Aldeyra Therapeutics has reported positive results from a phase 2a clinical trial of topical ocular NS2 used to treat allergic conjunctivitis. The drug demonstrated statistically significant and sustained clinical effects, such as reduction of ocular itching and tearing.
The randomized, parallel-group, single-center, double-masked, vehicle-controlled trial of topical ocular NS2 was conducted in 100 healthy men and women with at least a two-year history of allergic conjunctivitis to grass, tree, or ragweed pollen. The subjects, who were induced with allergic conjunctivitis for the study, were randomized in equal groups for treatment with NS2 or vehicle. The clinical endpoints included patient assessment of ocular itching and tearing, two prominent inflammation-related symptoms of allergic conjunctivitis.
There were no safety concerns during the trial, and NS2 was well tolerated. After single-dose and multiple-dose administration, statistically significant differences were demonstrated for ocular itching and ocular tearing between NS2 and vehicle.
Aldehydes—toxic and proinflammatory mediators of many diseases—are thought to be related to inflammatory conditions such as allergic conjunctivitis. NS2 is an aldehyde-binding small molecule that “traps” aldehydes, thus reducing the load of aldehydes in the body. This may lessen excessive inflammation and be applicable to diseases where aldehyde metabolism is impaired.
NS2 is also being studied in patients with noninfectious anterior uveitis and Sjögren-Larsson syndrome.
“To our knowledge, the data from this clinical trial represent the first example of clinical efficacy of an aldehyde trap in human disease,” said Todd C. Brady, MD, PhD, President and CEO of Aldeyra. “We are thrilled with the outcome of this trial and believe that the results suggest important insight into the physiology of inflammation and further applicability of aldehyde trapping in the treatment of inflammatory disease.”
Source: Aldeyra Therapeutics; February 29, 2016.