Aldeyra Therapeutics, Inc. · NASDAQ:ALDX
Aldeyra Therapeutics — Technical Presentation (December 2023)
19 slides from Aldeyra Therapeutics's technical presentation, Dec 19, 2023
Slide 1: Top-Line Results from the Phase 2 Clinical Trial of ADX-629 in Atopic Dermatitis
Top-Line Results from thePhase 2 Clinical Trial of ADX-629in Atopic Dermatitis DATA RELEASE December 19, 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: RASP are Toxic, and Represent a Novel, Potentially Broadly Applicable Pharmaceutical Target
RASP are Toxic, and Represent a Novel, Potentially Broadly Applicable Pharmaceutical Target RASP = reactive aldehyde species Drugs Metabolism & Lipid Peroxidation Smoking & Vaping Food & Beverages Pollution Endogenous aldehyde sourced within the body Inflammation Exogenous aldehyde sourced outside t
Slide 4: RASP Modulation Represents a Novel Pharmacology
RASP Modulation Represents a Novel Pharmacology RASP = reactive aldehyde species Traditional pharmacology targets specific proteins and is generally limited to two actions: on or off. . Activating or inhibiting specific proteins on a sustained basis, which rarely occurs in nature, may lead to toxici
Slide 5: ADX-629, a First-in-Class Orally Administered 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. CI = confidence interval. LOCF = last observation carried forward. NIAID = National Institute of Allergy and Infectious Diseases. RASP = re
Slide 6: ADX-629 Data Suggest Potential for Next-Generation Investigational RASP Modulators ADX-246 and ADX-248
ADX-629 Data Suggest Potential for Next-Generation Investigational RASP Modulators ADX-246 and ADX-248 ADX-246 Oral Administration … designed to treat immune-mediated systemic diseases thought to be caused or exacerbated by pro-inflammatory RASP. Pre-clinical studies of ADX-246 demonstrated high aff
Slide 7: Current Treatment Options for Patients with Mild to Moderate Atopic Dermatitis are Often Sub-Optimal
Current Treatment Options for Patients with Mild to Moderate Atopic Dermatitis are Often Sub-Optimal Atopic dermatitis is a common skin disease associated with itching and dermal lesions, occurring in children and adults. The etiology of atopic dermatitis is generally thought to be caused by immune
Slide 8: ADX-629: Phase 2 Clinical Trial Design in Atopic Dermatitis
ADX-629: Phase 2 Clinical Trial Design in Atopic Dermatitis Primary Endpoint Treatment-emergent adverse events and serious adverse events Secondary Efficacy Endpoints Investigator global assessment (IGA) Eczema Area and Severity Index (EASI) Time to flare (i.e., rescue therapy required) Patient-Orie
Slide 9: Baseline Characteristics Enrolled Population (N=8)
Baseline Characteristics Enrolled Population (N=8) Mean (SD) Age 39.9 (14.7) Atopic dermatitis history (years) 10.9 (8.7) IGA 3.0 (0.9) EASI 6.0 (3.7) POEM 18.9 (4.1) Peak itching score 7.1 (1.7) ADX-629 is an investigational drug candidate. IGA = investigator global assessment. EASI = eczema area a
Slide 10: ADX-629 Was Observed to be Well Tolerated and No Safety Signals Were Identified
ADX-629 Was Observed to be Well Tolerated and No Safety Signals Were Identified ADX-629 is an investigational drug candidate. Treatment-related adverse events are treatment-emergent adverse events at least possibly related to drug. Safety Population (N=8) Number (%) of Subjects with Treatment-Relate
Slide 11: Statistically and Clinically Significant Improvement in EASI Score Observed with ADX-629
Statistically and Clinically Significant Improvement in EASI Score was Observed during Treatment with ADX-629 ADX-629 is an investigational drug candidate. EASI = eczema area and severity index (investigator-assessed). SEM = standard error of measurement. EASI-50 = 50% EASI-75 = 38% EASI-90 = 13%
Slide 12: Significant Improvement in Affected Body Surface Area Observed with ADX-629
Statistically and Clinically Significant Improvement in Affected Body Surface Area was Observed during Treatment with ADX-629 ADX-629 is an investigational drug candidate. Affected body surface area was investigator-assessed. SEM = standard error of measurement. Complete clearance = 13%
Slide 13: Significant Improvement in IGA Observed with ADX-629
Statistically and Clinically Significant Improvement in IGA was Observed during Treatment with ADX-629 ADX-629 is an investigational drug candidate. IGA = investigator global assessment; IGA of 0 is clear and IGA of 1 is almost clear. SEM = standard error of measurement. IGA of 0 or 1 = 13%
Slide 14: Significant Improvement in Peak Itching Score Observed with ADX-629
Statistically and Clinically Significant Improvement in Peak Itching Score was Observed during Treatment with ADX-629 ADX-629 is an investigational drug candidate. Patient-reported peak itching score was assessed by the Peak Pruritus Numerical Rating Scale. SEM = standard error of measurement. ≥4-po
Slide 15: Significant Improvement in POEM Observed with ADX-629
Statistically and Clinically Significant Improvement in POEM was Observed during Treatment with ADX-629 ADX-629 is an investigational drug candidate. POEM = patient-oriented eczema measure (patient-reported). SEM = standard error of measurement. ≥4-point reduction clinical relevance threshold = 75%
Slide 16: Improvement in Assessments of Depression and Anxiety Observed with ADX-629
Improvement in Assessments of Depression and Anxiety was Observed during Treatment with ADX-629 ADX-629 is an investigational drug candidate. SEM = standard error of measurement. †Allergy. 73(1): 214-220, 2018. Atopic dermatitis is associated with anxiety, depression, and suicidal ideation.†
Slide 17: Activity of ADX-629 in Atopic Dermatitis Consistent with Activity in Psoriasis
The Observed Activity of ADX-629 in Atopic Dermatitis is Consistent with the Observed Activity of ADX-629 in Psoriasis ADX-629 is an investigational drug candidate. SEM = standard error of measurement. Atopic Dermatitis Psoriasis EASI PASI IGA IGA
Slide 18: ADX-629 Demonstrated Broad Investigator-Assessed and Patient-Reported Activity in Atopic Dermatitis
ADX-629 Demonstrated Broad Investigator-Assessed andPatient-Reported Activity in Atopic Dermatitis Statistically significant improvement from baseline observed in investigator-assessed Eczema Area and Severity Index (EASI, p=0.0006) and Investigator Global Assessment (IGA, p<0.0001) EASI 75% improve
Slide 19: Atopic Dermatitis is the First of Aldeyra's RASP Programs to Advance to Formal Development with ADX-246
Atopic Dermatitis is the First of Aldeyra’s RASP Programs to Advance to Formal Development with ADX-246 Given the positive signal-finding results from ADX-629, ADX-246, which we believe is the most potent RASP modulator ever developed, is expected to be advanced to clinical testing in Phase 1/2 clin
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