Aldeyra Therapeutics Reports Positive Results From Phase IIa Clinical Trial in Subjects With Allergic Conjunctivitis

NS2 Demonstrates Statistically Significant and Sustained Clinical Effects
Data Suggest Aldehyde Trapping as Novel Approach for the Treatment of Inflammatory Diseases
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LEXINGTON, Mass., Feb. 29, 2016  -- Aldeyra Therapeutics, Inc. (ALDX) (Aldeyra), a biotechnology company focused on the development of products to treat diseases related to aldehydes, today reported that the results of a randomized, parallel-group, single-center, double-masked, vehicle-controlled Phase IIa clinical trial of topical ocular NS2 in subjects with induced allergic conjunctivitis demonstrated statistically significant activity of NS2 over vehicle in reducing ocular itching and tearing.

Aldehydes are thought to be related to inflammatory conditions including allergic conjunctivitis, as well as other forms of ocular and non-ocular inflammation. NS2, a small molecule aldehyde trap, was tested in a conjunctival allergen provocation test (CAPT) model of allergic conjunctivitis.  One hundred healthy men and women with at least a two-year history of allergic conjunctivitis to grass, tree or ragweed pollen were enrolled and randomized in equal groups for treatment with topical ocular NS2 or vehicle.  The clinical endpoints in the trial included patient assessment (on a 0 to 4 point scale) of ocular itching and tearing, two prominent inflammation-related symptoms of allergic conjunctivitis.  

Statistically significant differences were demonstrated for ocular itching (p<0.05) and ocular tearing (p<0.05) between NS2 and vehicle after single dose and multiple dose administration.  NS2 demonstrated durable effects throughout the three hours following CAPT challenge.  The effects of NS2 persisted across substantially all time points for all CAPT challenges despite a stronger than expected vehicle effect.  The reductions from baseline scores were of the same magnitude seen in the CAPT model with existing therapies utilized in the treatment of allergic conjunctivitis, and peak changes exceeded one point for both ocular itching and ocular tearing scores.

NS2 was generally well tolerated and there were no safety concerns during the trial. Transient and generally mild stinging was noted in the treatment arm.  Two patients dropped out of the trial during treatment.