Synact Pharma Ab · OMXSTO:SYNACT
Synact Pharma Ab — Redeye Theme: Autoimmune and inflammatory disease (October 2023)
13 slides from Synact Pharma Ab's conference presentation, Oct 3, 2023
Slide 1: SynAct Pharma - EXPAND Study Update
INFLAMMATION RESOLUTION SynAct Pharma - EXPAND Study Update Redye Theme: Autoimmune and inflammatory disease Torbjörn Bjerke, MD, CEO October 3, 2023
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: Additional data from EXPAND trial demonstrates clear and consistent efficacy in patients with systemic inflammation
Additional data from EXPAND trial demonstrates clear and consistent efficacy in patients with evidence of systemic inflammation at study entry • Data supports resomelagon efficacy and activity in patients with evidence of systemic inflammation – consistent effect seen across all outcome measures • D
Slide 4: Resomelagon (AP1189) is a selective melanocortin agonist with anti-inflammatory and pro-resolution activity
Resomelagon (AP1189) is a selective melanocortin agonist with both anti-inflammatory and pro-inflammation resolution activity MC1R MC2R MC3R MC4R MC5R Steroid dependent effects Targeted by AP1189 and TXP-11 § Resomelagon induces selective stimulation of melanocortin § Exbibits anti-inflammatory acti
Slide 5: EXPAND STUDY P2b study in treatment naive RA patients
EXPAND STUDY P2b study in treatment naive RA patients. Patient Population: § Treatment naïve, eligible for initiation of Resomelagon (AP1189) 100* mg, combination with MTX DMARD treatment (MTX) § CDAI >22 at baseline – min of 6 swollen Placebo, combination with MTX and tender joints § Glucocorticoid
Slide 6: In EXPAND baseline CRP >3mg/L identified as a positive selection factor for resomelagon responsiveness
In EXPAND baseline CRP >3mg/L identified as a positive selection factor for resomelagon responsiveness ACR20 in All and >3mg/L CRP population • The use of baseline CRP >3mg/L as a positive selection 80% factor increases the probability of an AP1189 ACR20 70% response by 16% from 55% in all patients
Slide 7: ACR20 responses in >3mg/L CRP population consistent through CDAI and DAS28-CRP
ACR20 responses seen in >3mg/L CRP population are consistent through CDAI and DAS28-CRP outcome measures ACR20 at week 12 in All and Mean change in CDAI at week 12: Mean change in DAS28 at week 12: >3mg/L CRP populations All and >3mg/L CRP populations All and >3mg/L CRP populations 80% Placebo All P
Slide 8: HAQ Disability Index strongly favored resomelagon in the elevated CRP population
The HAQ Disability Index (HAQ-DI), a quantification of current disability attributed to RA, strongly favored resomelagon in the elevated CRP population Mean change in HAD-DI at 12-weeks in all patients and in Fold improvement in HAQ-DI Score at 12-weeks CRP> 3mg/L at baseline in patients with CRP >3
Slide 9: HAQ-DI section scores show improvements in hand strength and dexterity
The HAQ-DI section scores show disability improvements in areas requiring hand strength and dexterity Mean improvement from baseline to week 12 in overall HAQ-DI and section scores in patients with >3 mg/L CRP at baseline 60% Overall Hand Strength and Dexterity Palcebo 50% AP1189 Tx Effect 40% 30% 2
Slide 10: MRI sub study of wrist and hand joints indicates reduction in joint inflammation
Results from MRI sub study of wrist and hand joints indicates a reduction in assessed joint inflammation that is supported by tender and swollen joint counts Reductions in matched tender and Reduction in DEMRIQ-ME (ml) Reduction in DEMRIQ-IRE swollen joint counts from MRI patients (ml/sec) 5 4 0.09
Slide 11: Lower levels of systemic biomarker C4M indicate decreased collagen IV degradation
Lower levels of systemic biomarker C4M indicate decreased collagen IV degradation in resomelagon treated patients with elevated CRP Baseline and week 12 levels Reduction in C4M • Collagen type IV is a structural matrix C4M ng/ml 35,0 ng/ml protein which contributes to the 380 structural organization
Slide 12: EXPAND Safety: Resomelagon continues to exhibit a favorable safety profile
EXPAND Safety: Resomelagon continues to exhibit a favorable safety profile Treatment Emergent Adverse Events (TEAE) Placebo+ MTX AP1189 100mg + Group (n) Overall (127) (64) MTX (63) Serious Treatment Emergent AEs Patients with ≥ 1 Serious AE n (%) 1 (1.6) 1 (1.6) 2 (1.6) Non-Serious Treatment Emerge
Slide 13: Additional data from EXPAND trial demonstrates clear and consistent efficacy in patients with systemic inflammation
Additional data from EXPAND trial demonstrates clear and consistent efficacy in patients with evidence of systemic inflammation at study entry • Data supports resomelagon efficacy and activity in patients with evidence of systemic inflammation – consistent effect seen across all outcome measures • D
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