Synact Pharma Ab · OMXSTO:SYNACT
Synact Pharma Ab — Investor Presentation (March 2022)
36 slides from Synact Pharma Ab's investor presentation, March 2022
Slide 1: SynAct Pharma AB: Resolving Inflammation Through Melanocortin Biology
SynAct Pharma AB Resolving Inflammation Through Melanocortin Biology March 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 Filing CTA Q2 Rheumatoid Arthritis – 2022 First line treatment High level data Q3 2023 Pre-IND meeting Rheumatoid Arthritis – Q2 2022 DMARD-IR IND filing PH2b H2 2022 AP1189 Redesigned
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: Ready for weeks development with once daily dosing with tablets
Ready for 12 weeks development with once daily dosing with tablets Toxicology: AP1189-CS004 STUDY – ORAL • Three Months Tox studies with recovery groups DOSING WITH 100 MG successfully been completed Suspension (n=12) Tablet Acetate (n=12) 350 • NOAEL rat: 100 mg/kg 300 • NOAEL pig: 50 mg/kg AP1189
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: BEGIN P2a POC RA study topline results
BEGIN P2a POC RA study topline results: AP1189 100mg once-daily oral dose group was efficacious and safe • After 1-mo of treatment, the 100mg once-daily oral AP1189 group had: o Significantly better CDAI improvement Vs placebo and that was above the established minimally important clinical differenc
Slide 19: Change in CDAI score
Mean change in CDAI at 1-mo (primary read out) 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 Placebo (n=30) AP1189 50 mg (n=29) AP1189 100 mg (n=33) Place
Slide 20: % of patients improving from severe CDAI to at least moderate disease activity
% of patients improving from severe CDAI to at least moderate disease activity (CDAI ≤22) Proportion of patients with CDAI ≤ 22 ▪ While the study showed a clear dose dependent reduction in mean 70 change in CDAI (the primary read out) in the AP1189 treated patients, 65 62 reaching statistically sign
Slide 21: Proportion of patients achieving ACR20/50/70 response at 1-mo
Proportion of patients achieving ACR20/50/70 response at 1-mo 70 ACR 20/50/70 Response Rates * 60,6 60 50 Percentage (%) 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 Robust 1-Mo ACR20/50/70 response rates for 100mg AP1189
Slide 22: Change in DAS28 (CRP) - subset of 'very active'
Change in DAS28 (CRP) - subset of ‘very active’ with >5.1 score at baseline Patients going from ‘very active’ (>5.1) to Mean Change in DAS28 from Baseline to Week 4 80 ‘active’ (5.1-3.2) 0 70 68 Change in DAS28 60 61,1 Percentage (%) 50 40 -1 -0,9 -0,9 30 36,8 -1,3 20 10 0 -2 Placebo (n=19) AP1189 5
Slide 23: Physician global disease assessment and pain VAS change
% improvement in physician global disease assessment (VAS) and and mean change in pain VAS score Change in Physician Global Disease Assessment Mean reduction in pain (VAS-score) 0 -0,6 -5 -10 -0,8 -15 -11 -0,9 -1 Percentage (%) -20 -1,2 -25 -1,2 -30 -1,4 -35 -32 -1,6 -40 -45 -1,8 -44 -1,8 -50 P<0.01
Slide 24: Mean change in FACIT-Fatigue score at 1-mo
Mean change in FACIT-Fatigue score at 1-mo 10 Mean change in FACIT-Fatigue score from baseline 9 8 8 Mean Change in Score 7 5,9 6 5 4,8 4 3 2 Placebo (n=30) AP1189 50 mg (n=29) AP1189 100 mg (n=33) Mean change in 100mg group is 2x the established minimally important clinical difference (MCID)+ (+) C
Slide 25: 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 AEs, n (%) 0 0 0 0 Discontinuatio
Slide 26: AP1189 1-mo ACR20 scores are comparable to JAKs
AP1189 100mg 1-mo ACR20 scores are comparable to JAKs ACR20 in MTX-Naïve P3 trials - Response rates should increase over time with 3-mo dosing as with JAKs 90 1-mo actual and 3-mo proj. ACR20 Rates Range of 80 3-mo JAK data (75-80%) 70 Range of 60 1-mo JAK data ACR20 (%) (58-65%) 50 Projected 61%* A
Slide 27: 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 28: AP1189 - Rheumatoid Arthritis
AP1189 -Rheumatoid Arthritis Positioning and next development steps
Slide 29: The current treatment paradigm for RA leaves significant potential for new 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 30: 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 31: 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 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: AP1189 in Rheumatoid Arthritis - 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 With JAK Inhibitors Create an 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