Watch out Claritin: Aldeyra announces clean sweep in PhIII for new allergy drug
Aldeyra Therapeutics’ stock $ALDX is surging after they posted sweeping results in a Phase III trial for their lead therapy.
Aldeyra announced Tuesday that the molecule, known as reproxalap, reduced the number of times patients with a form of seasonal allergies scratched their eyes after being exposed to ragweed pollen. It also successfully reduced tearing, redness around the eyes, and patient’s score on a scale that measures how severe their reaction was overall.
In a presentation, the biotech said the results heralded “a new paradigm” for treating inflammation at the front of the eye, touting it as potentially the first new mechanism for treating eye allergies in “decades.” Such symptoms are now commonly treated with antihistamines like Claritin.
The stock rose 28% on the news, from $11.11 to $14.18.
It’s not the first time Aldeyra’s stock has surged on a readout. The Lexington, MA-based company has focused mostly on developing reproxalap for a variety of eye diseases. Designed to target a cluster of pro-inflammatory molecules called RASP, the drug — to Aldeyra’s telling — can modulate the immune system and correct damaging or annoying inflammation.
Three years ago, they unveiled positive data from their Phase IIb trial for dry eye disease, a potentially significant market. But investors’ enthusiasm ebbed as it appeared the drug only narrowly snaked under statistical significance. A Phase III study is now underway.
This is now the second Phase III study for the candidate in allergic conjunctivitis (seasonal allergies that affect the eye), after the company announced positive results from an earlier one in 2019.
In the new study, patients with allergic conjunctivitis were randomized to receive either eye drops of reproxalap or a placebo. They were then exposed to a chamber with ragweed pollen for 3.5 hours.
Patients who received the drug reported fewer symptoms across the board. Aldeyra did not release detailed results but said P values for both the primary and secondary endpoints were p<0.0001.
It’s a strong beginning to what could be a busy year for the 17-year-old company. In addition to discussing an application for approval in allergy with the FDA, Aldeyra also plans to release results of its Phase III trial in the second half of 2021.
Correction: This article was updated to clarify that RASP are pro-inflammatory molecules, not proteins and that the drug is given by eye drops.
Social: Todd Brady, Aldeyra CEO