Abivax Sa · EURONEXT:ABVX
Abivax Sa — UEG Week Virtual 2021
16 slides from Abivax Sa's conference presentation, Oct 4, 2021
Slide 1: UEG Week Virtual 2021
UEG Week Virtual 2021 Oral ABX464 QD is efficacious and safe during phase 2b induction and maintenance treatment of ulcerative colitis patients Presented by: Prof. Séverine Vermeire, M.D., Ph.D. Head of the IBD Center at the University Hospitals Leuven, Belgium Abivax late-breaking abstract authors:
Slide 2: Disclosure of potential conflicts of interests
Disclosure of potential conflicts of interests Financial support for research: AbbVie, Takeda, Pfizer, Johnson & Johnson Lecture fee(s): Merck Sharp & Dohme Corp., AbbVie, Takeda, Ferring, Centocor, Hospira, Pfizer, Johnson & Johnson, Genentech/Roche, Tillotts; Consultancy: Merck Sharp & Dohme Corp.
Slide 3: Introduction
Introduction ➢ There is still a big need for alternative treatment options to treat patients with UC ➢ ABX464 is a first-in-class Small molecule, administered as once-daily oral capsule ➢ Novel mechanism of action: Selective upregulation of anti-inflammatory microRNA, miR-1241 ➢ Good safety profile
Slide 4: Aim and study design
Aim and study design A randomized, double-blind, placebo-controlled phase 2b induction study in patients with moderate to severe UC was conducted to evaluate the efficacy and safety of 3 daily doses of ABX464 (25, 50 and 100mg), followed by an open label maintenance (50mg QD). Modulating the immune
Slide 5: Study design
Study design: ABX464 phase 2b clinical study in patients with moderate-to-severe ulcerative colitis • 254 patients in 15 countries in Europe, US and Canada (130 study sites) • Moderate-to-severe active UC (Modified Mayo Score 5-9) • Central reading of endoscopies Randomization 1:1:1:1 Modulating the
Slide 6: Primary and secondary endpoints
Primary and secondary endpoints Primary endpoint Reduction from baseline in Modified Mayo Score at week 8 Key secondary endpoints 1. Number and rate of patients in clinical remission (stool frequency subscore (SFS) ≤1, rectal bleeding subscore (RBS) of 0 and endoscopic subscore ≤1) 2. Number and rat
Slide 7: Phase 2b: Baseline characteristics
Phase 2b: Baseline characteristics 100mg 50mg 25 mg Placebo (N=64) (N=63) (N=61) (N=64) Age (years) Mean (SD) 42.2 (12.34) 40.2 (13.94) 41.5 (14.16) 41.1 (14.43) Male n (%) 41 (64.1) 27 (42.9) 40 (65.6) 40 (62.5) Modified Mayo Score (MMS) Mean (SD) 7.0 (1.07) 7.1 (0.96) 7.1 (1.09) 7.0 (1.20) 7 to 9
Slide 8: Primary endpoint: Mean change from baseline in Modified Mayo Score
Primary endpoint: Mean change from baseline in Modified Mayo Score All patients (n=252) Biologics refractory patients (n=123) Placebo 25mg** 50mg** 100mg* Placebo 25mg** 50mg** 100mg** 0 0 -1 -1 -1 -2 -2 -1.9 -3 -3 -2.8 -2.8 -2.9 -2.9 -3.1 -3.2 -4 -4 *p-values of <0.01 versus placebo (ANCOVA) **p-va
Slide 9: Phase 2b top-line week 8 efficacy results (ITT): Secondary endpoints
Phase 2b top-line week 8 efficacy results (ITT): Secondary endpoints Clincal Remission Clincal Remission (Week 8 | ITT; All patients) (Week 8 | ITT; Bio refractory) 30% 30% 25% 28% 25% 25% 20% 20% 20% 19% 15% 15% 18% 10% 13% 10% 5% 5% 7% 3% 0% 0% Placebo 25mg* 50mg 100mg Placebo 25mg* 50mg 100mg* (n
Slide 10: Phase 2b top-line week 8 efficacy results (ITT): Secondary endpoints
Phase 2b top-line week 8 efficacy results (ITT): Secondary endpoints Clincal Response Endoscopic improvement (Week 8 | ITT; All patients) (Week 8 | ITT; All patients) 100% 50% 90% 45% 40% 44% 80% 40% 70% 35% 35% 60% 30% 67% 60% 25% 50% 55% 40% 20% 30% 15% 36% 10% 14% 20% 10% 5% 0% 0% Placebo 25mg* 5
Slide 11: Secondary endpoints: Fecal calprotectin and Robarts Histopathology Index
Secondary endpoints: Fecal calprotectin and Robarts Histopathology Index Mean Change from baseline in Fecal calprotectin (µg/g) Change from baseline in Robarts Histopathology Index 0 0 -1 -500 -2 -3 -1000 -1027.7 -3.40 -4 -1500 -5 -6 -2000 -5.90 -7 -2192.8 -7.30 -7.30 -2500 -2316.8 -2280.9 -8 Placeb
Slide 12: Phase 2b efficacy results (ITT): Onset of action
Phase 2b efficacy results (ITT): Onset of action Change from Baseline pMMS (least square mean) 0 -0.4 -0.7 -0.9 -0.8 P<0.001 -1,6 ------ Placebo P<0.001 -1.8 ------ 100mg -2.2 ------- 50mg -2.3 ------- 25mg Modulating the immune system to fight inflammatory and viral diseases, as well as cancer 12
Slide 13: ABX464 phase 2b maintenance study
ABX464 phase 2b maintenance study 217/222 eligible patients enrolled into maintenance The first 101 patients* of the 217 were to complete 1st year of maintenance by 15/09/21: (12 patients were drop-outs, and no data available for 1 patient at W48, these 13 patients were considered treatment failures
Slide 14: Safety data from 16-week induction study
Safety data from 16-week induction study Most common (> 5%) Adverse Events (AE): Drug-related or non-drug-related Placebo ABX464 25mg ABX464 50mg ABX464 100mg (N=64) (N=63) (N=63) (N=64) System Organ Class Adverse effect n (%) of pts with AE n (%) of pts with AE n (%) of pts with AE n (%) of pts wit
Slide 15: Summary
Summary ➢ In this Phase 2b induction study with ABX464, the primary endpoint (reduction of Modified Mayo Score ) was met with once-daily ABX464 (25mg, 50mg, 100mg) at week 8 ➢ Key secondary endpoints, including endoscopic improvement, clinical response and remission, and reduction in fecal calprotec
Slide 16: Abivax Industry Symposium at UEG Week Virtual 2021
Abivax Industry Symposium at UEG Week Virtual 2021 Program Prof. William Sandborn, M.D. San Diego, CA, USA The continued need to develop novel drugs for ulcerative colitis Didier Scherrer, Ph.D. Montpellier, France ABX464 novel mechanism of action: Upregulation of the anti-inflammatory microRNA miR-