Approval Probability
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Also known as Obefazimod Minitablet, ABX464, ABX196
Obefazimod · 15 trials · 8 indications
To compare the efficacy of ABX464 versus placebo on clinical remission. Clinical remission is defined as stool frequency subscore (SFS) = 0 or 1 and rectal bleeding subscore (RBS) = 0, and Mayo Endoscopic Score (MES) = 0 or 1 (MES of 1 modified to exclude friability).
The Part 1 primary objective is to compare the efficacy of ABX464 versus placebo on the proportion of subjects in clinical remission \[SFS = 0 or 1, RBS = 0 and endoscopy sub-score = 0 or 1\] at Week 44.
The Part 2 primary objective is safety
The Part 2 primary objective is safety
The Part 2 primary objective is safety
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)
To evaluate the long-term safety of ABX464 given at 25 mg once daily in subjects with Moderate to Severe Active Ulcerative Colitis.
Clinical remission (based on the Mayo scoring system) is defined as: a rectal bleeding sub-score = 0, and an endoscopy sub-score ≤1 (excluding friability), and at least 1-point decrease in stool frequency sub-score from baseline to achieve a stool frequency sub-score ≤1
Incidence of adverse events emerging during the treatment
Reduction from baseline in Modified Mayo Score (MMS) MMS is a composite score of UC disease activity based on the following 3 subscores: 1. Stool frequency subscore (SFS), scored from 0 (normal number of stools) to 3 (5 or more stools more than normal). 2. Rectal bleeding subscore (RBS), scored from 0 (no blood seen) to 3 (blood alone passed). 3. Endoscopic subscore, scored from 0 (normal or inactive disease) to 3 (severe disease, spontaneous bleeding, ulceration). The overall MMS ranges from 0 to 9 where higher scores represent more severe disease.
TEAE definition is undesirable events not present prior to medical treatment, or an already present event that worsens either in intensity or frequency following the treatment
Number of treatment-emergent adverse events in ABX464 treated subjects
Number of treatment-emergent adverse events in the ABX464 treated subjects compared to placebo
Patients who had received at least one dose of the study drug, and who had at least one baseline value. An AE was classified as a TEAE if it started, or increased in severity, on or after the first date and time of medication dosing (from Day 1 up to Day 28). Any AE which occurred after Day 28 was classified as post-treatment-emergent. Events were graded according to the "Division of AIDS table for grading the severity of adult and pediatric adverse events" (Version 2.0 November 2014).
Number of patients with abnormal blood (hematology and biochemistry) and urinary laboratory values, abnormal vital signs and ECG parameters and the number/proportion of patients reporting any adverse event.
Incidence and severity of adverse events evaluated according to CTC-AE
Pharmacokinetic parameters
Pharmacokinetic parameters
Pharmacokinetics parameters
Pharmacokinetic parameters
Pharmacokinetic parameters
Pharmacokinetic parameters
Pharmacokinetic parameters
Pharmacokinetic parameters
Pharmacokinetic parameters
Pharmacokinetic parameters
| Arm | Type | Description |
|---|---|---|
| ABX464 50mg | EXPERIMENTAL | Subjects will be orally dosed daily in a fed condition (ideally at the same time in the morning) for 8 weeks |
| ABX464 25mg | EXPERIMENTAL | Subjects will be orally dosed daily in a fed condition (ideally at the same time in the morning) for 8 weeks |
| Placebo | PLACEBO_COMPARATOR | Subjects will be orally dosed daily in a fed condition (ideally at the same time in the morning) for 8 weeks |
| ABX464 50mg - Responder subjects at the end of induction | PLACEBO_COMPARATOR | Subjects will be orally dosed during 44 weeks |
| ABX464 25mg - Responder subjects at the end of induction | PLACEBO_COMPARATOR | Subjects will be orally dosed during 44 weeks |
| Placebo - Responder subjects at the end of induction | PLACEBO_COMPARATOR | Subjects will be orally dosed during 44 weeks |
| ABX464 50mg - Non responder subjects at the end of induction | EXPERIMENTAL | Subjects will be orally dosed during 44 weeks |
| ABX464 25mg - Non responder subjects at the end of induction | EXPERIMENTAL | Subjects will be orally dosed during 44 weeks |
| Long Term Extension | EXPERIMENTAL | At the end of the maintenance phase (week 44), subjects can continue their allocated treatment for up to 4 years. Once the maintenance phase is unblinded, subjects receiving placebo in the maintenance phase will be allocated to obefazimod 25 mg or can terminate the study. |
| 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) |
| ABX464 -25mg | EXPERIMENTAL | All subjects will receive ABX464 given at 25 mg QD. |
| ABX464 50 mg | EXPERIMENTAL | All subjects will receive ABX464 administered at 50 mg o.d for an overall period of 2 years (104 weeks) |
| ABX464 100 mg | EXPERIMENTAL | ABX464 100 mg was administered orally (capsules) once daily for 16 weeks |
| ABX464 25 mg | EXPERIMENTAL | ABX464 25 mg was administered orally (capsules) once daily for 16 weeks |
| Matching Placebo | PLACEBO_COMPARATOR | Matching placebo was administered orally (capsules) once daily for 16 weeks |
| ABX464 50mg + methotrexate | EXPERIMENTAL | Participants will receive one capsule of 50mg ABX464 plus one capsule of matching placebo once daily for 12 weeks \+ methotrexate |
| ABX464 100mg + methotrexate | EXPERIMENTAL | Participants will receive two capsules of 50mg ABX464 once daily for 12 weeks \+ methotrexate |
| Placebo + methotrexate | PLACEBO_COMPARATOR | Participants will receive two capsules of matching placebo once daily for 12 weeks \+ methotrexate |
| ABX464 Treatment arm | EXPERIMENTAL | All subjects will receive ABX464 at 50 mg o.d for an overall period of 48 months. |
| ABX464 matching placebo Treatment Arm | PLACEBO_COMPARATOR | Subjects will receive 50 mg of ABX464 matching Placebo orally once daily for 56 days. |
| ABX464 | EXPERIMENTAL | Fixed dose of ABX464 50mg once daily given during 28 days in association with darunavir + ritonavir (DRV/RTV) or darunavir + cobicistat (DRV/COBI) |
| ABX464 Matching placebo | PLACEBO_COMPARATOR | Matching placebo of ABX464 given at 50mg once daily in association with darunavir + ritonavir (DRV/RTV) or darunavir + cobicistat (DRV/COBI) |
| 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. |
| ABX464 150mg | EXPERIMENTAL | ABX464, 50mg per Capsule Three Capsules per day for 28 days |
| ABX464 50mg for 28 days | EXPERIMENTAL | ABX464, 50mg per Capsule One Capsule per day for 28 days |
| ABX464 50mg for 84 days | EXPERIMENTAL | ABX464, 50mg per Capsule One Capsule per day for 84 days |
| Name | Type | Description |
|---|---|---|
| ABX464 | DRUG | Administered once daily in the morning with food |
| Placebo | DRUG | Administered once daily in the morning with food |
| Obefazimod | DRUG | Obefazimod is administered once-daily in fed condition (ideally at the same time in the morning). |
| ABX464 100 mg | DRUG | ABX464 100 mg (two capsules of ABX464 50 mg) once daily for 16 weeks |
| ABX464 50 mg | DRUG | ABX464 50 mg (one capsule of ABX464 50 mg + one capsule of placebo) once daily for 16 weeks |
| ABX464 25 mg | DRUG | ABX464 25 mg (one capsule of ABX464 25 mg + one capsule of placebo) once daily for 16 weeks |
| ABX464 50mg | DRUG | ABX464 is a new anti-inflammatory drug |
| Matching Placebo | DRUG | placebo matching with ABX464 |
| ABX464 100mg | DRUG | ABX464 is a new anti-inflammatory drug |
| Methotrexate | DRUG | MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study |
| Placebo oral capsule | DRUG | Placebo matching with ABX464 |
| ABX196 | DRUG | ABX196 is a synthetic agonist of invariant Natural Killer T (iNKT) cells |
| ABX464 150mg | DRUG | ABX464 given orally at 150 mg per day from Day 0 to Day 28 (Cohort 1/ HIV infected subjects) |
Inclusion Criteria: * Men or women at least 16 years old; Adolescent subjects will only be enrolled if approved by the country regulatory/health authority. If these approvals have not been granted, only subjects ≥ 18 years old will be enrolled. To be eligible, adolescent subjects must weigh ≥ 40 kg...
Obefazimod is an investigational oral small molecule being studied for the treatment of moderately to severely active Crohn disease. It is not yet approved for any indication and remains in clinical development. Abivax SA is evaluating it in adults with this gastrointestinal condition.
Obefazimod targets NCBP2 and NCBP1, components of the nuclear cap-binding complex. It is classified as a modulator of these targets. By acting on NCBP2 and NCBP1, the drug is designed to influence RNA processing pathways relevant to inflammatory signaling in Crohn disease.
Obefazimod is being developed by Abivax SA, a biopharmaceutical company whose shares trade under the ticker ABVX. Abivax is the sponsor of the clinical program evaluating the drug in inflammatory bowel disease, including the ongoing Crohn disease study.
Obefazimod is in Phase 2 clinical development for moderately to severely active Crohn disease. It is an investigational therapy and has not been approved by the FDA or any other regulatory agency for this indication. The current Crohn disease trial is actively recruiting participants.
Obefazimod is being studied in the Phase 2 trial NCT06456593, titled Efficacy and Safety of Obefazimod in Subjects With Moderately to Severely Active Crohn's Disease. The trial is randomized, double-blind, and placebo-controlled, with an planned enrollment of 212 adults across the United States and several European countries.
Yes. Obefazimod is also referred to as obefazimod 50 mg capsule, obefazimod minitablet 50 mg, and obefazimod minitablet. These names describe the same active drug candidate developed by Abivax SA for moderately to severely active Crohn disease, and they refer to different oral formulation presentations of the compound.