Results, Setbacks

Aldeyra slides as lead drug flunks a primary endpoint in PhIIb

Todd Brady, CEO Aldeyra

First things first.

Aldeyra’s Phase IIb study for its lead eye drug ADX-102 failed the primary endpoint in treating allergic conjunctivitis. And if you dig a bit you can find that in its statement today, noting that a one-point differentiation from placebo at the 5-minute time point specified for gauging the impact on ocular itching didn’t qualify for success.

But investigators for the Lexington, MA-based biotech spent much more time focusing on the positive. Specifically, the data did approach the threshold of statistical significance, researchers say, and if you looked at a variety of time points after an allergen challenge — demonstrating “a novel activity profile that addresses late phase inflammation generally not affected by antihistamines” — there was a significant benefit for patients.

Investors’ first reaction was that the glass was half empty at Aldeyra, and the stock $ALDX slid 15% in pre-market trading.

The company enrolled 154 patients in the study and researchers say they are primed to go into Phase III with their 0.5% dose after the 0.1% dose fared poorly.

“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,” commented Aldeyra CEO Todd Brady in a statement.


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