Argenica Therapeutics Ltd · ASX:AGN
Argenica Therapeutics — Stroke 2023 Scientific Conference (Stroke Society of Australasia and Smart Strokes Joint A
17 slides from Argenica Therapeutics's conference presentation, Aug 24, 2023
Slide 1: Argenica to present ARG-007 data at Stroke 2023 Scientific Conference
ASX ANNOUNCEMENT ARGENICA TO PRESENT ARG-007 DATA AT STROKE 2023 SCIENTIFIC CONFERENCE Perth, Australia; 24 AUGUST 2023 - Argenica Therapeutics Limited (ASX: AGN) (“Argenica” or the “Company”), a biotechnology company developing novel therapeutics to reduce brain tissue death after stroke and other
Slide 2: Phase 1 study of single ascending dose of ARG-007 in healthy participants
A Phase 1, Double-Blind, Randomized, Placebo- Controlled, Sequential-Group study to Assess the ARGENICA THERAPEUTICS Safety, Tolerability, and Pharmacokinetics of Single Ascending Dose of ARG-007 in Healthy Participants David Blacker A.M., Andrew Redfern, Meghan Thomas, Samantha South, Neville Knuck
Slide 3: ARGENICA THERAPEUTICS
This presentation has been prepared by Argenica Therapeutics Limited and its related entities (the “Company”) and is not an offer document. It does not purport to contain all the information that a prospective investor may require in connection with any potential investment in the Company. You shoul
Slide 4: Our lead peptide is ARG-007
• Our lead peptide is ARG-007 • 18 Arginine • Net charge = +18 ARGENICA THERAPEUTICS 3 www.argenica.com.au
Slide 5: CARPs are commonly used as cell penetrating peptides
CARPs are commonly used as cell penetrating peptides TAT Cargo GRKKRRQRRR Can enter cells and cross the blood-brain-barrier Peptide Into cells or across BBB Used as carrier molecules to deliver agents into the Central Nervous GRKKRRQRRR System. Protein One of the most commonly used CARPs is
Slide 6: ARG-007 mechanisms of neuroprotection
Astrocytes: MMP9 activity3 Prevents Ca2+ influx1 ARGENICA THERAPEUTICS Blocks inflammation4 Restores mitochondrial membrane potential2 5 www.argenica.com.au 1Edwards et al., 2018. Mol Brain. 11(1):8. 2MacDougall et al., 2020. Molecules. 25(13):2977. 3Kenna et al., 2020. Neurochem Res 45(5):1215-1229
Slide 7: Participants, location, duration and design
PARTICIPANTS LOCATION DURATION DESIGN ARGENICA THERAPEUTICS 4 cohorts, with each cohort receiving a different dose of Single site study conducted at First healthy adult dosed on Double-blind, randomised ARG-007 (8 participants in the Linear Clinical Research 17th October 20221, forth and study where
Slide 8: Screening, randomisation and dosing cohorts
Screened • 95 subjects screened N = 95 • 32 randomized: Excluded / Not randomised N = 38 excl/ incl criteria • Mean age = 36.2 (range 18 – 62 years) N = 13 withdrew consent ARGENICA THERAPEUTICS N = 12 met criteria kept as • 53.1% female standbys • Single 10 minute IV • ARG-007 mean exposure: • Coho
Slide 9: Safety and tolerability of single escalating doses of ARG-007
Safety and tolerability of single escalating doses of SAEs or SUSARs: no serious, severe, life ARG-007 threatening or fatal TEAEs reported during the Safety was evaluated from the analysis of: study. 1) Incidence of SAEs and SUSARs 2) Clinically significant changes from Hematology: no dose-related
Slide 10: Safety and tolerability of single escalating doses of ARG-007
Safety and tolerability of single escalating doses of ARG-007 Safety was evaluated from the analysis of: 1) Incidence of SAEs and SUSARs 2) Clinically significant changes from baseline in laboratory evaluations of: ARGENICA THERAPEUTICS - Hematology - Clinical Chemistry ECG: no dose related trends
Slide 11: Safety and tolerability: related TEAEs
Safety and tolerability of single escalating doses of ARG-007 Safety was evaluated from the analysis of: Treatment Emergent 1) Incidence of SAEs and SUSARs AEs (TEAEs) 2) Clinically significant changes from baseline in laboratory evaluations of: ARGENICA THERAPEUTICS - Hematology - Clinical Chemis
Slide 12: Safety and tolerability: severity and type of TEAEs
Safety and tolerability of single escalating doses of ARG-007 Safety was evaluated from the analysis of: 1) Incidence of SAEs and SUSARs Severity of TEAEs 2) Clinically significant changes from baseline in laboratory evaluations of: ARGENICA THERAPEUTICS - Hematology - Clinical Chemistry - Coagula
Slide 13: Pharmacokinetic profile of ARG-007 following a single dose
Determine the pharmacokinetic profile of ARG-007 following a single dose • The highest concentration of ARG-007 in the plasma observed at the end of infusion (10 minutes). ARGENICA THERAPEUTICS • Concentrations of ARG-007 were detected in the bloodstream up to 48 hours after administration. • Half
Slide 14: Immune response of ARG-007 following a single dose
Assess the immune response of ARG-007 following a single dose Mean Percentage Change from Baseline 600 Treatment Group: 0.03 mg/kg ARG-007 (N=6) in INFγ Levels Over Time 0.10 mg/kg ARG-007 (N=6) 0.20 mg/kg ARG-007 (N=6) • The presence of cytokines (TNFα, INFγ, 0.30 mg/kg ARG-007 (N=6) 400 Pooled P
Slide 15: Doses of ARG-007 proved safe and well-tolerated
Phase 1 primary endpoint successfully achieved: DOSES OF ARG-007 PROVED SAFE & ARGENICA THERAPEUTICS WELL-TOLERATED, WITH NO SERIOUS ADVERSE EVENTS OR IMMUNE RESPONSE DETECTED. 14 www.argenica.com.au ASX Announcement titled ‘Interim Phase 1 safety report confirms safety of ARG-007’ 6 March 2023 ASX
Slide 16: Phase 2 study of ARG-007 in ischaemic stroke patients (SEANCON)
Phase 2 study of ARG-007 in Ischaemic Stroke Patients (“SEANCON”) ARGENICA THERAPEUTICS 15 www.argenica.com.au
Slide 17: Argenica Therapeutics
ARGENICA THERAPEUTICS 16 www.argenica.com.au