Thx Pharma · EURONEXT:ALTHX
Thx Pharma — Theranexus — Technical Presentation (January 2020)
9 slides from Thx Pharma's technical presentation, Jan 15, 2020
Slide 1: Study THN201-101 Key Results
Study THN201-101 Key Results A Pharmacodynamics, Safety, and Pharmacokinetics Study of THN201 Versus Donepezil in Healthy Male Volunteers ClinicalTrials.gov : NCT03698695 January 15th, 2020 1
Slide 2: THN201-101: Study Design
THN201-101 : STUDY DESIGN A PHARMACODYNAMICS, SAFETY, AND PHARMACOKINETICS STUDY OF THN201 VERSUS DONEPEZIL (DPZ) IN HEALTHY MALE SUBJECTS A DOUBLE-BLIND, RANDOMIZED, PARALLEL-GROUP, PLACEBO & ACTIVE CONTROLLED STUDY (10 SITES IN EUROPE - PI: PROF. REGIS BORDET, LILLE) D1 D15 D29 PBO PBO N=30 N=152
Slide 3: THN201-101: Key Results - Demographics
THN201-101 : KEY RESULTS DEMOGRAPHICS • 152 healthy male subjects randomized (62 THN; 60 DPZ; 30 Placebo) • 147 subjects completed the study (60 THN201 ; 58 DPZ ; 29 Placebo) • Small number of drop-outs : 5 drop-outs (2 THN201 ; 2 DPZ ; 1 Placebo) • THN201 : 1 discontinuation for adverse event, 1 di
Slide 4: Conclusion: Speed of Memory
THN201-101 : KEY RESULTS SPEED OF MEMORY • « Speed of memory » is a composite endpoint of the CDR assessment ; this endpoint is typically considered to be one of the most sensitive to decline in AD patients over time (Wesnes et al, 2010). CONCLUSION : • Significant increase of speed of memory by THN
Slide 5: Conclusion: EEG Power in the Gamma Band
THN201-101 : KEY RESULTS EEG POWER IN THE GAMMA BAND • EEG power has been quantified during scopolamine challenge and the gamma band (30-40 Hz) has been extracted. • EEG gamma band is recognized as a marker of cognitive activity (Herrmann et al, 2001 ; Fitzgibbon et al, 2004) ; an increase in this b
Slide 6: Attention: Simple Reaction Time
THN201-101 : KEY RESULTS ATTENTION: SIMPLE REACTION TIME • Simple Reaction Time is a task used to quantify Attention. CONCLUSION : • Significant improvement of Simple Reaction Time by THN201 (p=0.03) and DPZ (p=0.04) vs Placebo at 1 h post scopolamine challenge 6
Slide 7: Event Related Potentials (P300)
THN201-101 : KEY RESULTS EVENT RELATED POTENTIALS (P300) • The P300 (P3) wave is an event-related potential (ERP) component linked to attentional processes and decision making. • P300 is altered during scopolamine challenge. CONCLUSION : • P300 is strongly impaired 1 hr after scopolamine challenge •
Slide 8: Safety and Tolerability
THN201-101 : KEY RESULTS SAFETY AND TOLERABILITY • Adverse events (attributed to treatment): • THN201 : Nausea , headache, fatigue, insomnia • DPZ : Nausea , headache, GI symptoms, insomnia, irritability • Placebo : Headache, fatigue, irritability CONCLUSION : • Overall THN201 very well tolerated. •
Slide 9: Conclusions
THN201-101 : KEY RESULTS CONCLUSIONS • Pharmacological profile of THN201 • Stronger mnemonic fluidity observed during cognitive tests (CDR Speed of Memory) compared to Donepezil alone • Stronger activity in the Gamma band of EEG which is involved in cognitive processes compared to Donepezil alone •