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Aldeyra's Eye Inflammation Drug Aces Late-Stage Trial, Stock Rises 60%

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Aldeyra's Eye Inflammation Drug Aces Late-Stage Trial, Stock Rises 60%

Aldeyra Therapeutics Inc (NASDAQ: ALDX) shares are advancing strongly Tuesday following the release of the results of a late-stage study of its drug candidate for allergic conjunctivitis.

What Happened

Aldeyra said a Phase 3 trial, dubbed ALLEVIATE, that evaluated 0.25 percent and 0.5 percent doses of reproxalap topical ophthalmic solutions in patients with allergic conjunctivitis met the primary and key secondary endpoints for both concentrations.

The trial was designed as a double-masked, vehicle-controlled, multi-center study and evaluated 318 patients with seasonal allergic conjunctivitis.

Treated patients with 0.25 percent and 0.5 percent concentration of reproxalap showed a statistically-significant reduction in ocular itching, relative to patients treated with vehicle.

Reproxalap has an anti-inflammatory profile, distinct from the standard-of-care antihistamine therapy.

Why It's Important

Cantor Fitzgerald analyst Elemer Piros said in a note he raised the risk-adjusted probability for the program from 30 percent to 60 percent, which increases the NPV from $125 million to $270 million.

The company also said it has entered into a Loan and Security agreement with Hercules Capital to provide up to $60 million in non-dilutive financing.

"Coupled with the $94 million cash (YE18), we think Aldeyra has sufficient cash to execute its clinical programs near term," Piros wrote in the note.

Reproxalap, the company's lead asset, is being tested in late-stage trials for three indications, namely allergic conjunctivitis, non-infectious anterior uveitis, and dry eye disease.

"The ALLEVIATE results suggest the potential of topical ocular reproxalap as a novel, safe, and effective therapeutic option that could be used to complement existing therapy before resorting to corticosteroids, which can lead to serious ocular toxicity," said David Clark, Aldeyra's Chief Medical Officer.

What's Next

Aldeyra is conducting clinical method development studies to test the feasibility of measuring ocular itching induced by environmental exposure to allergen. The company plans to meet with the FDA in the second half of 2019 to discuss the results of the ALLEVIATE trial and the remaining clinical requirements for a potential NDA submission.

Cantor Fitzgerald reiterated an Overweight rating on Aldeyra and lifted the price target from $30 to $35.

In pre-market trading, Aldeyra shares were higher by nearly 60 percent to $11.24 at time of publication.

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Latest Ratings for ALDX

DateFirmActionFromTo
Dec 2018CitigroupInitiates Coverage OnBuy
Sep 2018Stifel NicolausMaintainsBuyBuy
Sep 2018Janney CapitalInitiates Coverage OnBuy

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