Synact Pharma Ab · OMXSTO:SYNACT
Synact Pharma Ab — Investor Presentation (December 2021)
18 slides from Synact Pharma Ab's investor presentation, Dec 2, 2021
Slide 1: 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 Presentation from the investor web cast held by the company on N
Slide 2: Forward Looking Statements - Disclaimer
Forward Looking Statements - Disclaimer 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 statement
Slide 3: 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 a once-daily oral selective melanocortin receptor type 1 and 3 agonist that both eli
Slide 4: AP1189 for treatment of Rheumatoid Arthritis
AP1189 for treatment of Rheumatoid Arthritis • Rheumatoid arthritis (RA) is chronic autoimmune disease with marked joint affection as well as systemic affection. • Between 0.5 and 1% of adults in the developed world have RA • Onset is most frequent during middle age and women are affected 2.5 times
Slide 5: Study design
Study design AP1189 50 mg OD AP1189 50 mg OD Part 1 Part 2 Interim analysis Final analysis Placebo 2:1 randomisation 1:1:1 AP1189 100 mg OD for each cohort AP1189 100 mg OD randomisation Primary safety endpoint Placebo Safety of AP1189 vs placebo Placebo 4 weeks (AEs and SAEs) 4 weeks Adult patients
Slide 6: Results: Patient disposition
Results: Patient disposition Assessed for eligibility (n=157) Reason for Exclusion: Tuberculosis or hepatitis (39%) Rheuma Negative (39%) CDAI < 22 (10%) Uncontrolled concomitant disease (9%) Other (3%) Randomized (n=105) Allocated to AP1189 50 mg Allocated to AP1189 100 mg Allocated to placebo (n=3
Slide 7: Results: baseline characteristics
Results: baseline characteristics 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/Asian/Other (n)
Slide 8: Results: baseline characteristics
Results: baseline characteristics Placebo (n=32)* AP1189 50 mg (n=31)* AP1189 100 mg (n=35)* CDAI 36.3±8.6 36.1±11.0 39.0±9.0 TJC 10.0±3.9 10.3±4.4 11.8±5.0 SJC 13.9±5.6 13.7±6.4 15.0±5.8 DAS-28 5.5±1.0 5.4±0.9 5.7±0.9 Patient Global Assessment (VAS) 6.2±1.2 6.3±1.3 6.4±1.3 Physician Global Assessme
Slide 9: 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 10: Change in Clinical Disease Activity Index (CDAI)
Change in Clinical Disease Activity Index (CDAI) Mean change in CDAI from baseline to Week 4 -40 -6 -8 Change in CDAI score -10 -9,3 -12 -12 -14 -16 -15,5 -18 P<0.04 vs placebo -20 Placebo (n=30) AP1189 50 mg (n=29) AP1189 100 mg (n=32) CDAI, Clinical Disease Activity Index 10
Slide 11: Treatment effects evaluated by CDAI - proportion of patients
Treatment effects evaluated by CDAI - proportion of patients with moderate disease activity end of treatment Proportion of patients with CDAI < 22 70 65 62 60 55 52 Percentage (%) 50 45 40 40 35 30 25 20 Placebo (n=30) AP1189 50 mg (n=29) AP1189 100 mg (n=33) CDAI, Clinical Disease Activity Index 11
Slide 12: Treatment effects evaluated by DAS28 - proportion of patients
Treatment effects evaluated by DAS28 - proportion of patients with at least moderate disease activity at 1-mo Proportion of patients with DAS28 ≤ 5.1 60 51,5 50 40 37,8 Percentage (%) 30 23,3 20 10 0 Placebo AP1189 50 mg AP1189 100 mg DAS-28, Disease Activity Score in 28 joints 12
Slide 13: Treatment effects evaluated by ACR scoring
Treatment effects evaluated by ACR scoring – Proportion of patients with minimum 20/50/70% improvement in disease activity 75 65 55 48 Percentage (%) 45 35 31 25 23 18,2 15 9,1 6,7 3,5 3,3 5 0 -5 ACR20 ACR50 ACR70 Placebo (n=30) AP1189 50 mg (n=29) AP1189 100 mg (n=33) ACR20, ≥20%; ACR50, ≥50%; ACR7
Slide 14: Change in FACIT-Fatigue score
Treatment effects on patient fatigue evaluated by the FACIT-fatigue score at 1-mo 10 9 8 Change in FACIT-Fatigue score 8 7 5,9 6 5 4,8 4 3 2 0 Placebo (n=30) AP1189 50 mg (n=29) AP1189 100 mg (n=33) FACIT, Functional Assessment of Chronic Illness Therapy; 14
Slide 15: Change in pain (patient VAS score)
Treatment effects on patient pain evaluated by VAS Mean change in pain from baseline to Week 4 Change in pain (patient VAS score) -0,60 -0,8 -1 -0,9 -1,2 -1,2 -1,4 -1,6 -1,8 -1,8 -2 Placebo (n=29) AP1189 50 mg (n=29) AP1189 100 mg (n=33) VAS, visual analogue scale 15
Slide 16: Summary
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 with AP1189 a
Slide 17: AP1189: Multiple Opportunities in the Management of RA
AP1189: Multiple Opportunities in the Management of RA ▪ Despite having numerous biologics with multiple MoAs, JAK inhibitors, immunosuppressives and steroids, RA treatment is still an art form ▪ FDA has safety concerns with JAK inhibitors ▪ Rheumatologists tend to treat aggressively but will cycle
Slide 18: Contact details
Chairman Dr. Torbjørn Bjerke tbje@synactpharma.com CEO, Jeppe Øvlesen joo@synactpharma.com Tel.: + 45 2844 7567 CSO, Dr. Thomas Jonassen tj@synactpharma.com Tel.: + 45 4015 6669 CMO, Dr. Anders Dyhr Toft adt@synactpharma.com Tel. +45 4081 7076 www.synactpharma.com 18
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