Achieve Life Sciences, Inc. · NASDAQ:ACHV
Achieve Life Sciences — Corporate Update (February 2018)
11 slides from Achieve Life Sciences's corporate update, Feb 20, 2018
Slide 1: Achieve Life Sciences - Committed to advancing cytisine as a smoking cessation aid
- Achieve Life Sciences - Committed to advancing cytisine as a smoking cessation aid to address the global tobacco addiction epidemic Exhibit 99.2
Slide 2: Forward Looking Statements
Forward Looking Statements This presentation contains forward-looking statements, including, but not limited to, statements regarding the timing of planned clinical development activities of cytisine; the projected path toward potential regulatory approval; the safety, efficacy and commercial potent
Slide 3: Phase I/II Repeat Dose PK/PD Preliminary Study Results February 2018
Phase I/II Repeat Dose PK/PD Preliminary Study Results February 2018
Slide 4: Cytisine Overview
Cytisine Overview Cytisine is a plant-based alkaloid with high affinity and specificity for neuronal nicotinic (α4β2) receptors. Established smoking cessation treatment that has been available in Central and Eastern Europe since the 1960’s; Estimated 20 million smokers have been treated with cytisin
Slide 5: Phase I/II Repeat Dose PK/PD Clinical Study of Cytisine
Objective: Evaluate PK profile and PD effect of 1.5mg and 3mg cytisine when administered as the standard 25-day schedule Population: Healthy, volunteer smokers (≥10 cigarettes/day and expired air CO > 11 ppm), and interested in smoking cessation (no quit date set or required) Phase I/II Repeat Dose
Slide 6: Cytisine Dosing Schedule
Cytisine Dosing Schedule 1.5 mg Standard Dose vs. 3 mg Dose Plasma samples to characterise Cmax Day 1 at first dose; Day 1, Day 2 & Day 3 at dose 6 Day 12 dose 5; Day 16 dose 4; Day 20 dose 3; Day 24 dose 2 Day 25 dose 1 Day 1-3: 6 tablets 9 mg 18 mg 2 hrs 2 hrs 2 hrs 2 hrs 2 hrs 2 hrs Day 4-12: 2½
Slide 7: Demographics
Demographics Characteristic 1.5 mg Cytisine (N=12) 3.0 mg Cytisine (N=12) Overall (N=24) Caucasian Other 12 (100%) 11(92%) 1 (8%) 23 (96%) 1 (4%) Female Male 4 (33%) 8 (67%) 5 (42%) 7 (58%) 9 (37%) 15 (63%) Age (yrs) Mean (SD) Median (Min, Max) 35.0 (9.4) 33.5 (20, 50) 38.8 (10.3) 38.0 (24, 59) 36.9
Slide 8: PK Profile: Predictable plasma concentration
Day 1 Day 2 Day 3 Day 12 Day 16 Day 20 Day 24 Day 25 Day 12 6x 5x 4x 3x 2x 1x PK Profile: Predictable plasma concentration
Slide 9: PK Results (Cmax)
PK Results (Cmax) Day1 Day 1 Day 2 Dose1 Dose6 Dose 6 Day 3 Dose 6 Day 12 Dose 5 Day 16 Dose 4 Day 20 Dose 3 WCytisine 1.5 mg mCytisine 3 mg Day24 Day 25 Dose2 Dose 1
Slide 10: Repeat Dose PK/PD Study Results: Significant Efficacy Signals Observed
Abstinence Rates (Biochemically verified) on Day 26 Cytisine 1.5 mg 50% (6/12) Cytisine 3 mg 67% (8/12) Overall 58% (14/24) Repeat Dose PK/PD Study Results: Significant Efficacy Signals Observed Average Cigarettes Smoked Per Day Note: Results from subjects in the age 18 to 65 cohort. The age >65 coh
Slide 11: Adverse Events and Conclusions
Preferred Term 1.5 mg Cytisine (N=12) 3.0 mg Cytisine (N=12) Overall (N=24) Any Headache Chest discomfort Nausea 8 (67%) 4 (33%) 0 0 9 (75%) 7 (58%) 2 (17%) 2 (17%) 17 (71%) 11 (46%) 2 (8%) 2 (8%) Conclusions PK & PD data confirm previously demonstrated cytisine effects Abstinence rate (biochemicall
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