- |||||||||| Review, Journal: Drug Development in Inflammatory Bowel Diseases: What Is Next? (Pubmed Central) - Feb 26, 2025
Ongoing research into long-term safety and the development of personalized treatment strategies remains pivotal to enhance outcomes. Patient stratification and the strategic positioning of these therapies within the expanding treatment landscape are critical for optimizing their clinical impact.
- |||||||||| Undisclosed HBV therapeutic / Shanghai Jinwei Biotechnology, TheraVectys, HeberNasvac (ABX203) / Center for Genetic Engineering and Biotechnology, Abivax
Review, Journal: HeberNasvac: Development and Application in the Context of Chronic Hepatitis B. (Pubmed Central) - Jan 13, 2025 Aguilar JC, Akbar SMF, Al-Mahtab M, et al. HeberNasvac: Development and Application in the Context of Chronic Hepatitis B. Euroasian J Hepato-Gastroenterol 2024;14(2):221-237.
- |||||||||| obefazimod (ABX464) / Abivax
Integrated summary of safety of obefazimod for patients with moderately to severely active ulcerative colitis (Poster exhibition) - Dec 21, 2024 - Abstract #ECCOIBD2025ECCO_IBD_1076; P2, P2a, P Conclusion This integrated safety analysis of the 4 completed studies in the obefazimod UC clinical program indicates that exposure-adjusted incidence rates of TEAEs were generally numerically lower among patients treated with obefazimod relative to placebo. Integrated safety data further support a favorable safety and tolerability profile.
- |||||||||| obefazimod (ABX464) / Abivax
How Does It Work? (Helsinki 2) - Dec 21, 2024 - Abstract #ECCOIBD2025ECCO_IBD_290; These data further support the long-term efficacy and safety of a lower obefazimod maintenance dose. Sponsored by Abivax
- |||||||||| obefazimod (ABX464) / Abivax
Preclinical, Journal: Screening novel antiviral compounds to treat Clostridioides difficile infections. (Pubmed Central) - Dec 13, 2024 These include rottlerin (MIC50 = 0.25 ?g/mL), ?-mangostin (MIC50 = 1 ?g/mL), dryocrassin ABBA (MIC50 = 1 ?g/mL), and obefazimod (MIC50 = 4 ?g/mL)...All other drugs exhibited bacteriostatic activity. Given their characteristics, these compounds show great promise as novel treatments for CDI.
- |||||||||| Review, Journal: Current status of the small molecule anti-HIV drugs in the pipeline or recently approved. (Pubmed Central) - Aug 22, 2024
There is a considerable progress in the development of new anti-HIV drugs and the effort will continue since HIV infections has no cure or vaccine till now. Efforts are needed to reduce the toxicity of available drugs or discover new drugs with new classes which can delay the development of resistance.
- |||||||||| obefazimod (ABX464) / Abivax
Trial primary completion date: ABX464-107: ABTECT - Maintenance (clinicaltrials.gov) - Aug 7, 2024 P3, N=1050, Recruiting, Efforts are needed to reduce the toxicity of available drugs or discover new drugs with new classes which can delay the development of resistance. Trial primary completion date: Dec 2029 --> Jan 2026
- |||||||||| obefazimod (ABX464) / Abivax
Trial completion date, Trial primary completion date: ABX464-107: ABTECT - Maintenance (clinicaltrials.gov) - Aug 1, 2024 P3, N=1050, Recruiting, Trial primary completion date: Dec 2029 --> Jan 2026 Trial completion date: Jun 2026 --> Jan 2030 | Trial primary completion date: Jan 2026 --> Dec 2029
- |||||||||| obefazimod (ABX464) / Abivax
Phase classification, Enrollment change, Trial withdrawal: Phase 2b/3 Study of ABX464 in Moderate to Severe Active Crohn's Disease Patients (clinicaltrials.gov) - Jul 31, 2024 P2/3, N=0, Withdrawn, Trial completion date: Jun 2026 --> Jan 2030 | Trial primary completion date: Jan 2026 --> Dec 2029 Phase classification: P2a --> P2/3 | N=30 --> 0 | Unknown status --> Withdrawn
- |||||||||| obefazimod (ABX464) / Abivax
Trial completion date, Trial primary completion date: ABX464-107: ABTECT - Maintenance (clinicaltrials.gov) - Jun 24, 2024 P3, N=1050, Recruiting, The safety profile remains consistent over time, regardless of treatment response at week 8. Trial completion date: Jun 2025 --> Jun 2026 | Trial primary completion date: Apr 2025 --> Jan 2026
- |||||||||| obefazimod (ABX464) / Abivax
Trial completion date, Trial primary completion date: ABX464-105: ABTECT-1 - ABX464 Treatment Evaluation for Ulcerative Colitis Therapy -1 (clinicaltrials.gov) - May 20, 2024 P3, N=612, Recruiting, Trial completion date: Jun 2024 --> Feb 2025 | Trial primary completion date: May 2024 --> Dec 2024 Trial completion date: Jun 2024 --> Feb 2025 | Trial primary completion date: May 2024 --> Dec 2024
- |||||||||| obefazimod (ABX464) / Abivax
11025: Product Theater: An Investigational New MOA that Can Stabilize the Inflammatory Response in Ulcerative Colitis (DDW Theater 1 - Walter E. Washington Convention Center) - Apr 18, 2024 - Abstract #DDW2024DDW_8494; Obefazimod is an investigational, oral, once-daily, small molecule in phase 3 clinical trials for ulcerative colitis (UC). Obefazimod is the first and only molecule that enhances the expression of microRNA-124, a natural regulator of the inflammatory response, returning cytokines and immune cells to homeostatic levels, potentially helping to stabilize the inflammatory response and modify the progression of diseases like UC.
- |||||||||| obefazimod (ABX464) / Abivax
Journal: Structure-activity relationship and target investigation of 2-aryl quinolines with nematocidal activity. (Pubmed Central) - Apr 8, 2024 Within the context of our anthelmintic discovery program, we recently identified and evaluated a quinoline derivative, called ABX464 or obefazimod, as a nematocidal candidate; synthesised a series of analogues which were assessed for activity against the free-living nematode Caenorhabditis elegans; and predicted compound-target relationships by thermal proteome profiling (TPP) and in silico docking...Future work aims to optimise this compound as a nematocidal candidate and investigate its pharmacokinetic properties. Overall, this study presents a first step toward the development of a new nematocide.
- |||||||||| 5115: IBD Controlled Trials II (Ballroom B - Walter E. Washington Convention Center) - Mar 14, 2024 - Abstract #DDW2024DDW_6503;
MH002, risankizumab, and mirikizumab will be presented. Learning Objectives: Describe safety of oral sphongosine-1-phosphate receptor modulators, Determine safety and efficacy of MH002 and describe its mechanism of action, Describe safety and efficacy of interleukin-23 antagonosists
- |||||||||| obefazimod (ABX464) / Abivax
EFFICACY OF ONCE-DAILY, ORALLY ADMINISTERED OBEFAZIMOD IN PATIENTS WITH MODERATELY TO SEVERELY ACTIVE UC AT WEEKS 8, 48, AND 96 BROKEN DOWN BY INDUCTION TREATMENT DOSE (Hall A, Poster Hall - Walter E. Washington Convention Center) - Mar 14, 2024 - Abstract #DDW2024DDW_3237; After switching to 50 mg in the OLM, the rate of clinical remission increased to 60% (35/58) at both weeks 48 and 96. Similar trends were observed for clinical response (66% (38/58) at week 8, 85% (49/58) at week 48, and 74% (43/58) at week 96) , endoscopic improvement (36% (21/58) at week 8, 60% (35/58) at week 48, and 66% (38/58) at week 96), and endoscopic remission (7% (4/58) at week 8, 28% (16/58) at week 48, and 47% (27/58) at week 96).
- |||||||||| obefazimod (ABX464) / Abivax
Journal: Structure activity relationship and target prediction for ABX464 analogues in Caenorhabditis elegans. (Pubmed Central) - Jan 17, 2024 Taken together, the findings from this study contribute significantly to the early-stage drug discovery of a new nematocide based on ABX464. Future work is aimed at validating the ABX464-protein interactions identified here, and at assessing ABX464 and associated analogues against a panel of parasitic nematodes, towards developing a new anthelmintic with a mechanism of action that is distinct from any of the compounds currently-available commercially.
- |||||||||| HeberNasvac (ABX203) / Center for Genetic Engineering and Biotechnology, Abivax
Journal, IO biomarker: Preparing for the Next Pandemic: Increased Expression of Interferon-Stimulated Genes After Local Administration of Nasalferon or HeberNasvac. (Pubmed Central) - Dec 20, 2023 In most cases, the gene expression induced by HeberNasvac was similar in profile and intensity to the expression induced by Nasalferon and significantly superior to that observed in untreated controls. The immune stimulatory effect of HeberNasvac on ISGs paved the way for its future use as an innate immunity stimulator in elderly persons and immunocompromised subjects or as part of Mambisa, a nasal vaccine to prevent severe acute respiratory syndrome coronavirus 2 infection.
- |||||||||| obefazimod (ABX464) / Abivax
Enrollment closed, Trial completion date, Trial primary completion date: Long-term Safety and Efficacy Profile of ABX464 in Subjects With Moderate to Severe Active Ulcerative Colitis (clinicaltrials.gov) - Dec 18, 2023 P2, N=203, Active, not recruiting, The immune stimulatory effect of HeberNasvac on ISGs paved the way for its future use as an innate immunity stimulator in elderly persons and immunocompromised subjects or as part of Mambisa, a nasal vaccine to prevent severe acute respiratory syndrome coronavirus 2 infection. Recruiting --> Active, not recruiting | Trial completion date: Apr 2026 --> Apr 2027 | Trial primary completion date: Feb 2023 --> Feb 2027
- |||||||||| miravirsen (SPC3649) / BMS, cobomarsen (MRG-106) / Viridian Therap, obefazimod (ABX464) / Abivax
Review, Journal: MicroRNA-based therapeutics for inflammatory disorders of the microbiota-gut-brain axis. (Pubmed Central) - Aug 21, 2023 With increasing evidence of the pathophysiological importance for miRNAs in microbiota-gut-brain axis disorders, therapeutic targeting of cross-regulated miRNAs in these disorders displays potentially transformative and translational potential. Further preclinical research and human clinical trials are required to further advance this area of research.
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