Abivax Sa · EURONEXT:ABVX
Abivax Sa — 40th Annual J.P. Morgan Healthcare Conference 2022
20 slides from Abivax Sa's conference presentation, Jan 13, 2022
Slide 1: ABX464 – A future game changer for the treatment of chronic inflammatory diseases
ABX464 – A future game changer for the treatment of chronic inflammatory diseases Abivax, a late-stage clinical biotech company 40th Annual J.P. Morgan Healthcare Conference January 10-14, 2022 Prof. Hartmut J. Ehrlich, M.D., CEO
Slide 2: Disclaimer
Disclaimer This presentation contains information pertaining to Abivax S.A. (“Abivax” or the “Company”). Neither Abivax, nor its management, shareholders, directors, advisors, employees or representatives make any representation or warranty, express or implied, as to the fairness, the accuracy, comp
Slide 3: Abivax and ABX464 for chronic inflammatory diseases: Main take-home messages
Abivax and ABX464 for chronic inflammatory diseases: Main take-home messages ABX464 is a potent anti-inflammatory oral drug candidate with a novel first-in-class mechanism of 1 action: Upregulation of the physiological anti-inflammatory microRNA, miR-124 Safety and efficacy demonstrated in phase 2a
Slide 4: ABX464 novel mechanism of action: upregulation of miR-124
ABX464 novel mechanism of action: Potent and specific upregulation of miR-124, activating a “physiological brake” by reducing the expression of inflammatory cytokines and cells to normal levels • First-in-class mechanism of action related to intracellular upregulation of miR-124. • microRNAs work by
Slide 5: Significant miR-124 upregulation detected in rectal biopsies and blood
Significant miR-124 upregulation detected in rectal biopsies and blood (phase 2b UC study) Dose relationship observed in rectal tissue and whole blood miR-124 blood levels miR-124 in rectal tissue Baseline D1 D8 D57 D57 week 8 (d56) ✱✱✱✱ ✱✱✱✱ ns ✱✱✱✱ ✱✱✱✱ ✱✱✱✱ 100000 ns 100000 ✱✱✱✱ 100000 ✱✱✱ ✱✱✱✱ n
Slide 6: Positive phase 2a study led to the conduct of a large-scale phase 2b study
Positive phase 2a study led to the conduct of a large-scale phase 2b study of ABX464 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, independent and bl
Slide 7: Week 8 Efficacy Results (ITT): Primary Endpoint met
Week 8 Efficacy Results (ITT): Primary Endpoint met - Efficacy confirmed for all patients and also for subset of bio-refractory patients Week 8 Results Placebo 25mg 50mg 100mg (ITT1 population / n=252) Primary Endpoint All -1.9 -3.1 ** -3.2 ** -2.9 * Modified Mayo Score patients Mean change from bas
Slide 8: Week 8 Efficacy Results (ITT): Secondary endpoints
Week 8 Efficacy Results (ITT): Secondary endpoints - Efficacy confirmed for all patients and also for subset of bio-refractory patients Week 8 Results Placebo 25mg 50mg 100mg (ITT population / n=252) Key Secondary Endpoints (not powered for statistical significance) All patients 8 (13.6%) 20 (34.5%)
Slide 9: Week 4 and Week 8 Efficacy Results (ITT): Fast onset of action
Week 4 and Week 8 Efficacy Results (ITT): Fast onset of action Change from Baseline pMMS (least square mean) 0 -0.4 -0.7 -0.9 -0.8 P<0.001 Placebo -1,6 P<0.001 -1.8 100mg 50mg -2.2 -2.3 25mg Modulating the immune system to fight inflammatory and viral diseases, as well as cancer 9
Slide 10: ABX464 phase 2b maintenance study – impressive one-year efficacy confirmed
ABX464 phase 2b maintenance study – impressive one-year efficacy confirmed Phase 2b study: 217/222 eligible patients enrolled into maintenance The first 101 patients of the 217 were to complete 1st year of maintenance by Sept. 15, 2021: (12 patients were drop-outs, and no data available for 1 patien
Slide 11: ABX464 phase 2a maintenance study – long-term efficacy (3 years) confirmed
ABX464 phase 2a maintenance study – impressive long-term efficacy (3 years) confirmed Phase 2a study 2 1st year 2nd year 3rd year Clinical remission (ITT) 12/22 (54.5%) 11/22 (50.0%) 11/22 (50.0%) 2 Irrespective of patient outcome at the end of the induction phase Modulating the immune system to fig
Slide 12: ABX464 well positioned in the competitive landscape for induction and maintenance
ABX464 well positioned in the competitive landscape for both induction and maintenance - Clinical Remission Rates Drug Study Active Placebo Delta Active Placebo Delta Results of Maintenance studies (ITT)* Results of Induction studies (ITT)* (Patients with clinical response at the end of the inductio
Slide 13: Complete resolution of UC lesions in an ABX464 treated patient
Complete resolution of UC lesions in an ABX464 treated patient (vedolizumab, infliximab and adalimumab resistant) during 3 years of open-label maintenance treatment Endoscopy before Endoscopy after Endoscopy after Endoscopy after ABX464 1st year of ABX464 2nd year of ABX464 3rd year of ABX464 ➢ 52-y
Slide 14: Favorable ABX464 safety profile
Favorable ABX464 safety profile Safety in phase 2b study in UC patients confirms profile observed in the phase 2a study ➢ No new safety signal, no death, no malignancy ➢ Most frequently reported AEs are headaches (20% for 25mg and 8% for placebo), which occur early (first 10 days of treatment) and a
Slide 15: Favorable ABX464 safety profile across all clinical studies
Favorable ABX464 safety profile across all clinical studies • More than 1,000 subjects exposed to ABX464 (Cut-off date Nov. 30, 2021) → Total subjects exposed: 1,069 → Subjects exposed at 25mg: 143 → Subjects exposed at 50mg: 750 → Subjects exposed at 100mg: 95 • ABX464 also showed good safety profi
Slide 16: How to bring ABX464 to the market in ulcerative colitis
How to bring ABX464 to the market in ulcerative colitis Ulcerative colitis phase 3 preparation on track • FDA end of phase 2 meeting feedback and EMA scientific advice with guidance and a path forward • Abivax intends to study 25mg and 50mg in the induction studies and possibly one lower dose during
Slide 17: A potential mega-blockbuster in IBD
ABX464: A potential mega-blockbuster in IBD Size of target market increasing by 70% in UC and by nearly 20% in CD (2021 - 2027) 2021 Total market size1 In million cases in inflammatory UC Epidemiology Total Cases WW 13 diseases > USD 90B Total Cases G7 3.6 Market size1,2 ABX464 UC: USD 6.2B addresse
Slide 18: ABX464 is a potential drug in IBD and multiple chronic inflammatory diseases
ABX464 is a potential drug in IBD and multiple chronic inflammatory diseases Phase 2a clinical study in RA - Top-line results allowing to move into phase 2b 3-months induction study in 60 patients (placebo, 50mg and 100mg ABX464): Baseline characteristics well balanced across all groups Primary endp
Slide 19: ABX464 newsflow through Q2 2022
ABX464 newsflow through Q2 2022 Q4 2021 Q1 2022 Q2 2022 Top-line results Publication of full- UC - Phase 2b (ABX464) (One-year length phase 2b maintenance data) manuscript UC - Phase 3 (ABX464) FDA feedback ✓ EMA feedback ✓ FPI phase 3 study Top-line results Publication of full- RA - Phase 2a (ABX46
Slide 20: Thank you for your attention!
Thank you for your attention! Abivax SA 5, rue de la Baume 75008 Paris France T: +33 (0) 1 53 83 08 41 M: info@abivax.com Modulating the immune system to fight inflammatory and viral diseases, as well as cancer 20
Abivax — 40th Annual J.P. Morgan Healthcare Conference 2022 on 6ix