Synact Pharma Ab · OMXSTO:SYNACT
Synact Pharma Ab — Investor Presentation (February 2021)
37 slides from Synact Pharma Ab's investor presentation, February 2021
Slide 1: Transforming the treatment of severe inflammatory diseases
SynAct Pharma AB (publ) Transforming the treatment of severe inflammatory diseases Stockholm, February 2021
Slide 2: Forward-looking statements
Forward-looking statements The information in this presentation (the “Information”) contains forward-looking statements related to Synact Pharma AB (the “Company”). All statements other than statements of historical facts included in the Information are forward-looking statements. Forward-looking st
Slide 3: SynAct Pharma – Investment Highlights
SynAct Pharma – Investment Highlights Facts and Figures ▪ Focus on developing a novel treatment concept for inflammatory and autoimmune Founded in 2013 diseases by targeting the melanocortin system Listed on Spotlight exchange since 2016 ▪ High unmet need in inflammatory diseases for therapeutics th
Slide 4: 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 TXP
Slide 5: 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 6: SynAct Pharma – Pipeline Overview
SynAct Pharma – Pipeline Overview Next Asset Indication Preclinical Phase I Phase IIa Phase IIb Phase III milestone 2Q21 final Rheumatoid Arthritis readout 2H21 final Nephrotic Syndrome readout AP1189 COVID-19-induced acute 2Q21 final respiratory distress syndrome readout Psoriatic Arthritis* Pharma
Slide 7: Resolution in Inflammation – The New Frontier
Resolution in Inflammation – The New Frontier The Inflammatory Response AP1189 inhibits the AP1189 stimulates inflammatory response the resolution phase Inflammatory response effectively controlled in extent and 1 time – protects tissues and limits damage - + 2 Pathways activated to safely terminate
Slide 8: 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 Steroidal dependent effects Steroidal independent effects Discovery of the family of 5 melanocortin r
Slide 9: AP1189 – First-in-class biased MCR agonist – novel mode of action
AP1189 – First-in-class biased MCR agonist – novel mode of action MC1 receptor activation in transfected cells1 AP1189 X ▪ First-in-class biased melanocortin receptor type 1 and 3 agonist- potent inducer of ERG phosphorylation- weak inducer of cAMP stimulation1 ▪ Homology modelling from recently pub
Slide 10: AP1189 – First-in-class biased MCR agonist in Phase II development
AP1189 – First-in-class biased MCR agonist in Phase II development In vivo effect of AP1189 treatment1 AP1189 X ▪ The compound stimulates resolution of inflammation ▪ The compound has shown treatment effects in a number of experimental disease models, including: ▪ Inflammatory Joint diseases (Rheuma
Slide 11: Current melanocortin-derived therapy and AP1189's differentiation
Current melanocortin-derived therapy and AP1189’s differentiation Melanocortin-derived therapies address high unmet needs ▪ Current melanocortin-derived therapy is unspecific and associated with treatment limiting side effects Criteria for melanocortin- ▪ Despite the unwanted side effect profile, th
Slide 12: AP1189 – Current Phase II Development programs in Rheumatoid Arthritis and nephrotic Syndrome
AP1189 – Current Phase II Development programs in Rheumatoid Arthritis and nephrotic Syndrome Positioning as first line add-on Therapy in Active Disease
Slide 13: AP1189 for treatment of active inflammatory and autoimmune diseases
AP1189- for treatment of Active inflammatory and autoimmune diseases- as applied in current Phase 2 programs 1st line 2nd line Moderate (CDAI 10- AP1189 Potential to delay or reduce Biologic / JAK inhibitors 22) to need for second line treatment or additional DMARD severe (CDAI ≥22) Corticosteroids
Slide 14: Demonstrates Efficacy in Arthritis Models
AP1189 Demonstrates Efficacy in Arthritis Models 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 (0-12) 80% * 80% * 60% 50% 50% 40% Onse
Slide 15: Rheumatoid Arthritis Phase IIa Trial Design
AP1189 – Rheumatoid Arthritis Phase IIa Trial Design Part 1 Part 2 Cohort 1 AP1189 50mg 2:1 randomization AP1189 50mg Interim analysis Final analysis Placebo AP1189 100mg Cohort 2 AP1189 100mg Placebo Placebo 4 weeks 4 weeks Key inclusion criteria: Part 1 patient population: ▪ Severe RA (CDAI score
Slide 16: Rheumatoid Arthritis Phase IIa Interim Analyses
AP1189 – Rheumatoid Arthritis Phase IIa Interim Analyses Responder Rate on CDAI Score Observations from the IDMC ▪ 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 higher for A
Slide 17: AP1189 – Additional positioning as treatment of Active inflammatory disease – Flares
AP1189 – Additional positioning as treatment of Active inflammatory disease – Flares
Slide 18: 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 19: 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 20: Rheumatologists Express a High Degree of Interest in AP1189 to Treat RA Flares
Rheumatologists Express a High Degree of Interest in AP1189 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 melanocorti
Slide 21: AP1189 Product Profile Based Upon P2a RA Data Was Well Received
AP1189 Product Profile Based Upon P2a RA Data Was Well Received “If you've genuinely got a drug that does that without all of the “To be honest, I steroid side effects, then that is never gave a 10 in a hugely helpful. It will be presentation such as something that, presuming that this one, but this
Slide 22: Drivers of Intent to Use
Rheumatologists State Efficacy, Non-Steroidal MoA, Oral Convenience and MC MOA as Drivers of Their Intended Use Efficacy The efficacy as described in the product profile (adapted from P2a RA Part 1 data)was viewed by respondents as being equivalent or near equivalent to steroids Drivers of Intent to
Slide 23: Rheumatologists Described Target Patient Segments For AP1189
Rheumatologists Described 2 Target Patient Segments For AP1189 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 ster
Slide 24: Rheumatologists Identified Flare Opportunities in Other Conditions
Rheumatologists Identified Flare Opportunities in Other Conditions – Multiple Options for Expansion Within Rheumatology Rheumatology Expansion Condition Background (top 6 in alpha order) • Limited treatment options Ankylosing Spondylitis • Flares are common and treated with steroids • High unmet nee
Slide 25: AP1189 in RA – moving forward
AP1189 – in RA – moving forward Development path to Phase 2b clinical development Q4 2020 ▪ Initiation of Phase IIa Part 2 ▪ Continue preclinical development supporting 12 weeks clinical studies Q1 2021 Q2 2021 ▪ Phase 2a study recruitment ▪ Complete preclinical completed followed by key development
Slide 26: AP1189 – Phase II Development in Nephrotic Syndrome
AP1189 – Phase II Development in Nephrotic Syndrome Positioning as alternative to immuno-suppressive Therapy
Slide 27: Nephrotic Syndrome
Nephrotic Syndrome Unmet Need c.150k Prevalence across US and EU ▪ Limited clinical guidelines exist for the proper management of Nephrotic Syndrome ▪ Management consists of therapeutic treatment with diuretics, ACE inhibitors, anti-infectives, lipid-lowering agents, and immunosuppressants Limited T
Slide 28: MC1R-mediated pathways activated in Nephrotic Syndrome
MC1R-mediated pathways activated in Nephrotic Syndrome 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 consisted of ERK1/2 dep
Slide 29: Shows Benefits in Models of Nephritis
AP1189 Shows Benefits in Models of Nephritis 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 hrs 6.000 3.000 0,6 * 0,
Slide 30: Phase IIa Trial in Nephrotic Syndrome
AP1189 – Phase IIa Trial in Nephrotic Syndrome 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 endpoint: Change in 24 hour pr
Slide 31: AP1189 – COVID-19 Patients at risk of developing ARDS
AP1189 – COVID-19 Patients at risk of developing Acute Respiratory Distress Syndrome (ARDS)
Slide 32: 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 33: 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 33 Shortness o
Slide 34: 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 35: Summary
SYNACT JJ PHARMA
Slide 36: SynAct Pharma Investment Highlights
SynAct Pharma Investment Highlights Investment highlights Expected news flow Focus on developing a novel treatment concept for inflammatory and autoimmune diseases by targeting the melanocortin system Q4 2020 ▪ Interim Phase IIa data Part 1 RA ▪ Initiation of Phase IIa Part 2 RA High unmet need in i
Slide 37: Contact
Chairman Dr. Torbjørn Bjerke [email protected] CEO, Jeppe Øvlesen [email protected] Tel.: + 45 2844 7567 CFO, Henrik Stage [email protected] Tel.: + 45 4026 0900 CSO, Thomas Jonassen [email protected] Tel.: + 45 4015 6669 www.synactpharma.com 37
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