Aldeyra Therapeutics, Inc. · NASDAQ:ALDX
Aldeyra Therapeutics — Corporate Update (May 2016)
17 slides from Aldeyra Therapeutics's corporate update, May 9, 2016
Slide 1: Noninfectious Anterior Uveitis Phase II Results and Ocular Clinical Development Update
Noninfectious Anterior Uveitis Phase II Results and Ocular Clinical Development Update May 9, 2016 Exhibit 99.2
Slide 2: Disclaimers and Forward-Looking Statements
Disclaimers and Forward-Looking Statements This presentation contains forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, including statements regarding Aldeyra’s possible or assumed future results of operations and expenses, business stra
Slide 3: Aldehydes Are Mediators of Inflammation
Aldehydes Are Mediators of Inflammation NS2 is a first-in-class aldehyde trap and is the lead compound in a novel anti-inflammatory platform. Aldehydes Protein Signaling via Thiol and Amine Binding Inflammasome , NF-KB Activation Cytokine Release
Slide 4: The Aldehyde Trap Ocular Anti-Inflammatory Platform
The Aldehyde Trap Ocular Anti-Inflammatory Platform ü ü NS2 has demonstrated activity in the two major types of inflammation, and has the potential to be efficacious in a wide variety of inflammatory disease. Allergy (TH2 Cytokines) Atopic Kerato -Conjunctivitis, etc. Allergic Conjunctivitis Autoimm
Slide 5: Trapping Aldehydes Generates a Broad Anti-Inflammatory Response
Trapping Aldehydes Generates a Broad Anti-Inflammatory Response In a murine model of cytokine storm, NS2 administration significantly reduced levels of pro-inflammatory cytokines while up-regulating an anti-inflammatory cytokine. Mice treated with NS2 or vehicle prior to endotoxin exposure; cytokine
Slide 6: Topical NS2 Decreases Ocular Inflammation in an Animal Model
Topical NS2 Decreases Ocular Inflammation in an Animal Model pg/mg tissue * *p<0.05 ****p<0.00001 Rat LPS-Induced Ocular Inflammation at 24 Hours Post-Stimulus, NS2 dosed topically QID Topically administered NS2 has clinically significant effects in a widely used animal model of ocular inflammation
Slide 7: Phase II Clinical Trial Design for Allergic Conjunctivitis
Phase II Clinical Trial Design for Allergic Conjunctivitis Dosing Control Enrollment Treatment Time Endpoints Further information can be found on www.clinicaltrials.gov: Trial #NCT02578914. Allergen Challenges 1 Dosing Day 14 15 16 Allergic Conjunctivitis NS2 Topical Ocular QID Vehicle 1:1, Double-M
Slide 8: Clinically Meaningful Effects Observed in Allergic Conjunctivitis Phase II (Day 1)
Clinically Meaningful Effects Observed in Allergic Conjunctivitis Phase II NS2 achieved reductions in ocular itching and tearing that were clinically relevant and statistically greater than vehicle. Change in Score from Baseline Ocular Itching Ocular Tearing Vehicle NS2 Dosing Day 1 (First Dose) Min
Slide 9: Clinically Meaningful Effects Observed in Allergic Conjunctivitis Phase II (Day 14)
Clinically Meaningful Effects Observed in Allergic Conjunctivitis Phase II NS2 achieved reductions in ocular itching and tearing that were clinically relevant and statistically greater than vehicle. Change in Score from Baseline Ocular Itching Ocular Tearing Vehicle NS2 Dosing Day 14 Minutes Post-Ch
Slide 10: Noninfectious Anterior Uveitis: A Serious Inflammatory Disease
Noninfectious Anterior Uveitis: A Serious Inflammatory Disease Aldeyra’s lead aldehyde trap reduced anterior chamber cell count in a manner comparable to corticosteroids in a Phase II clinical trial Q2 2016. Uveitis Acute anterior ocular inflammation Inflammatory cells in front of eye, pain , photop
Slide 11: Clinical Design
Noninfectious Anterior Uveitis Phase II Clinical Design Dosing NS2 0.5% Topical Ocular Pred Forte® 1% Topical Ocular Randomization Active-Controlled 1:1:1 NS2 QID, Pred Forte® QID Taper, NS2 QID + Pred Forte® BID Taper Enrollment 45 Patients with Active Disease Treatment Time 6 Weeks Endpoints Cell
Slide 12: NS2 Comparable to Corticosteroid in Anterior Uveitis
NS2 (n=15) Pred Forte (n=13) NS2 + Pred Forte (n=16) Week 2 Cell Grade 0 5 (33%) 4 (31%) 5 (31%) Week 8 Cell Grade 0 6 (40%) 6 (46%) 7 (44%) ≥ 1 Cell Grade Reduction 8 (53%) 6 (46%) 8 (50%) Rescue Medication Required 3 (20%) 5 (38%) 4 (25%) NS2 Comparable to Corticosteroid in Noninfectious Anterior
Slide 13: NS2 Comparable to Corticosteroid: Change in Anterior Chamber Cell Count
NS2 Comparable to Corticosteroid in Noninfectious Anterior Uveitis Phase II Mean (+/-SD) Change from Baseline in Anterior Chamber Cell Count over Time (mITT Population*, Last Observation Carried Forward) *Modified intent-to-treat population excludes one patient that was found to have history of ovar
Slide 14: NS2 Comparable to Corticosteroid: No Statistically Significant Differences
No statistically significant differences* for anterior chamber cell count or flare were observed between groups in: Time to sustained grade of 0 Proportion of subjects with sustained grade 0 Time to sustained reduction of 1-point or greater grade Proportion of subjects with sustained 1-point or grea
Slide 15: NS2 Generally Well-Tolerated in Uveitis
No significant differences observed in symptom scores No SAEs in any group Eye stinging/burning was reported in the NS2 treated groups 4 subjects in NS2 group, leading to one discontinuation 3 subjects in NS2+Corticosteroid group, leading to one discontinuation Overall, NS2 was well tolerated with n
Slide 16: Clinical/Regulatory Development Plans for Topical Ocular NS2
Clinical/Regulatory Development Plans for Topical Ocular NS2 Allergic Conjunctivitis Pre-IND Meeting and IND Filing (prior Phase II was under CTA) Phase II/III Dose-Ranging Noninfectious Anterior Uveitis Regulatory Advice Meeting Phase II/III Dose-Ranging Other ocular inflammation Phase II trials un
Slide 17: Potential Markets for NS2 in Ocular Inflammation
Potential Markets for NS2 in Ocular Inflammation VKC AKC Topical Corticosteroid Use In Ophthalmology Dry Eye/MGD Allergic Conjunctivitis Refractive Surgery Post-Cataract Ocular Rosacea Blepharitis Iritis Cyclitis Corneal Trauma Ocular GVHD Persistent Corneal Erosion Uveitis Scleritis Corneal Transpl