Slide 1: SynAct Pharma AB: Treating Inflammation through Resolution Therapy
INFLAMMATION RESOLUTION SynAct Pharma AB Treating Inflammation through Resolution Therapy BIO Boston June 2023 CEO Torbjörn Bjerke, MD
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: SynAct Pharma – In Brief
SynAct Pharma – In Brief SynAct Pharma is a clinical stage biotechnology company focused on resolving inflammation through melanocortin biology to treat inflammatory and autoimmune diseases Oral small molecule, AP1189, is currently in active Phase 2 development for rheumatoid arthritis (RA) and
Slide 4: SynAct Pharma – Pipeline overview
SynAct Pharma – Pipeline overview Asset Indication Pre-clinical Phase I Phase IIa Phase IIb Phase III Rheumatoid Arthritis Severe treatment-naïve with MTX Rheumatoid Arthritis DMARD-IR Resomelagon (AP1189) Nephrotic syndrome (iMN) Virus- Induced Respiratory Insufficiency Prevention of organ failures
Slide 5: Selective melanocortin agonists with anti-inflammatory and pro-resolution activity
SynAct is developing selective melanocortin agonists with both anti-inflammatory and pro-inflammation resolution activity MC1R MC2R MC3R MC4R MC5R Steroid dependent effects Targeted by AP1189 and TXP-11 Resomelagon induces selective stimulation of melanocortin Exbibits anti-inflammatory activity
Slide 6: RA affects about 1% of the global population; remission can remain elusive
RA affects about 1% of the global population, and while there are several classes of approved therapies remission can remain elusive DMARD patients do not 1% Global population affected 70% achieve remission and require therapy escalation Biologics patients do not achieve $30b Expected global market
Slide 7: Resomelagon demonstrated significant treatment effects in severe treatment-naïve RA in BEGIN
Resomelagon (AP1189) demonstrated significant treatment effects in patients with severe treatment-naïve RA in the 4-week BEGIN P2a clinical trial Phase 2a study in treatment naive RA patients with high disease activity (CDAI >22 at randomization) in combination with MTX with 4 weeks treatment Mean c
Slide 8: Improvements in DAS28 (CRP) and FACIT-Fatigue Scores
Meaningful improvements were also seen in DAS28 (CRP) and FACIT-Fatigue Scores 80 Responders going from severe to at 10 Mean change in FACIT-Fatigue score least moderate (>5.1 to <5.1 at 1-mo) 70 9 68 8 60 8 61,1 Mean Change in Score 50 7 Percentage (%) 40 5,9 6 36,8 4,8 30 5 20 4 10 3 0 2 Placebo (
Slide 9: 4-Week daily AP1189 dosing was safe and well tolerated in BEGIN
4-Week daily AP1189 dosing was safe and well tolerated in the BEGIN study I N F L A M M A T I O N R E S O L U T I O N 9
Slide 10: EXPAND Study: P2b in treatment naive RA patients
EXPAND STUDY P2b study in previous treatment naive RA patients. Recruitment completed in April 2023 - Patient Population: Previous treatment naïve, eligible for Resomelagon (AP1189) 100* mg, combination with MTX initiation of DMARD treatment (MTX) CDAI >22 at baseline – min of 6 swollen Placebo,
Slide 11: AP1189 Adaptive P2 trial design in DMARD-IR patients
AP1189- Adaptive P2 trial design in DMARD-IR patients Currently recruiting in US and Europe under an US- IND- Data on part A in H2 2023 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, con
Slide 12: Emerging Resomelagon clinical profile supports continued RA development
The emerging Resomelagon (AP1189) clinical profile supports continued RA development for potential broad utility Emerging Resomelagon Clinical profile • New oral tablet being used in both EXPOAND and RESOLVE • Once-Daily Oral Dosing • Oral convenience for early lines of therapy • Efficacy seen at 2-
Slide 13: Resolving inflammation without immunosuppression for broad use in RA
Resomelagon (AP1189) can resolve Inflammation without causing immunosuppression which may make it potentially suitable for broad use in RA • Most approved RA therapies are immunosuppressive and have black boxed warnings of potentially serious and possibly fatal serious adverse event reactions • Reso
Slide 14: Treatment naïve RA patients present with high activity almost 50% of the time
Treatment naïve RA patients present with high activity and other poor prognostic indicators almost 50% of the time Highly-Active Naïve: • Studied in BEGIN and EXPAND studies • Highly active disease is the dominating Present without high Present with high poor prognostic indicator (PPI) in ACR and ac
Slide 15: DMARDs are 1st-line RA therapies but most patients lack durable response
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 16: US rheumatologists state strong interest and intent to use in DMARD-IR and anti-TNF-IR
US high-volume rheumatologists stated a strong interest and high intent to use in both DMARD-IR and anti-TNF-IR RA patients Rheum Interest in AP1189 for DMARD-IR 100% 80% “Oh man. I'd love to use this up front. I'd love to use it right after 60% methotrexate. I'd love to use it before. I'd love to s
Slide 17: Beyond RA – Interest in additional rheumatology diseases
Resomelagon (AP1189) - Beyond RA – Rheumatologists express significant Interest for development in additional rheumatology diseases Additional rheumatology diseases-of-interest for Resomelagon (AP1189) Psoriatic arthritis Psoriatic Arthritis 11 **Use may depend on if Product X improves both dermal s
Slide 18: Thank you
INFLAMMATION RESOLUTION Thank you