Slide 1: Efficacy and Safety of CTx-1301 in Pediatric Subjects With ADHD: Phase 3 Results
Efficacy and Safety of CTx-1301 in Pediatric Subjects With ADHD: Results From a Phase 3, Randomized, Double-Blind, Placebo-Controlled Trial s Ann Catherine Childress, MD, 1 Matthew Brams, MD,2 Raul Silva, MD, 3 and Kelly Koehn, MS4 1Center for Psychiatry and Behavioral Medicine, Inc., Las Vegas, NV,
Slide 2: Disclosure
Disclosure Ann Catherine Childress, MD Potential conflict of interest with the following business, organization and individual Name of business, organization or Nature of conflict individual Aadrvark, Attentive, and Sky Consultant Allergan, Adlon, Lilly, Sanofi, Suven, and Syndeio Research Support A
Slide 3: Background and Objectives
Background and Objectives • Inadequately managed ADHD contributes to significant health, social, and economic burden in children and adolescents1 • Many patients treated with long-acting stimulants experience inadequate symptom control during the day2 • Strategies to improve onset and duration of tr
Slide 4: Study Design and Endpoints
Study Design and Endpoints Phase 3, double-blind, randomized, placebo-controlled, fixed-dose, N=103 parallel-group study in patients aged 6–17 years with confirmed ADHD Screening Double-blind treatment period Follow-up 37.5 mg 25 mg 18.75 mg 12.5 mg Primary endpoint: CTx-1301 (n=77) • Change in ADHD
Slide 5: Patients
Patients Key exclusion Key inclusion criteria • Patients aged 6 to 17 years • Any psychiatric diagnosis of bipolar I or II, major • Confirmed ADHD by DSM-5 criteria or any of the three depressive, conduct, disruptive mood dysregulation, presentations (combined, inattentive, or intellectual disabilit
Slide 6: Demographics and Baseline Characteristics Were Generally Similar Among Treatment Groups
Demographics and Baseline Characteristics Were Generally Similar Among Treatment Groups Characteristics Placebo CTx-1301 (n = 26) 18.75 mg (n = 26) 25 mg (n = 26) 37.5 mg (n = 25) Age, mean ± SD, years 11.5 ± 3.3 11.4 ± 3.6 11.3 ± 3.2 11.0 ± 3.2 Male sex, n (%) 17 (65.4) 13 (50.0) 16 (61.5) 16 (64.0
Slide 7: CTx-1301 Significantly Improved ADHD-RS-5 Score Compared With Placebo
CTx-1301 Significantly Improved ADHD-RS-5 Score Compared With Placebo Primary Endpoint ADHD-RS-5 score* at week 5 CTx-1301 Placebo (n = 22) 18.75 mg (n = 21) 25 mg (n = 22) 37.5 mg (n = 20) 0 -8.26 -17.07 -17.60 -22.42 ADHD-RS-5 change -5 from baseline (ML -10 estimate) -15 -20 LS mean difference (9
Slide 8: CTx-1301 Improved CGI-S and CGI-I Scores Compared to Placebo
CTx-1301 Improved CGI-S and Greater Proportion of Patients Demonstrated Improvement Based on CGI-I Scores Compared to Placebo Secondary outcomes CGI-S score CGI-I score* CTx-1301 100 4.5 Placebo (n = 22) 18.75 mg (n = 21) 25 mg (n = 22) 37.5 mg (n = 20) 18.1% 13.6 23.8 23.8 0.0 improved 31.6 -0.73 -
Slide 9: Safety Profile
Safety Profile Category Placebo CTx-1301 18.75 mg 25 mg 37.5 mg (n = 26) (n = 26) (n = 26) (n = 25) Any TEAE, n (%) 10 (38.5) 13 (50.0) 9 (34.6) 17 (68.0) • CTx-1301 demonstrated Mild 5 (19.2) 11 (42.3) 5 (19.2) 11 (44.0) a favorable safety Moderate 5 (19.2) 2 (7.7) 4 (15.4) 6 (24.0) profile, with n
Slide 10: Summary
Summary CTx-1301 demonstrated consistent dose-dependent efficacy in improving ADHD symptoms in children and adolescents The 37.5-mg dose demonstrated the largest effect size and symptom reduction; effect sizes were substantial considering the fixed-dose study design CTx-1301 showed favorable safety