Slide 1: SynAct Pharma AB: EXPAND phase 2b top-line data
INFLAMMATION RESOLUTION SynAct Pharma AB Treating Inflammation through Resolution Therapy EXPAND phase 2b - top-line data
Slide 2: Forward Looking Statements
Forward Looking Statements Certain information set forth in this presentation contains “forward-looking information”, including “future-oriented financial information” and “financial outlook”, under applicable securities laws (collectively referred to herein as forward-looking statements). Except fo
Slide 3: Top-line data EXPAND phase 2b study
Top-line data EXPAND phase 2b study • 54.7% for AP1189 vs 55.7% for Placebo in ACR20 score Primary end point was • Subjective assessment very much different from the BEGIN study not achieved • Objective parameters more in line with the BEGIN study Good safety profile • Very favorable safety profile
Slide 4: EXPAND STUDY P2b study in treatment naive RA patients
EXPAND STUDY P2b study in treatment naive RA patients. Patient Population: Treatment naïve, eligible for initiation of Resomelagon (AP1189) 100* mg, combination with MTX DMARD treatment (MTX) CDAI >22 at baseline – min of 6 swollen Placebo, combination with MTX and tender joints Glucocorticoid
Slide 5: The EXPAND study – patient disposition
The EXPAND study – 12 weeks dosing in treatment naïve RA pt with high disease activity 127 Patients Randomized Resomelagon=63 Placebo n=64 Completed n=53 Completed n=61 Discontinued n=10 Discontinued n=3 Withdrawal of content n=5 Withdrawal of content n=1 Adverse event n= 5 Adverse event n=1 Lost in
Slide 6: The EXPAND study – baseline characteristics
The EXPAND study – 12 weeks dosing in treatment naïve RA pt with high disease activity Baseline Characteristics Resomelagon (n=63) Placebo (n=64) Age mean 58.0 55.2 Gender 85.7 87.5 % Females RA- history Weeks (Mean) 42 19 RA % Sero Negative 25.3 17.2 CRP % above normal range 39.6 35.9 CDAI 42.0 40.
Slide 7: EXPAND Primary Safety Endpoint
INFLAMMATION RESOLUTION EXPAND Primary Safety Endpoint Adverse event (AE) monitoring
Slide 8: Safety: Treatment emergent events in the EXPAND study
Safety: Treatment emergent events in the EXPAND study I N F L A M M A T I O N R E S O L U T I O N 88
Slide 9: EXPAND Primary Efficacy Endpoint
INFLAMMATION RESOLUTION EXPAND Primary Efficacy Endpoint Effect of 100 mg resomelagon (AP1189) against placebo in subjects with RA, evaluated by the American College of Rheumatology 20% (ACR20) response rate at week 12
Slide 10: ACR Scores following 12 weeks treatment
The EXPAND study – 12 weeks dosing in treatment naïve RA pt with high disease activity ACR Scores following 12 weeks treatment Percentage of patients 100 80 60 54,7 55,7 40 20 0 Resomelagon (n=53) Placebo (n=61) The study could not identify treatment related effects of resomelagon relative to placeb
Slide 11: EXPAND Study Discussion points
INFLAMMATION RESOLUTION EXPAND Study Discussion points
Slide 12: ACR scoring system – both subjective and objective read-outs
ACR scoring system – both subjective and objective read-outs Subjective Objective read-outs read-outs • Investigator assessment of disease activity (VAS) • Tender Joint Swollen Joints CRP • Patient assessment of disease activity (VAS) • Patients Pain assessment (VAS) • Health Assessment Q. (HAQ) of
Slide 13: EXPAND Study – observations
EXPAND Study – observations • In the EXPAND study reduction in tender and swollen joints in the resomelagon group seems to have been reduced to a degree we could expect from the BEGIN study • The patient and investigator assessment of disease activity in the EXPAND study did not reflect the reductio
Slide 14: RESOLVE Study - Adaptive P2a/b trial in DMARD-IR patients
RESOLVE Study - Adaptive P2a/b trial in DMARD-IR patients Sites in US and Europe under an US- IND- P2a data expected in October Part A – 4 weeks dosing Part B – 12 weeks dosing 3 dose levels of Resomelagon (AP1189) cont. MTX Up to 3 dose levels of Resomelagon (AP1189), cont. MTX Placebo, cont. MTX P
Slide 15: Key differences between RESOLVE and EXPAND studies
Key differences between RESOLVE and EXPAND studies • Disease duration: • Tx naïve - <1yr since diagnosis • DMARD-IR – years since diagnosis • Previous methotrexate use: • Tx naïve – no previous methotrexate use • DMARD-IR – patients have a documented incomplete response to MTX after an adequate cour
Slide 16: DMARDs are time-tested 1st-line RA therapies but many patients do not respond
DMARDs are time-tested 1st-line RA therapies but the majority of treated patients will not achieve a durable response on DMARD monotherapy DMARD-IR: • This is the patient population being studied in RESOLVE Later IR 6-12 Mo • Up to 50% of 1st DMARD Tx will not 16% achieve low disease activity and 70
Slide 17: DMARD-IR: High unmet need and significant commercial opportunity
DMARD-IR: High unmet need and significant commercial opportunity • Currently, DMARD-IR patients are not well served by existing therapies • Advanced therapies like biologics and JAK inhibitors come with serious safety concerns • Payors and insurers can deny and delay access to these very expensive t
Slide 18: Top-line data EXPAND phase 2b study
Top-line data EXPAND phase 2b study • 54.7% for AP1189 vs 55.7% for Placebo in ACR20 score Primary end point was • Subjective assessment very much different from the BEGIN study not achieved • Objective parameters more in line with the BEGIN study Good safety profile • Very favorable safety profile