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LONG-TERM UPREGULATION OF MIR-124 IN BLOOD AND RECTAL BIOPSIES OF PATIENTS WITH MODERATE-TO-SEVERE ULCERATIVE COLITIS RECEIVING OBEFAZIMOD 50 MG DAILY FOR 96-WEEKS

Julien Santo 1, Aurélien Flatres 1, Paul GINESTE 2, Didier scherrer 1, Josianne Nitcheu 2, Sheldon Sloan 2, Hartmut Ehrlich 2, Bruce E. Sands 3, Severine Vermeire 4

Affiliations

1 Abivax, Montpellier, France

2 Abivax, Paris, France

3 Icahn School of Medicine at Mount Sinai, New York, United States

4 University Hospitals Leuven, Leuven, Belgium

Summary

AI Generated

Long-term treatment with obefazimod 50 mg once daily in moderate-to-severe ulcerative colitis patients maintained significant upregulation of anti-inflammatory microRNA miR-124 in blood and rectal tissue over 96 weeks.

Obefazimod 50 mg once daily significantly upregulated miR-124 in both blood and rectal tissue at weeks 48 and 96 compared to baseline (p<0.001).
The miR-124 upregulation was observed in all patients during the 96-week maintenance phase, including those who received placebo during the initial 16-week induction phase.
In rectal tissue, median fold changes from baseline ranged from 4.5 to 10.3 across treatment groups at weeks 48 and 96, while blood showed larger increases ranging from 128.2 to 396.8.
The study used droplet digital PCR technology to quantify miR-124 copy number in 115 whole blood samples and 508 rectal biopsy samples collected at baseline, week 48, and week 96.
This material is relevant for researchers and clinicians interested in the mechanism of action and long-term molecular effects of obefazimod in ulcerative colitis.

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This summary was generated by an AI large language model based on the content transcript. It is for informational purposes only and should not be considered a substitute for clinical judgment. Always rely on your professional expertise and the full clinical context when making clinical decisions.

Abstract

Introduction

Obefazimod is an oral small molecule that has demonstrated long-term efficacy and safety in patients with moderate-to-severe ulcerative colitis (UC) (1,2). Obefazimod is known to modulate inflammation by upregulating a specific anti-inflammatory micro-RNA (miR-124) (3). We examined the long-term effects of obefazimod on miR-124 in blood and rectal biopsies of patients enrolled in a 96-week maintenance study.

Aims & Methods

Patients received placebo or obefazimod 25mg, 50mg or 100mg once daily (od) during a 16-week induction phase and, irrespective of their clinical response, could enter an open-label 96-week maintenance phase with obefazimod 50mg od. Absolute quantification (QuantaSoft Pro) of the miR-124 copy number was performed at baseline, weeks 48 and 96 by using droplet digital PCR technology on 115 whole blood samples and 508 rectal biopsy samples. An ANOVA was performed including treatment, time, the interaction between treatment and time, the baseline value as fixed factor and time as repeated effect.

Results

A daily treatment with obefazimod 50 mg significantly upregulated miR-124 over time in blood and rectal tissue at weeks 48 and 96 (p<0.001 vs. baseline). The miR-124 upregulation was observed in all patients, including those previously receiving placebo during the induction phase.

Table: Upregulated miR-124 in rectal tissue and blood of patients receiving obefazimod 50 mg during the maintenance phase

Treatment during the induction phase	Time	Rectal tissue Median fold change from baseline	Blood Median fold change from baseline
Obefazimod 100 mg	W48	4.8 ^†	128.2 ^†
Obefazimod 100 mg	W96	7.4 ^†	188.3 ^†
Obefazimod 50 mg	W48	5.8 ^†	230.1 ^†
Obefazimod 50 mg	W96	10.3 ^†	244.4 ^†
Obefazimod 25 mg	W48	4.5 ^†	308.8 ^†
Obefazimod 25 mg	W96	8.5 ^†	128.5 ^†
Placebo	W48	4.8 ^†	237.0 ^†
Placebo	W96	7.5 ^†	396.8 ^†

†: p<0.001 vs. baseline ; each timepoint (W48 and W96) is compared to the baseline using a Dunnett adjustment.

Conclusion

The 96-week efficacy of obefazimod 50mg od in patients with moderate-to-severe UC is associated with a maintained increase in miR-124 expression in blood and rectal tissue.

References

Vermeire S, Sands B, Tilg H et al. ABX464 (obefazimod) for moderate-to-severe, active ulcerative Colitis: a phase 2b, double-blind, randomised, placebo-controlled induction trial and 48 week, open-label extension. Lancet Gastroenterol Hepatol 2022, 7 (11): 1024-1035
Vermeire S, Sands B, Biguenet S et al. ABX464 (obefazimod) in patients with moderate-to-severe ulcerative colitis: an Interim 48-week the safety and efficacy analysis from an ongoing 96-week open-label maintenance phase 2b study. UEG journal 2022, 10 (S8): p.340
Apolit C, Campos N, Vautrin A et al. ABX464 (obefazimod) up-regulates miR-124 to reduce pro-inflammatory markers in inflammatory bowel diseases. Clin Trans Gastroenterol; 14(4):p e00560, April 2023; DOI: 10.14309/ctg.0000000000000560

Disclosure

Bruce E Sands reports consulting fees from Abbvie, Alimentiv , Amgen, Arena Pharmaceuticals, Artugen Therapeutics, Astra Zeneca, Boehringer Ingelheim, Boston Pharmaceuticals, Calibr, Celgene, Celltrion, ClostraBio, Equillium, Enthera, Evommune, Fresenius Kabi, Galapagos, Genentech (Roche), Gilead Sciences, GlaxoSmithKline, Gossamer Bio, Index Pharmaceuticals, Innovation Pharmaceuticals, Inotrem, Kaleido, Kallyope, Merck, Morphic Therapeutics, MRM Health, Progenity, Prometheus Biosciences, Prometheus Laboratories, Protagonist Therapeutics, Q32 Bio, Sun Pharma, Surrozen, Target RWE,Teva, TLL Pharmaceutical, Ventyx Biosciences; consulting and speaking fees from Abivax; consulting and speaking fees and other support from Lilly; research grants, consulting and speaking fees and other support from Bristol Myers Squibb, Janssen, Pfizer, Takeda; research grants and consulting fees from Theravance Biopharma; and stock options from Ventyx Biopharma.
Séverine Vermeire has received grants from AbbVie, J&J, Pfizer, Takeda and Galapagos; Séverine Vermeire has received consulting and/or speaking fees from: AbbVie, Abivax, AbolerIS Pharma, AgomAb, Alimentiv, Arena Pharmaceuticals, AstraZeneca, Avaxia, BMS, Boehringer Ingelheim, Celgene, CVasThera, Cytoki Pharma, Dr Falk Pharma, Ferring, Galapagos, Genentech-Roche, Gilead, GSK, Hospira, Imidomics, Janssen, J&J, Lilly, Materia Prima, MiroBio, Morphic, MrMHealth, Mundipharma, MSD, Pfizer, Prodigest, Progenity,

Conference

UEG Week Copenhagen 2023

Topics

IBD

Submission format

Abstract

Session

PP 05 IBD (Posters)

Citation

United European Gastroenterology Journal 2023; 11 (Supplement 8)

Published

2023

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NDR quintile	NDR range (%)	NDR (95CI) (%)	ADR (95CI) (%)
20–40%	3.7–5.6	4.9 (2.8–8.3)	39.7 (33.8–45.9)
40–60%	6.0–9.4	8.3 (6.1–11.2)	57.5 (52.9–62.0)
60–80%	10.1–11.3	10.8 (7.3–15.9)	59.1 (52.2–65.6)
80–100%	13.0–21.8	15.8 (13.0–19.1)	67.0 (63.0–70.7)

Baseline Characteristics	N=67	%
Age, median	40
Female	33	49
UC	48	72
5mg/kg 8WE	17	25
7.5mg/kg	17	25
10mg/kg	29	43
Baseline CRP, median (mg/L)	1
Baseline FCP, median (mg/g)	38
Baseline IUS SAS, median	8.4