Aldeyra Stumbles Over Mid-Stage Clinical Results

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Aldeyra Therapeutics Inc. (NASDAQ: ALDX) saw its shares slide on Wednesday after the company gave an update from its mid-stage trial of topical ocular ADX-102 in patients with allergic conjunctivitis. Unfortunately, the company said its allergic conjunctivitis drug missed the primary endpoint in this Phase 2b trial.

Despite this setback, Aldeyra plans to initiate Phase 3 clinical testing with ADX-102 following discussion with the regulatory authorities in the second half of this year.

Overall, the observed percentage improvements in the itch score for 0.5% ADX-102 versus vehicle were 23%, 37%, 55% and 65% at 10, 20, 30 and 60 minutes, respectively, post-challenge in seasonal allergy patients. The data suggest that the 38% one-point equivalent threshold was met or exceeded 20 minutes post-challenge and later.

Also, 0.1% ADX-102 reduced itching, but generally to a lesser degree than 0.5% ADX-102, suggesting a dose-related efficacy response that confirms the biological effect of drug.

Todd C. Brady, M.D., Ph.D., president and CEO of Aldeyra Therapeutics, commented:

The consistent statistically significant reductions in ocular itching scores during the late phase of ocular allergy observed in Phase 2a and Phase 2b clinical trials have confirmed the clinical activity of our lead aldehyde trap, ADX-102, and strengthened our confidence in continued clinical development as a potentially differentiated product for the large worldwide market of allergic conjunctivitis patients whose symptoms are not relieved by standard of care antihistamines. While the one-point improvement relative to control component of the primary endpoint was not met, the threshold was approached in seasonal allergy patients, with peak changes of 0.8, and was exceeded on a percent change basis in this population 30 to 60 minutes after allergen challenge, which we believe represents a novel activity profile that addresses late phase inflammation generally not affected by antihistamines.

Shares of Aldeyra were last seen down 11% at $4.55 on Wednesday, with a consensus analyst price target of $19.20 and a 52-week range of $3.80 to $8.19.