Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Obefazimod
ABX196 · 3 trials · 3 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
Incidence and severity of adverse events evaluated according to CTC-AE
| 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 |
| Dose Escalation for ABX196 | EXPERIMENTAL | Dose escalation: ABX196 at 0.1, 0.2, or 0.4 µg i.m. was administered after completion of nivolumab infusion on Day 1 of every other 28-day treatment cycle (i.e., every 8 weeks). Nivolumab 240 mg i.v. was administered on Days 1 and 15 of each 28-day cycle. |
| 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 |
| ABX196 | DRUG | ABX196 is a synthetic agonist of invariant Natural Killer T (iNKT) cells |
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 ...
ABX196 is an investigational small molecule being studied for hepatocellular carcinoma, a form of liver cancer. It has been evaluated in a Phase 1 clinical trial in adults with this condition. It is not an approved therapy and remains in clinical development.
ABX196 targets invariant natural killer T cells, or iNKT cells. It is a small molecule designed to act on this immune cell population. This mechanism is being explored in the context of hepatocellular carcinoma.
ABX196 is being developed by Abivax SA, which trades under the ticker ABVX. The company is the sponsor of the clinical program for this asset.
ABX196 is in Phase 1 clinical development. The program has completed one Phase 1 trial. It is an investigational agent and has not been approved for any indication.
ABX196 has been studied in a Phase 1 trial, NCT03897543, titled ABX196 in Combination With Nivolumab in Patients With Hepatocellular Carcinoma. The trial was conducted in the United States, enrolled 10 patients, and is now completed.
No, ABX196 is not approved. It is an investigational small molecule in Phase 1 clinical development for hepatocellular carcinoma. The only recorded trial, NCT03897543, has completed, and the drug remains unapproved.