Synact Pharma Ab · OMXSTO:SYNACT
Synact Pharma Ab — Investor Presentation (February 2022)
36 slides from Synact Pharma Ab's investor presentation, February 2022
Slide 1: Resolving Inflammation Through Melanocortin Biology
SynAct Pharma AB Resolving Inflammation Through Melanocortin Biology February 2022
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 – Highlights
SynAct Pharma – Highlights ▪ SynAct Pharma is focused on the development of novel and first-in-class agonists that target the melanocortin system Facts and figures ▪ There is high unmet need in autoimmune and inflammatory diseases for efficacious and safe therapies – current therapies can present si
Slide 4: Leadership
SYNACT JJ PHARMA Leadership
Slide 5: SynAct Pharma – Experienced Management
SynAct Pharma – Experienced Management Jeppe Øvli Øvlesen, MBA – CEO Patrik Renblad, MSc – CFO ▪ >20 years of CEO experience ▪ >20 years’ experience from finance ▪ Founding Board Member of more than roles in pharma 10 biotech/medtech companies ▪ Former head of R&D Finance at LEO ▪ Co-founder of TXP
Slide 6: SynAct Pharma – Senior Advisors
SynAct Pharma – Senior Advisors Scientific Advisory Board Henrik Stage, MSc – Senior Advisor to CEO Mauro Perretti, Professor ▪ >25 years’ experience in biotech and ▪ Professor of immunopharmacology and dean of science (Dean financial industry of Research) at Barts and London School of Medicine ▪ CF
Slide 7: SynAct Pharma – Board of Directors
SynAct Pharma – Board of Directors Torbjørn Bjerke, MD – Chairman Thomas Jonassen, MD – Board Member, Founder ▪ >25 years track record from pharma ▪ Associate Professor, KU in Denmark industry as Head, R&D and CEO ▪ Visiting Professor, WHRI, UK (private and public), BD ▪ Co-founder of TXP Pharma and
Slide 8: SynAct Pharma – Pipeline overview
SynAct Pharma – Pipeline overview Next Asset Indication Preclinical Phase I Phase IIa Phase IIb Phase III milestone IND filing with Rheumatoid arthritis FDA H1 2022 Ongoing Phase IIa Nephrotic syndrome being re- designed AP1189 Key data from virus-induced Virus-induced respiratory hyperinflamm insuf
Slide 9: Inflammation Resolution can correct dysregulated inflammation without inducing immunosuppression
Inflammation Resolution can correct dysregulated inflammation without inducing immunosuppression The inflammatory response 1 Inflammatory response effectively controlled in extent and time – protects tissues and limits damage 2 Pathways activated to safely terminate the inflammatory response and pro
Slide 10: AP1189: A First-in-Class Selective Melanocortin Receptor 1 and 3 Agonist
AP1189: A First-in-Class Selective Melanocortin Receptor 1 and 3 Agonist MC1R MC2R MC3R MC4R MC5R Steroid dependent effects Targeted by AP1189 ▪ AP1189 was designed to activate melanocortin receptors 1 and 3 ▪ AP1189 exbibits anti-inflammatory activity through stimulation of (MC1R and MC3R), which a
Slide 11: AP1189 – First-in-Class Selective and Biased MCR 1 and 3 Agonist
AP1189 – First-in-Class Selective and Biased MCR 1 and 3 Agonist MC1 receptor activation in transfected cells1 X X AP1189 selectively engages ERK Pathway 11 1. Montero-Melendez et al: J Immunol. 194:3381-8, 2015; 2. Data from Completed Phase 1 study in healthy volunteers; 2. Yu, J. et al. Determinat
Slide 12: Phase 1 Program Supports Once-Daily Oral Dosing
Phase 1 Program Supports Once-Daily Oral Dosing AP1189 X • SAD and MAD studies have been conducted in healthy Male Volunteers with additional dosing in a cohort of Postmenopausal Women using a Suspension of PK profile following repeat dosing in man1 AP1189/Placebo for oral administration 1 200 50 mg
Slide 13: Update on PK on tablet and preclinical development
Update on PK on tablet and preclinical development Toxicology: • Three Months Tox studies with recovery groups AP1189-CS004 STUDY – ORAL successfully been completed DOSING WITH 100 MG • NOAEL rat: 100 mg/kg Suspension (n=12) Tablet Acetate (n=12) 350 • NOAEL pig: 50 mg/kg 300 AP1189 NG/ML PLASMA • N
Slide 14: The BEGIN study
The BEGIN study A double-blind, multi-centre, two-part, randomized, placebo-controlled study of the safety, tolerability, and efficacy of 4 weeks of treatment with AP1189 in early rheumatoid arthritis patients with active joint disease Completed Q4 2021
Slide 15: BEGIN: P2a POC 4-week study of AP1189 + MTX in severely active early RA
BEGIN: P2a POC 4-week study of AP1189 + MTX in severely active early RA Study Population Primary safety endpoint Primary efficacy endpoint Adult patients (aged 18 to 85 years) with • Mean change in CDAI or Safety of AP1189 vs placebo (AEs and SAEs) severe RA defined as CDAI >22, who are • % of patie
Slide 16: Baseline characteristics of randomized population
Baseline characteristics of randomized population Placebo (n=34) AP1189 50 mg (n=35) AP1189 100 mg (n=36) Female, % 79.4 77.1 77.8 Age (years) Mean±SD 56.4±13.1 56.4±13.1 55.3±13.9 Median (range) 61 (26–78) 57 (28–79) 56.5 (27–77) 18–64 years/65–84 years (%) 73.5/26.5 71.4/28.5 72.2/27.8 Race, White
Slide 17: Baseline disease activity in efficacy assessment population
Baseline disease activity in efficacy assessment population Placebo (n=30)* AP1189 50 mg (n=29)* AP1189 100 mg (n=33)* CDAI 36.7±8.7 36.1±9.7 39.5±9.1 SJC 10.4±379 10.2±3.9 12.1±4.9 TJC 13.7±6.1 13.6±6.0 15.2±6.0 DAS-28 5.5±1.0 5.4±0.8 5.7±0.9 Patient Global Assessment (VAS) 6.5±1.8 6.1±2.1 5.8±2.2
Slide 18: Change in Clinical Disease Activity Index (CDAI)
Change in Clinical Disease Activity Index (CDAI) CDAI at Baseline and End of Treatment Mean change in CDAI from baseline to Week 4 40 39,5 0 35 36,7 36,1 Change in CDAI score 30 -5 25 27,4 24,2 23,9 20 -10 -9,3 15 -12 10 -15 5 -15,5 0 -20 p<0.04 vs placebo Placebo (n=30) AP1189 50 mg (n=29) AP1189 1
Slide 19: % of patients improving from severe CDAI to at least moderate
% of patients improving from severe CDAI to at least moderate (CDAI ≤22) ▪ While the mean CDAI change between placebo and 100mg Proportion of patients with CDAI ≤ 22 was significant, when the change in CDAI is assessed by 70 looking at the % of patients going from severe CDAI to 65 62 moderate or lo
Slide 20: % of patients achieving ACR 20/50/70 Responses
% of patients achieving ACR 20/50/70 Responses Patients Meeting ACR 20/50/70 Response Levels 80 70 60,6 60 Percentage (%) 50 40 37,9 33,3 30 24,2 20 13,3 12,1 10 6,9 3,3 0 0 Placebo (n=30) AP1189 50 mg (n=29) AP1189 100 mg (n=33) ACR20 ACR50 ACR70 ACR response data has been updated following recalcu
Slide 21: Proportion of patients with at least moderate DAS28 disease activity
Proportion of patients with at least moderate DAS28 disease activity and % improvement in physician global disease assessment (VAS) Proportion of patients with DAS28 ≤ 5.1 Change in Physician Global Disease Assessment 60 0 51,5 -5 50 -10 37,8 -11 Percentage (%) 40 -15 Percentage (%) -20 30 -25 23,3
Slide 22: Mean change in FACIT-fatigue score and mean change in pain VAS score
Mean change in FACIT-fatigue score and mean change in pain VAS score Mean improvement in Fatigue (FACIT Score) Mean reduction in pain (VAS-score) -0,6 10 9 -0,8 8 8 -1 -0,9 7 -1,2 5,9 -1,2 6 -1,4 5 4,8 -1,6 4 -1,8 3 -1,8 2 -2 Placebo (n=30) AP1189 50 mg (n=29) AP1189 100 mg (n=33) Placebo (n=30) AP1
Slide 23: Efficacy measures from BEGIN trial support continued development of AP1189 in RA
Efficacy measures from BEGIN trial support continued development of AP1189 in RA • 100mg of once-daily AP1189 provided a consistent response across all disease measures including CDAI (primary endpoint), DAS28, and FACIT-Fatigue and ACR response • 100 mg 1-mo ACR response data is comparable to 1-mo
Slide 24: Primary safety endpoint: AEs
Primary safety endpoint: AEs Placebo (n=32) AP1189 50 mg (n=31) AP1189 100 mg (n=35) Total (n=98) SAEs, n (%) 0 0 0 0 AEs, n reported from baseline and on 21 38 27 86 AE severity (mild/moderate/severe) 18/2/1 26/12/0 22/5/0 66/19/1 Discontinuation due to IMP related 0 0 0 0 AEs, n (%) Discontinuatio
Slide 25: BEGIN study summary
BEGIN study summary • In this 4-week study, patients treated once-daily with 100 mg AP1189 achieved a significantly greater reduction in mean Clinical Disease Activity Score (CDAI) as compared to placebo • Change in disease activity from severe to moderate was numerically higher in groups treated wi
Slide 26: AP1189 - Rheumatoid Arthritis
AP1189 -Rheumatoid Arthritis Positioning and next development steps
Slide 27: The current treatment paradigm for RA leaves significant potential for new meaningful therapies
The current treatment paradigm for RA leaves significant potential for new meaningful therapies RA diagnosis Unmet need in the RA treatment paradigm DMARD monotherapy (typically methotrexate) ▪ Rheumatologists tend to treat aggressively with the variety of treatment options available, but RA treatme
Slide 28: AP1189 has the potential to be positioned for several potential uses in RA
AP1189 has the potential to be positioned for several potential uses in RA Multiple RA Positioning Opportunities Emerging AP1189 Clinical profile ▪ The emerging AP1189 clinical profile supports RA development at several treatment inflection points: • Once-Daily Oral Dosing – new oral solid formulati
Slide 29: Rheumatologists expressed high degree of interest in AP1189 in DMARD-IR
Rheumatologists expressed high degree of interest in AP1189 in DMARD-IR Rheum Interest in AP1189 in DMARD-IR 10 The combination of efficacy, safety, tolerability and 8 oral convenience positions AP1189 well for 6 4 8,9 9 DMARD-IR Recent FDA labelling actions with JAKs in RA reduces direct competitio
Slide 30: Patients treated with DMARDS-only represents the largest patient segment
Patients treated with DMARDS-only represents the largest patient segment with over 860K US RA patients US Tx RA Patients: Maintenance Therapy 400 364 ▪ Across all patient severity groups, DMARDs DMARD-only 350 are used without any advanced therapies in anti-TNF over 60% of patients 305 Other bio 300
Slide 31: Rheumatologists express high degree of interest in AP1189 based on BEGIN Part 1 data
Rheumatologists express high degree of interest in AP1189 based on the BEGIN Part 1 data Rheumatologist interest to use AP1189 on a scale of 1 to 10 ▪ Rheumatologists reacted very favourably to the product 10 profile for AP1189 based on Part 1 data from BEGIN 9 ▪ US respondents were familiar with me
Slide 32: High Volume US Rheumatologists Reacted Very Favorably to the AP1189 Profile
High Volume US Rheumatologists Reacted Very Favorably to the AP1189 Profile Respondents were all pleased that so many of their unmet needs were addressed with the AP1189 Profile: Novel MOA Oral ROA Clean Safety Profile Potential to be combined with other advanced therapies A We know from oncology…th
Slide 33: High level milestones for 2022
AP1189 as novel compound treatment of Rheumatoid Arthritis- High level milestones for 2022 Q2 2022 ▪ Following interaction with FDA finalize Phase 2b clinical study design and open IND Q4 2021 H2 2022 ▪ Report BE data on new tablet ▪ Initiate dosing in first Phase formulation- aimed for further 2b s
Slide 34: Appendix
SYNACT JJ PHARMA Appendix
Slide 35: Safety Concerns That Have Arisen With JAK Inhibitors Create a Tangible Opportunity for AP1189
Safety Concerns That Have Arisen With JAK Inhibitors Create a Tangible Opportunity for AP1189 in RA Recent developments with JAK inhibitors ▪ Based on a review of a large randomized clinical trial, the FDA has concluded that there is an increased risk of serious cardiovascular-related events such as
Slide 36: Rheumatologists Describe Two Target Patient Segments for AP1189
Rheumatologists Describe Two 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 receiving long-t
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