Aldeyra Therapeutics, Inc. · NASDAQ:ALDX
Aldeyra Therapeutics — Technical Presentation (June 2023)
18 slides from Aldeyra Therapeutics's technical presentation, Jun 29, 2023
Slide 1: Top-Line Results from the Phase 2 Clinical Trial of ADX-2191 in Retinitis Pigmentosa
Top-Line Results from thePhase 2 Clinical Trial of ADX-2191 in Retinitis Pigmentosa DATA RELEASE June 29, 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: ADX-2191 Demonstrated Activity and Was Well Tolerated in Retinitis Pigmentosa Phase 2 Clinical Trial
ADX-2191 (methotrexate injection, USP) for intravitreal administration is an investigational drug candidate. ADX-2191 Demonstrated Activity and Was Well Tolerated in Retinitis Pigmentosa Phase 2 Clinical Trial Best-corrected and low-light visual acuity statistically significantly improved. As assess
Slide 4: ADX-2191, an Investigational Vitreous-Compatible Formulation of Methotrexate, Represents a Platform Approach
ADX-2191, an Investigational Vitreous-Compatible Formulation of Methotrexate, Represents a Platform Approach for Rare Retinal Diseases ADX-2191 (methotrexate injection, USP) is the first sterile, non-compounded formulation of methotrexate designed to meet the unique requirements of intravitreal admi
Slide 5: In the Phase 3 GUARD Trial of ADX-2191 in PVR, the Primary Endpoint Was Achieved
ADX-2191 (n=68) Historical Control† (n=292) Patients with retinal detachment within 6 months of surgery 16 113 Odds ratio (95% CI) vs. historical control 0.49 (0.26, 0.89) P value vs. historical control* 0.024 In the Phase 3 GUARD Trial of ADX-2191 in Proliferative Vitreoretinopathy, the Primary End
Slide 6: ADX-2191 Was Numerically Favored Over Routine Surgical Care for Key Safety Endpoints in the GUARD Trial
All treatment-emergent adverse events affecting at least 10% of patients in either treatment group ADX-2191 Was Numerically Favored Over Routine Surgical Care for Key Safety Endpoints in the GUARD Trial ADX-2191 (methotrexate injection, USP) for intravitreal administration is an investigational drug
Slide 7: ADX-2191 Has the Potential to be the First Approved Drug for Retinitis Pigmentosa
ADX-2191 Has the Potential to be the First Approved Drug for Retinitis Pigmentosa, a Clinical Group of Rare Genetic Eye Diseases Retinitis pigmentosa refers to a group of inherited retinal diseases characterized by cell death and loss of vision. Retinitis pigmentosa affects more than 1 million peopl
Slide 8: Illustrative Retinal Images from an Enrolled Patient in the Phase 2 Retinitis Pigmentosa Trial
Illustrative Retinal Images from an Enrolled Patient in the Phase 2 Retinitis Pigmentosa Trial Color Fundus Photograph Autofluorescence Photograph ADX-2191 (methotrexate injection, USP) for intravitreal administration is an investigational drug candidate.
Slide 9: Simulated Vision of Patients with Advanced Retinitis Pigmentosa
Simulated Vision of Patients with Advanced Retinitis Pigmentosa Angelopoulos, A. (2019). Enhanced Depth Navigation Through Augmented Reality Depth Mapping in Patients with Low Vision. Scientific Reports. Unaffected Individual Advanced Retinitis Pigmentosa
Slide 10: ADX-2191: Phase 2 Design in Retinitis Pigmentosa
ADX-2191: Phase 2 Clinical Trial Design in Retinitis Pigmentosa Primary Endpoint Safety and tolerability Secondary Endpoints Best corrected and low-light visual acuity Macular retinal sensitivity as assessed by MAIA perimetry Dark-adapted flash analyzed by ERG Peripheral retinal sensitivity as asses
Slide 11: Baseline Characteristics Were Similar Across Groups
Baseline Characteristics Were Similar Across Groups ADX-2191 (methotrexate injection, USP) for intravitreal administration is an investigational drug candidate. Visual acuity is best corrected visual acuity. 78 letters represents approximately 20/30 vision, and 84 letters represents approximately 20
Slide 12: ADX-2191 Was Well Tolerated and No Safety Signals Were Observed
ADX-2191 Was Well Tolerated and No Safety Signals Were Observed ADX-2191 (methotrexate injection, USP) for intravitreal administration is an investigational drug candidate. Events reflect treatment-related adverse events deemed at least possibly related to drug. MONTHLY COHORT TWICE-MONTHLY COHORT S
Slide 13: Statistically Significant Improvement in Visual Acuity Observed in the Retinitis Pigmentosa Phase 2 Trial
Statistically Significant Improvement in Visual Acuity Observed in the Retinitis Pigmentosa Phase 2 Clinical Trial ADX-2191 (methotrexate injection, USP) for intravitreal administration is an investigational drug candidate. Baseline best corrected visual acuity for the twice-monthly dosing cohort wa
Slide 14: Visual Acuity in ADX-2191-Treated Eyes Was Superior to that of Untreated Eyes
In the Retinitis Pigmentosa Phase 2 Clinical Trial, Visual Acuity inADX-2191-Treated Eyes Was Superior to that of Untreated Eyes Normal Lighting Dim Lighting Treatment Period Treatment Period ADX-2191 (methotrexate injection, USP) for intravitreal administration is an investigational drug candidate.
Slide 15: As Assessed by ERG, Retinal Function Improved in the Retinitis Pigmentosa Phase 2 Trial
As Assessed by ERG, Retinal Function Improved in the Retinitis Pigmentosa Phase 2 Clinical Trial ADX-2191 (methotrexate injection, USP) for intravitreal administration is an investigational drug candidate. B-wave response and implicit time following dim flash under scotopic conditions were assessed.
Slide 16: As Assessed by MAIA Microperimetry, Statistically Significant Improvement in Retinal Sensitivity Observed
As Assessed by MAIA Microperimetry, Statistically Significant Improvement in Retinal Sensitivity Observed in the Retinitis Pigmentosa Phase 2 Clinical Trial ADX-2191 (methotrexate injection, USP) for intravitreal administration is an investigational drug candidate. Baseline retinal sensitivity was a
Slide 17: As Assessed by DAC Perimetry, Statistically Significant Improvement in Retinal Sensitivity Observed
As Assessed by DAC Perimetry, Statistically Significant Improvement in Retinal Sensitivty Observed in the Retinitis Pigmentosa Phase 2 Clinical Trial ADX-2191 (methotrexate injection, USP) for intravitreal administration is an investigational drug candidate. Data derived from mixed model for repeate
Slide 18: Upcoming Planned Clinical Milestones
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
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