Shares of Aldeyra Therapeutics $ALDX soared in pre-market trading Wednesday as the biotech touted positive data for its lead drug in treating dry eye disease. But the frenzy also started to wane rather early as the data got a second look from skeptics.
Their drug is reproxalap, and their statement zeroed in on the statistically significant scores researchers recorded in a Phase IIb trial, coming in somewhere under the wire at a p value of <0.05 for two doses rated on the Four-Symptom Ocular Dryness Score and the Overall Ocular Discomfort Symptom Score.
But one of the slides on the company’s presentation caught the attention of some observers.
The high dose hit at week 8, but then lost statistical significance at week 12 — while the low dose outperformed the high dose at week 12. That raised some questions about durability and dose response, but the stock was still up 28% this morning after initially rocketing up more than 50%.
Aldeyra says that it is now prepping a Phase III after learning a few things in the mid-stage trial.
“The addition of dry eye disease to our late-stage clinical portfolio, which includes Phase III clinical trials in allergic conjunctivitis and noninfectious anterior uveitis, highlights the potential of reproxalap as a highly differentiated and novel ophthalmic therapy,” notes CEO Todd Brady in a statement.
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