Aldeyra Therapeutics Announces Positive Top-Line Results from the Phase 3 ALLEVIATE Trial in Patients with Allergic Conjunctivitis

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Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra), a biotechnology company devoted to developing and commercializing next-generation medicines to improve the lives of patients with immune-mediated diseases, announced positive results from the Phase 3 ALLEVIATE Trial of 0.25% and 0.5% reproxalap topical ophthalmic solution in patients with allergic conjunctivitis. The clinical trial met the primary endpoint and the key secondary endpoint for both concentrations of reproxalap.

“We are thrilled to announce positive results from ALLEVIATE, our first completed Phase 3 clinical trial,” commented Todd C. Brady, M.D., Ph.D., President and CEO of Aldeyra. “Consistent with positive results from five prior Phase 2 clinical trials in ocular inflammation, today’s announcement confirms the potential of reproxalap as a novel and clinically meaningful approach for the treatment of allergic conjunctivitis. Given that approximately half of allergic conjunctivitis patients also suffer from ocular dryness, we believe the ALLEVIATE results highlight the relevance of reproxalap to our current Phase 3 program in dry eye disease.”

The double-masked, randomized, vehicle-controlled, multi-center, parallel-group conjunctival allergen challenge Phase 3 ALLEVIATE trial assessed the efficacy and safety of 0.25% and 0.5% concentrations of reproxalap topical ophthalmic solutions compared to vehicle in 318 patients (approximately 100 per arm) with seasonal allergic conjunctivitis. The primary efficacy endpoint was the evaluation of ocular itch score (0 to 4 scale) area under the curve from 10 to 60 minutes after allergen challenge, and the key secondary endpoint was two-point responder rate, a measure of clinical relevance.

Relative to patients treated with vehicle, patients treated with 0.25% and 0.5% reproxalap demonstrated statistically significant reduction in ocular itching (p < 0.0001 and p = 0.0025, respectively), as assessed by area under the ocular itch score curve. Two-point responder rates for 0.25% and 0.5% reproxalap were statistically greater than that of vehicle-treated patients (p = 0.0005 and p = 0.0169, respectively), confirming the clinical relevance of the observed primary endpoint improvements. Both concentrations of reproxalap exhibited an anti-inflammatory profile that is distinct from standard-of-care antihistamine therapy and supports a differentiated mechanism of action for the treatment of allergic conjunctivitis.

Topical ocular reproxalap has now been administered to over 700 patients across seven completed clinical trials. Consistent with prior clinical experience, in the ALLEVIATE trial there were no observed safety or tolerability concerns and no observed adverse events other than mild and transient instillation site irritation.

“There is a large allergic conjunctivitis patient population that is underserved by currently available medications,” stated David J. Clark, M.D., M.R.C.P., Chief Medical Officer of Aldeyra. “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.”

In preparation for subsequent clinical testing, Aldeyra is conducting clinical method development studies to assess the feasibility of measuring ocular itching induced by environmental exposure to allergen. In the second half of 2019, Aldeyra plans to meet with regulatory authorities to discuss the ALLEVIATE results and remaining clinical requirements for a potential submission of a New Drug Application to the U.S. Food and Drug Administration.

In addition to announcing the positive Phase 3 top-line results from the ALLEVIATE trial, the Company entered into a Loan and Security Agreement with Hercules Capital, Inc. that provides up to $60 million in non-dilutive financing. The facility advances capital at the Company’s option based upon certain funding conditions.

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