Abivax Sa · EURONEXT:ABVX
Abivax Sa — DDW San Diego 2019
20 slides from Abivax Sa's conference presentation, May 21, 2019
Slide 1: ABX464 is safe and efficacious in a proof of concept study in Ulcerative Colitis patients
ABX464 is safe and efficacious in a proof of concept study in Ulcerative Colitis patients S. Vermeire, X. Hébuterne, P. Napora, M. Wisniewska-Jarosinska, G. Kiss, A. Bourreille, Z. Przemysław, J. Nitcheu, P. Gineste, J.-M. Steens, H. Ehrlich DDW San Diego May 21, 2019 1
Slide 2: Disclosures
Disclosures GSK shareholder ABIVAX employee and shareholder options 2
Slide 3: Background
Background Despite'the'availability'of'new'drugs,'there'is'still'a'high'unmet'medical'need'for' patients'suffering'from'Ulcerative'Colitis'and'Crohn’s'Disease ABX464 • Is+a+small+molecule+administered+as+an+oral+capsule • Has+antiretroviral+properties,+reduces+total+HIV=DNA+and+was+studied+in+more+t
Slide 4: ABX464 Proposed mechanism of action
ABX464/0 Proposed/mechanism/of/action NORMAL/CBC/FUNCTION ABX464/and/CBC/FUNCTION 1 1 CBC binds/to/the//majority/of/RNAs/ ABX464 ABX464 acts/on/the/CBC/to/increase/miR0 generated/ in/the/nucleus and/recruits CBC factors necessary/ for/its/processing CBC 124 carrying/RNA/binding 2 2 CBC+binds&weakly&
Slide 5: ABX464 showed efficacy in DSS Mice Model
B submucosa ABX464/showed/efficacy/in/DSS/Mice/Model A induction of inflammation * analysis DSS water days MC 0 1 2 3 4 5 6 7 8 9 10 11 gavage ABX464/protects/mice/from/death/in/the/DSS/mouse/model ABX464 DSS/without treatment leads/to/ ABX464/protects/ intestinal/damage intestinal/Structure 120 Ind
Slide 6: Study Design
Study/Design Randomized,+double/blind,+placebo+controlled,+multi/national+study Induction+Study (ABX464=101) Open+Label+Extension+(ABX464=102)+ 8+weeks of+treatment 52+weeks (Ongoing) ABX464+– Single+Dose+50mg+o.d. Randomisation+ ABX464+– Single+Dose+50mg+o.d. 2:1 Matching+Placebo • Study+Population
Slide 7: Recruitment Flow
Recruitment/Flow Screened+(N=+46) Randomized+(N=32) ABX464+(N=+23) Placebo+(N=+9) 2+patients+prematurely+withdrawn+ Groups/were well balanced in/ = 1+pt due+to+consent+withdrawal. terms of/baseline characteristics,/ = 1+pt due+to+AE disease severity and/ previous use/ 1+pt who+refused+to+perform+ of
Slide 8: Good Safety Profile
Good/Safety/Profile • Very consistent with previous clinical studies • No deaths, no malignancies, no opportunistic infections, no significant changes in the laboratory parameters including WBC • No Serious Adverse Reaction, all AE’s of mild to moderate intensity Patients with at least one Treatment
Slide 9: Efficacy data (Day 56)
Efficacy/data/(Day/56) ABX464 (n=20/23) Placebo( n=9/9) p value (PP) PP/ITT PP/ITT Clinical Remission 35% / 30% 11% / 11% 0.16 Endoscopic Improvement 50% / 43% 11% / 11% 0.03 Clinical response 70% / 61% 33% / 33% 0.06 Total Mayo Score Reduction -53% -27% 0.03 Partial Mayo score Reduction -62% -32% 0
Slide 10: Total Mayo Score Day 0 Day 56
Total/Mayo/Score/Day/00 Day/56 10
Slide 11: Partial Mayo Score Day 0 Day 56
Partial/Mayo/Score/Day/00Day/56 11
Slide 12: Mayo Score Results
Mayo/Score/Results/ ABX464:+Fast+onset+of+action+and+clinical+responses+in+patients+who+failed+on+biologics 12
Slide 13: Statistically significant increase in miR-124 expression
Statistically significant increase in miR-124 expression Total blood and Rectal tissue miR=124+expression+ in+Rectal+Biopsies 10 * * 9 7,69 * 8 Fold induction (Ratio) Fold Induction+ (ratio) 7 6 5 4 3 1,46 2 1,00 1 0 Day+0 Day+56+placebo+ Day+56+ABX464 *"p"value"<"0.05"(Treatment"and"time"point) 13
Slide 14: Maintenance Phase: 6 and 9 months interim analysis
Maintenance/Phase:/6/and/90months/interim/analysis// • 22/23+patients+including+ 7+patients+initially+on+placebo+enrolled+ in+the+induction+ phase+(2+countries+did+ not+grant+ regulatory+ clearance+because+of+lack+of+efficacy+data+at+the+time+of+submission) • 3+patients+dropped+ out • One+Lack+of+Ef
Slide 15: Maintenance Phase: Partial Mayo Score
Maintenance+Phase+:+6+and+9+Months+interim+analysis+Partial+Mayo+Score 15
Slide 16: Maintenance Phase: Faecal Calprotectin
Maintenance+Phase+:+6+and++9+Months+interim+analysis+Faecal Calprotectin 16
Slide 17: Maintenance Phase: 9 Months interim analysis
Maintenance+Phase+:+9+Months+interim+analysis • At+9+months,+all+19+patients+were+still+in+study • From+these+19+patients,+18+patients+have+clinical+response+: • 7+patients+(+6+initially+on+ABX464,+1+initially+on+PLO)+were+in+clinical+remission+at+the+ end+of+the+8+weeks+induction+phase.+After+2+mon
Slide 18: Conclusions
Conclusions • New+mechanism+of+action+ORAL+drug+ABX464 • Promising+preclinical+data+in+IBD model • Good+Safety+and+tolerability+of+ABX464+in+UC+patients+and+HIV+program+in+more+than+200+subjects+treated+ (No+Serious+Adverse+Reactions,+no+severe+infections,+no+lymphopenia,+no+neutropenia) • Confirmed
Slide 19: ABX464 next steps
ABX464'next steps • Phase+2b+study+protocol+in+232+patients+with+moderate+to+severe+ulcerative+colitis+ was+submitted+to+regulatory+agencies+in+first+countries • Approved+in+Canada+and+first+EU+countries • Study+open+to+recruitment+of+new+sites • Phase+2a+studies+are+being+submitted+in+Rheumatoid+Ar
Slide 20: Acknowledgements
Acknowledgements Acknowledgements/ • Patients+and+investigators 20