Slide 1: Top-Line Results from the Phase 2 Clinical Trial of ADX-629 in Chronic Cough
Top-Line Results from thePhase 2 Clinical Trial ofADX-629 in Chronic Cough DATA RELEASE June 27, 2023 Nasdaq: ALDX © Aldeyra Therapeutics, Inc. 2023
Slide 2: Disclaimers and Forward-Looking Statements
Disclaimers and Forward-Looking Statements This presentation and various remarks which may be made during this presentation contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and Section 21E of the Securities Exchange Act of 1934, as amended
Slide 3: Phase 2 Trial of ADX-629 in Chronic Cough Demonstrated Significant Reduction in Cough Frequency vs. Placebo
The Phase 2 Clinical Trial of ADX-629 in Chronic Cough Demonstrated Statistically Significant Reduction in Cough Frequency vs. Placebo The primary endpoint of safety was met:ADX-629 was well tolerated with no identified safety concerns. Statistical significance was achieved for all assessed continuo
Slide 4: ADX-629, a First-in-Class Oral RASP Modulator, Has Demonstrated Activity in Phase 2 Clinical Trials
ADX-629, a First-in-Class Orally Administered RASP Modulator, Has Demonstrated Activity in Phase 2 Clinical Trials ADX-629 is an investigational drug candidate. P values are derived from mixed model for repeated measures analysis of placebo group comparison to 0 (no change). SEM = standard error of
Slide 5: Phase 2 Crossover Trial Design in Adults with Chronic Cough
SCREENING RANDOMIZATION TREATMENT PERIOD 1 WASHOUT TREATMENT PERIOD 2 FOLLOW-UP A Phase 2, Multicenter, Randomized-Sequence, Double-Blind, Placebo-Controlled, Crossover Clinical Trial to Evaluate the Safety and Efficacy of ADX-629 in Adults with Chronic Cough Up to 21 Days 14 Days 14 Days 14 Days Sc
Slide 6: Baseline Characteristics Were Similar Across Sequences
ADX-629 to Placebo (n=26) Mean (SD) or % Placebo to ADX-629 (n=25) Mean (SD) or % Mean Age (years) 65.3 (9.5) 65.2 (7.1) BMI (kg/m2 ) 29.4 (9.5) 28.4 (4.7) Gender Male (19%), Female (81%) Male (16%), Female (84%) Awake Cough Frequency 51.8 (44.4) 44.7 (32.4) Chronic Cough History (years) 18.8 (15.7)
Slide 7: ADX-629 Was Well Tolerated and No Safety Signals Were Identified
ADX-629 Was Well Tolerated and No Safety Signals Were Identified ADX-629 is an investigational drug candidate. Severity summary reflects treatment-emergent adverse events. Placebo (n=51) ADX-629 (n=51) Serious Adverse Events 0 0 Severe 0 0 Moderate 2 (3.9%) 4 (7.8%) Mild 8 (15.7%) 10 (19.6%) Caused
Slide 8: ADX-629 Achieved the Key Secondary Endpoint of Reduction in Awake Cough Frequency
ADX-629 Achieved the Key Secondary Endpoint of Reduction inAwake Cough Frequency in the Phase 2 Chronic Cough Clinical Trial Key secondary endpoint of awake cough frequency reduction achieved Reduction of awake cough frequency (coughs per hour) following ADX-629 treatment statistically significantly
Slide 9: ADX-629 Achieved the Secondary Endpoint of Reduction in 24-Hour Cough Frequency
ADX-629 Achieved the Secondary Endpoint of Reduction in24-Hour Cough Frequency in the Phase 2 Chronic Cough Clinical Trial Secondary endpoint of 24-hour cough frequency reduction achieved Reduction of 24-hour cough frequency (coughs per hour) following ADX-629 treatment statistically significantly s
Slide 10: Lipid Profiles Improved Following ADX-629 Treatment in the Chronic Cough Trial
Lipid Profiles Improved Following ADX-629 Treatment in the Phase 2 Chronic Cough Clinical Trial LS means and P values derived from mixed effect model of repeated measures analysis that adjusted for baseline and prior treatment to account for carryover effect. ADX-629 is an investigational drug candi
Slide 11: Lipid Profiles Improved Following ADX-629 Treatment in Previous Psoriasis Trials
Lipid Profiles Improved Following ADX-629 Treatment in Previously Completed Phase 1 and Phase 2 Psoriasis Clinical Trials P values derived from mixed effect model of repeated measures analysis that adjusted for baseline. Phase 1 results derived from assessments following ingestion of a fatty meal. A
Slide 12: Upcoming Planned Clinical Milestones
†Regulatory review timelines are flexible and subject to change based on the regulator's workload and other potential review issues. ‡The timing of ongoing clinical trials depends, in part, on the availability of clinical research facilities and staffing, and the ability to recruit patients. *Invest