trial for Crohn disease, both of which are currently recruiting participants.
Obefazimod is being studied in two clinical trials. NCT06456593 is a Phase 2 trial in patients with moderately to severely active Crohn disease, enrolling 212 participants across multiple countries. NCT07453784 is a Phase 1 trial in healthy volunteers to evaluate pharmacokinetics and palatability of a minitablet formulation.
Yes, Obefazimod 50 mg Capsule is a formulation of Obefazimod. The drug is being developed in capsule and minitablet formulations for clinical use.