Synact Pharma Ab · OMXSTO:SYNACT
Synact Pharma Ab — Kempen Life Sciences Conference 2021
30 slides from Synact Pharma Ab's conference presentation, May 2021
Slide 1: SynAct Pharma AB: Transforming the Treatment of Severe Inflammatory Diseases
SynAct Pharma AB Transforming the Treatment of Severe Inflammatory Diseases Kempen Life Sciences Conference May 2021 CONFIDENTIAL
Slide 2: SynAct Pharma – Highlights
SynAct Pharma – Highlights ▪ SynAct Pharma is focused on the development of novel and first in Facts and Figures class agonists that target the melanocortin system Founded in 2013 ▪ Our lead drug candidate AP1189 is an oral selective melanocortin agonist that both elicits anti-inflammatory effects a
Slide 3: SynAct Pharma – Experienced Management
SynAct Pharma – Experienced Management Jeppe Øvli Øvlesen, MBA – CEO Henrik Stage, MsC – CFO ▪ >20 years of CEO experience ▪ >25 years experience from Biotech ▪ Founding Board Member of more than and financial industry 10 biotech/medtech companies ▪ Former CEO and CFO at Santaris ▪ Co-founder of e.g
Slide 4: SynAct Pharma – Board of Directors
SynAct Pharma – Board of Directors Torbjørn Bjerke, MD – Chairman Thomas Jonassen, MD – Co-founder & CSO ▪ >25 years track record from Pharma ▪ Member, Board of Directors industry as Head R&D and CEO ▪ Associate Professor, KU in Denmark (private & public) ▪ Visiting Professor, WHRI, UK ▪ Co-founder
Slide 5: SynAct Pharma – Pipeline Overview
SynAct Pharma – Pipeline Overview Next Asset Indication Preclinical Phase I Phase IIa Phase IIb Phase III milestone Q321 Top Rheumatoid Arthritis Line 2H21 Top Nephrotic Syndrome Line AP1189 COVID-19-induced acute 2Q21 Top respiratory distress syndrome Line Psoriatic Arthritis* Pharmacology program
Slide 6: Inflammation Resolution – A New Frontier
Inflammation Resolution – A New Frontier AP1189 inhibits the The Inflammatory Response AP1189 stimulates inflammatory the resolution 1 Inflammatory response effectively controlled in extent response phase and time – protects tissues and limits damage - + 2 Pathways activated to safely terminate the
Slide 7: The Melanocortin System and its Role in Inflammation
The Melanocortin System and its Role in Inflammation Melanocortin Receptor Family Melanocortin is activated in inflammatory diseases MC1R MC2R MC3R Pro-inflammatory stimulus Apoptotic body MC4R MC5R Steroid dependent effects Steroid independent effects Discovery of a family of 5 melanocortin recepto
Slide 8: AP1189 – First-in-Class Selective and Biased MCR 1 and 3 Agonist
AP1189 – First-in-Class Selective and Biased MCR 1 and 3 Agonist AP1189 MC1 receptor activation in transfected cells1 X • AP1189 was designed to preferentially activate melanocortin receptors 1 and 3 (MC1R and MC3R) which are believed to be responsible for direct immunomodulatory effects ▪ Important
Slide 9: AP1189: Oral Convenience and Targeted Selectivity Within a Proven Mechanism
AP1189: Oral Convenience and Targeted Selectivity Within a Proven Mechanism ▪ Melanocortin therapies have reported efficacy in refractory patients across a range of diseases and systems Key Features Acthar Gel & ▪ Despite this promising activity, significant limitations AP1189 Generics around access
Slide 10: AP1189 – Rheumatoid Arthritis
AP1189 – Rheumatoid Arthritis Immune Resolution Without Immunosuppressive and Steroid Safety Issues
Slide 11: AP1189 for Rheumatoid Arthritis: Pre-Clinical Dataset Supports Clinical Development
AP1189 for Rheumatoid Arthritis: Pre-Clinical Dataset Supports Clinical Development Collagen-induced arthritis K/BxN-induced arthritis Combination Treatment with (30mg/kg, p.o.) (25/50mg/kg, i.p.) Methotrexate Cumulated disease score 100% Proportion with severe clinical signs (%) Clinical score (0-1
Slide 12: RA P2a POC Study: Phase 2a Study in Early RA Patients
RA P2a POC Study: Phase 2a Study in Early RA Patients With Severe Disease Activity Part 1 Part 2 AP1189 50mg 1:1:1 randomization 2:1 randomization AP1189 50mg (for each cohort) Interim analysis Final analysis Placebo AP1189 100mg AP1189 100mg Placebo Placebo 4 weeks Daily PO Dosing 4 weeks Daily PO
Slide 13: RA P2a POC Study: Phase 2a Part 1 – Up to 75% Week 4 Response Rate
RA P2a POC Study: Phase 2a Part 1 – Up to 75% Week 4 Response Rate Response Rate on at 4 Weeks Observations from the DSMB ▪ No concerns about safety with no reports of any serious adverse events ▪ The overall frequency of adverse events is comparable between the two treatment groups and slightly hig
Slide 14: RA P2a POC Study: Study to be completed and reported in H2, 2021
RA P2a POC Study: Study to be completed and reported in H2, 2021 Q4 2021 ▪ Presentation at ACR 2021 ▪ Regulatory advice on Phase 2b development ▪ Bioequivalence data on tablet Q4 2020 H1 2022 ▪ Initiation of Phase IIa Part ▪ Initiate Phase 2b ▪ Continue preclinical work supporting 12 week studies Q3
Slide 15: AP1189 – Big Market Opportunity in the Treatment of Flares in RA
AP1189 – Big Market Opportunity in the Treatment of Flares in RA
Slide 16: RA Tx Armamentarium is Broad But Remission Can Be Elusive and Short-Lived
RA Tx Armamentarium is Broad But Remission Can Be Elusive and Short-Lived ▪ Despite having numerous biologics with multiple MoAs, JAK inhibitors, immunosuppressives and steroids, RA treatment is still an art form ▪ Rheumatologists tend to treat aggressively but will cycle within class and to new MoA
Slide 17: Tx Changes in RA are Driven by Periods of Acute Disease Activity – Disease Flares
Tx Changes in RA are Driven by Periods of Acute Disease Activity –Disease Flares A 3-Year Study of 700+ RA Patients ▪ While ‘Treat to Target’ is remission, periods of acute Indicates The High Frequency of Flares1 disease activity or flares are common Patients Report 3-4 Flares/Yr on Average ▪ Rheuma
Slide 18: Rheumatologists Express a High Degree of Interest in 1189 to Treat RA Flares
Rheumatologists Express a High Degree of Interest in 1189 to Treat RA Flares Rheumatologist Interest to Use 10 ▪ We conducted 1:1 interviews with high patient volume rheumatologists to explore unmet needs around the treatment of 9 RA disease flares 8 ▪ US respondents were familiar with melanocortin
Slide 19: Rheumatologists Described Target Patient Segments For 1189
Rheumatologists Described 2 Target Patient Segments For 1189 Segment Description 7 MM Segment Size • Patients who experience multiple flares per year (4+) • ~15% of patients1 Frequently Flaring • Typically experience low disease activity between flares • >2M flares/year2 • Can be on long-term steroi
Slide 20: AP1189 for Rheumatoid Arthritis: Several Positioning and Development Strategies
AP1189 for Rheumatoid Arthritis: Several Positioning and Development Strategies Current P2a POC Study in Treatment Acute Use ‘Flare’ Positioning Naive ⎯ Target patients with flares experiencing severe acute disease activity ⎯ 4-week trial in treatment naive patients or refractory patients with ongoi
Slide 21: AP1189 – Idiopathic Membranous Nephropathy (iMN)
AP1189 – Idiopathic Membranous Nephropathy (iMN) Immune and Structural Resolution Without Immunosuppression
Slide 22: iMN P2a POC Study: Melanocortins Directly Improve Podocyte Architecture
iMN P2a POC Study: Melanocortins Directly Improve Podocyte Architecture MC1R & Nephrotic Syndrome ▪ MC1R expression is increased in nephrotic syndrome, both in rat models and in humans ▪ MC1R agonism induced protection of podocytes from stress fiber loss ▪ Actin stabilization through the MC1R consis
Slide 23: iMN P2a POC Study: Pre-Clinical Dataset Supports Clinical Development
iMN P2a POC Study: Pre-Clinical Dataset Supports Clinical Development Vehicle (n=12) Membranous nephropathy rat model (passive Heymann Nephritis) AP1189 (n=12) Creatinine Clearance (ml/min/g KW) Albumin excretion rate Reduction in AER (day 14-42) 1,0 8.000 4.000 0,8 † umol/24 hrs umol/24 hrs umol/24
Slide 24: iMN P2a POC Study: Targeting Proteinuria in Moderate-to-Severe iMN Patients
iMN P2a POC Study: Targeting Proteinuria in Moderate-to-Severe iMN Patients ACE – inhibitor treatment 2:1 randomization Final analysis AP1189 100mg Follow up Placebo Follow up 4 weeks 4 weeks 24 hour urine 24 hour urine 24 hour urine collection collection collection Key inclusion criteria: Primary e
Slide 25: AP1189 – COVID-19 Associated ARDS
AP1189 – COVID-19 Associated ARDS Patients at risk of developing Acute Respiratory Distress Syndrome (ARDS)
Slide 26: Macrophages as a potential target for AP1189 treatment in Covid-19 infection
Macrophages as a potential target for AP1189 treatment in Covid-19 infection (and other viral infections associated with hyper-inflammatory responses) Macrophages play a role in COVID-19 hyper-inflammation AP1189 targets key pathways in hyper-inflammation COVID-19 infection is associated with severe
Slide 27: COVID-19: Disease development and AP1189's fit in treatment
COVID-19: Disease development and AP1189’s fit in treatment Stage I Stage II Stage III Early Infection Pulmonary Phase Hyperinflammation Phase IIA IIB Severity of Illness Viral Response Phase Patient Inflammation Phase Time Course Treatment Options Fever, dry cough, headache, diarrhea 27 Shortness o
Slide 28: AP1189 as an add-on therapy in COVID-19 infected patients
AP1189 as an add-on therapy in COVID-19 infected patients Open label Analysis Interim (n=6) AP1189 100mg QD Up to 2 weeks 2:1 randomization Final analysis AP1189 100mg QD n = 54 Placebo Up to 2 weeks Key inclusion criteria: Key secondary endpoints: ▪ Positive COVID-19 infection ▪ Rate of ICU admissi
Slide 29: SynAct Pharma Highlights
SynAct Pharma Highlights ▪ Company strategy is focused to become the leader within Milestones inflammation resolution to treat inflammatory and autoimmune diseases with significant medical need Q4 2020 ▪ Reporting of interim data Phase IIa data RA ▪ AP1189 is an oral selective melanocortin agonist t
Slide 30: Chairman Dr. Torbjørn Bjerke, CEO Jeppe Øvlesen contact details
Chairman Dr. Torbjørn Bjerke tb@synactpharma.com CEO, Jeppe Øvlesen joo@synactpharma.com Tel.: + 45 2844 7567 CSO, Dr. Thomas Jonassen tj@synactpharma.com Tel.: + 45 4015 6669 www.synactpharma.com 30