Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as ABX464 Single dose
ABX464 · 17 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
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.
number of incidences of all adverse events (AEs) (causally related and non-related) and SAEs, will be described further categorized by severity
number of incidences of treatment-emergent serious adverse events will be described
number of incidences of treatment-emergent adverse events of special interest (AESIs) will be described.
number of incidences of clinically significant laboratory abnormalities will be described
Peak Plasma Concentration (Cmax) for caffeine
Area under the plasma concentration versus time curve (AUC) for caffeine
Peak Plasma Concentration (Cmax) for ABX464
Area under the plasma concentration versus time curve (AUC) for ABX464
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. |
| 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) |
| 25 mg single dose | EXPERIMENTAL | Subject will receive a single oral dose of ABX464 25 mg or its matching placebo |
| 50 mg single dose | EXPERIMENTAL | Subject will receive a single oral dose of ABX464 50 mg or its matching placebo |
| 25 mg multiple dose | EXPERIMENTAL | Subject will receive a daily oral dose of ABX464 25 mg or its matching placebo for 28 days |
| 50 mg mulptiple dose | EXPERIMENTAL | Subject will receive a daily oral dose of ABX464 50 mg or its matching placebo for 28 days |
| Evaluation of CYP1A2 inhibition and induction potential by ABX464 | OTHER | Using a fixed-sequence crossover study design, the Pharmacokinetics (PK) of caffeine (50 milligrams (mg) single oral dose) will be evaluated in the absence and presence of ABX464 (50 mg once daily for 14 days) in 24 healthy subjects. Caffeine will be administered on Day 1 in the absence of ABX464, on Day 4 simultaneously with ABX464 to evaluate potential CYP1A2 inhibition by ABX464, and on Day 17 simultaneously with ABX464 following 14 days of once daily dosing of ABX464 to evaluate potential CYP1A2 induction by ABX464. |
| Evaluation of ABX464 as a substrate for CYP1A2 | OTHER | Using a fixed-sequence crossover study design, the PK of ABX464 (50 mg single oral dose) will be evaluated in the absence and presence of fluvoxamine (100 mg once daily for 10 days) in 36 healthy subjects. ABX464 will be administered on Day 1 in the absence of fluvoxamine and on Day 11 simultaneously with fluvoxamine following 10 days of once daily dosing of fluvoxamine to evaluate whether ABX464 is a substrate for CYP1A2 |
| 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 |
| Fasted Conditions | EXPERIMENTAL | 50mg of ABX464 (two 25mg capsules) /Fasted |
| Fed Conditions | EXPERIMENTAL | 50mg of ABX464 (two 25mg capsules) /Fed |
| Name | Type | Description |
|---|---|---|
| ABX464 | DRUG | Administered once daily in the morning with food |
| Placebo | DRUG | Administered once daily in the morning with food |
| 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 |
| Caffeine | DRUG | This is a 2 part, fixed-sequence open-label, crossover study to evaluate the potential CYP1A2-mediated drug-drug interactions (DDI), safety, and tolerability of ABX464 combined with a known CYP1A2 substrate (caffeine) |
| Fluvoxamine | DRUG | his is a 2 part, fixed-sequence open-label, crossover study to evaluate the potential CYP1A2-mediated drug-drug interactions (DDI), safety, and tolerability of ABX464 combined with a known CYP1A2 inhibitor (fluvoxamine). |
| ABX464 150mg | DRUG | ABX464 given orally at 150 mg per day from Day 0 to Day 28 (Cohort 1/ HIV infected subjects) |
| ABX464 Single dose | DRUG | Two-periods, subjects received a single dose of 50mg of ABX464 in fed and fasted condition, separated by a wash-out period of at least 45 days. |
| ABX464 Repeated dose | DRUG | Subjects received 50mg of ABX464 every 3 days during 10 days in fasted or fed condition. |
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...
Top 15 of 17 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Sanofi SA Sponsored ADR | SNY | 8 | PHASE3 | Duvakitug, SAR442970, balinatunfib, SAR441566, Dupilumab |
| Johnson & Johnson | JNJ | 13 | PHASE3 | Ustekinumab, Guselkumab, Golimumab, Infliximab, Icotrokinra |
| Eli Lilly and Company | LLY | 8 | PHASE3 | Mirikizumab, Tirzepatide, MORF-057, LY4395089, Eltrekibart |
| Takeda Pharmaceutical Co. Ltd. Sponsored ADR | TAK | 10 | PHASE3 | Vedolizumab, Zasocitinib |
| AbbVie, Inc. | ABBV | 14 | PHASE3 | Upadacitinib, Risankizumab, Lutikizumab, Adalimumab |
| Merck & Co., Inc. | MRK | 3 | PHASE3 | Tulisokibart, MK-8690 |
| Pfizer Inc. | PFE | 8 | PHASE3 | Etrasimod, tofacitinib |
| Gilead Sciences, Inc. | GILD | 3 | PHASE3 | Filgotinib, Tilpisertib Fosmecarbil, emvistegrast |
| Abivax SA Sponsored ADR | ABVX | 2 | PHASE3 | ABX464 |
| Bristol-Myers Squibb Company | BMY | 5 | PHASE2 | Ozanimod |
| Spyre Therapeutics, Inc | SYRE | 1 | PHASE2 | SPY001, SPY002, SPY003 |
| AnaptysBio, Inc. | ANAB | 1 | PHASE2 | Rosnilimab |
| Palatin Technologies, Inc. | PTN | 1 | PHASE2 | PL8177 |
| GSK plc Sponsored ADR | GSK | 1 | PHASE1 | GSK4528287 |
| Xencor, Inc. | XNCR | 1 | PHASE1 | XmAb942 |
ABX464 is an investigational small molecule being studied for the treatment of ulcerative colitis, rheumatoid arthritis, and HIV infection. It is also evaluated in healthy volunteers. The most advanced clinical program focuses on moderate to severe active ulcerative colitis, where the drug is in Phase 3 development.
ABX464 targets the CBC protein, also known as the cap-binding complex. By binding to this target, ABX464 modulates RNA processing and is thought to have anti-inflammatory and antiviral effects. This mechanism underlies its investigation in ulcerative colitis, rheumatoid arthritis, and HIV.
ABX464 is being developed by Abivax SA, a clinical-stage biotechnology company. Abivax trades on the Nasdaq Global Market under the ticker symbol ABVX. The company is advancing ABX464 through clinical trials for ulcerative colitis and other indications.
ABX464 is in Phase 2 clinical development overall, but it has also been evaluated in Phase 3 trials for ulcerative colitis. The Phase 3 ABTECT program includes the ABTECT-1 and ABTECT-2 induction trials and the ABTECT Maintenance trial. ABX464 is investigational and has not been approved by the FDA.
ABX464 has been studied in eight clinical trials, including Phase 3 trials NCT05507203 (ABTECT-1), NCT05507216 (ABTECT-2), and NCT05535946 (ABTECT Maintenance) in ulcerative colitis. A Phase 2 long-term safety and efficacy trial, NCT05177835, is also ongoing in ulcerative colitis. Two trials are currently active.