Aldeyra Therapeutics, Inc. · NASDAQ:ALDX
Aldeyra Therapeutics — Technical Presentation (September 2018)
25 slides from Aldeyra Therapeutics's technical presentation, Sep 26, 2018
Slide 1: Reproxalap Phase 2b Dry Eye Disease Results
Reproxalap Phase 2b Dry Eye Disease Results September 2018 NASDAQ: ALDX ©Aldeyra Therapeutics, Inc. 2018 Exhibit 99.1
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: Under-served Patient Population
Under-served Patient Population Only 5% of diagnosed DED patients utilize current Rx treatments for dry eye disease Diagnosed but no Rx Rx Treated Patients Sources: “Dry Eyes” by R. M. Shtein, MD; www.uptodate.com, May 2018; Farrand et al; American Journal of Ophthalmology 90:98, 2017; Aldeyra prima
Slide 4: Positive Phase 2b Clinical Trial Results
Positive Phase 2b Clinical Trial Results Reproxalap: A Novel Drug Candidate For the Treatment of Dry Eye Disease Primary objective achieved: Endpoint selection and sample size powering confirmed for Phase 3 clinical trials Reproxalap demonstrated statistically significant improvements versus vehicle
Slide 5: Phase 2b Clinical Trial Design
Primary objective: Evaluate efficacy of reproxalap ophthalmic solutions vs. baseline and vehicle to confirm endpoint selection and sample size for Phase 3 clinical trials Inclusion/exclusion highlights: History of dry eye disease for at least 6 months Moderate to severe dry eye disease > 2 on OD & 4
Slide 6: Reproxalap's Broad Activity Across Dry Eye Symptoms and Signs
p values subject to change based on quality control analysis Source: Reproxalap DED Phase 2b clinical trial results ODS OSDI SANDE: Frequency Reproxalap’s Broad Activity Across Dry Eye Symptoms and Signs Consistent with Previous Clinical Trials Symptom Severity Measures OD&4S: Ocular Discomfort OD&4
Slide 7: Proposed Co-Primary Endpoint: Improved Ocular Dryness vs. Vehicle
Average Baseline Score = 3.1 Proposed Co-Primary Endpoint: Reproxalap Improved Ocular Dryness vs. Vehicle OD & 4-Symptom Questionnaire: Dryness (0-5) p values subject to change based on quality control analysis Source: Reproxalap DED Phase 2b clinical trial results ITT Population with Observed Data
Slide 8: Ocular Dryness Improvement in Higher Baseline Patients
Drug Potency Supported by Ocular Dryness Improvement vs. Vehicle in Higher Baseline Patients Mean Change from Baseline OD & 4-Symptom Questionnaire: Dryness (0-5) Total Population (N=100|100|100) ITT Population with Observed Data Only Above Median Baseline Population (N=79|69|69) ITT Population with
Slide 9: Ocular Discomfort Symptom Results
Average Baseline Score = 2.9 Ocular Discomfort Symptom Results Support Observed Improvement in Ocular Dryness Score OD & 4-Symptom Questionnaire: Overall Ocular Discomfort (0-5) ITT Population with Observed Data Only OD = Ocular Discomfort p values subject to change based on quality control analysis
Slide 10: Ocular Discomfort Improvement in Higher Baseline Patients
Drug Potency Supported by Ocular Discomfort Improvement vs. Vehicle in Higher Baseline Patients Mean Change from Baseline OD & 4-Symptom Questionnaire: Overall Ocular Discomfort (0-5) Total Population (N=100|100|100) ITT Population with Observed Data Only Above Median Baseline Population (N=69|65|64
Slide 11: Ocular Stinging Symptom Results
Average Baseline Score = 1.4 Ocular Stinging Symptom Results Support Observed Improvement in Ocular Dryness Score OD & 4-Symptom Questionnaire: Stinging (0-5) ITT Population with Observed Data Only OD = Ocular Discomfort p values subject to change based on quality control analysis Source: Reproxalap
Slide 12: Ocular Stinging Improvement in Higher Baseline Patients
Drug Potency Supported by Ocular Stinging Improvement vs. Vehicle in Higher Baseline Patients Mean Change from Baseline OD & 4-Symptom Questionnaire: Stinging (0-5) Total Population (N=100|100|100) ITT Population with Observed Data Only Above Median Baseline Population (N=66|56|67) ITT Population wi
Slide 13: Proposed Co-Primary Endpoint: Improved Ocular Staining vs. Vehicle
Average Baseline Score = 1.9 Proposed Co-Primary Endpoint: Reproxalap Improved Ocular Staining vs. Vehicle Fluorescein Staining: Nasal (0-4) ITT Population with Observed Data Only p values subject to change based on quality control analysis Source: Reproxalap DED Phase 2b clinical trial results 0.25
Slide 14: Ocular Staining Improvement in Higher Baseline Patients
Drug Potency Supported by Ocular Staining Improvement vs. Vehicle in Higher Baseline Patients Mean Change from Baseline Fluorescein Staining: Nasal (0-4) Total Population (N=100|100|100) ITT Population with Observed Data Only Above Median Baseline Population (N=59|56|62) ITT Population with Observed
Slide 15: Ocular Staining Responder Analyses
Ocular Staining Responder Analyses Demonstrate Statistical Superiority of Reproxalap over Vehicle p values subject to change based on quality control analysis Source: Reproxalap DED Phase 2b clinical trial results OD&4S = Ocular Discomfort & 4 Symptom Effect Size = Change from Baseline / Standard De
Slide 16: Broad Pattern of Drug Activity Across Symptoms and Signs
Dry Eye Disease Symptoms Broad Pattern of Drug Activity Across Dry Eye Disease Symptoms and Signs Supports Differentiated Product Profile Improvement Effect Size at Week 12 Dry Eye Disease Signs Improvement Effect size = Change from Baseline / Standard Deviation at Baseline Source: Reproxalap DED Ph
Slide 17: No Observed Safety Concerns and Generally Well Tolerated
Reproxalap: No Observed Safety Concerns and Generally Well Tolerated Consistent with prior topical reproxalap clinical experience in over 500 patients, no observed safety concerns, and predominantly mild instillation site irritation reported Rates consistent with recent Phase 2 dry eye disease clini
Slide 18: Reproxalap's Novel Mechanism of Action
Produces aqueous fluid Lacrimal gland Tear Film Produces mucin Conjunctiva Produces lipid Meibomian gland Mucin layer Aqueous layer Lipid layer Reproxalap’s Novel Mechanism of Action has the Potential to Address the Two Major Forms of Dry Eye Disease RASP = Reactive Aldehyde Species; Image adapted f
Slide 19: Positive Phase 2b Clinical Trial Results
Positive Phase 2b Clinical Trial Results Reproxalap: A Novel Drug Candidate For the Treatment of Dry Eye Disease Primary objective achieved: Endpoint selection and sample size powering confirmed for Phase 3 clinical trials Reproxalap demonstrated statistically significant improvements versus vehicle
Slide 20: Reproxalap Planned Phase 3 Program
Reproxalap Planned Phase 3 Dry Eye Disease Program Two Phase 3 clinical trials expected to be initiated in 2019, following discussion with regulatory authorities First Phase 3 clinical trial is an adaptive two-stage design; expected initiation in 2019 Stage 1: Protocol optimization and sample size c
Slide 21: Differentiated Product Profile Evidenced by Responder Analyses
Reproxalap’s Differentiated Product Profile Evidenced by Responder Analyses – Rapid and Symptom-Free (Ocular Dryness) p values subject to change based on quality control analysis Source: Reproxalap DED Phase 2b clinical trial results OD & 4-Symptom Questionnaire: Dryness ITT Population with Observed
Slide 22: A Unique Opportunity
A Unique Opportunity Early and consistent symptom improvements in Phase 2b clinical trial Patients & Physicians Not Satisfied Reproxalap: A Unique and Novel Product Candidate For Dry Eye Disease Sources: Aldeyra primary patient market research, primary physician market research, secondary market res
Slide 23: Anticipated Milestones
Anticipated Milestones* Anticipated Milestones* Dry Eye Disease Allergic Conjunctivitis Reproxalap: Late-Stage Development For Dry Eye Disease and Allergic Conjunctivitis – Two Medical Conditions with Significant Overlap Initiated reproxalap Phase 2b clinical trial in dry eye disease January 2018 Po
Slide 24: Deep and Innovative Pipeline
Deep and Innovative Pipeline Not Disclosed Reproxalap Ocular Reproxalap Dermal ADX-629 Systemic ADX-103 ADX-1612 Dry Eye Disease Allergic Conjunctivitis Noninfectious Anterior Uveitis Sjögren-Larsson Syndrome Autoimmune Disease Retinal Disease PTLD Phase 3 initiation 2019 Phase 3 results late 2018 /
Slide 25: Two Mechanisms of Action in Development
Two Mechanisms of action in development Seven Successful Phase 2 Clinical Trials 2016-2018 Phase 2 count includes mesothelioma investigator-sponsored trial; Phase 3 trials contingent on funding, regulatory review, and other factors. Four Phase 3 Clinical Trials Ongoing or Expected to Initiate
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