Aldeyra Therapeutics Completes Enrollment in Part 1 of the Phase 3 GUARD Trial of ADX-2191 in Proliferative Vitreoretinopathy

Rhea-AI Summary

Aldeyra Therapeutics (ALDX) has completed enrollment for Part 1 of its Phase 3 GUARD Trial evaluating ADX-2191 for preventing proliferative vitreoretinopathy (PVR), an ocular disease with no approved therapies. The trial, involving 110 patients in the U.S., aims to assess recurrent retinal detachment rates post-surgery. Results are expected in the second half of 2022. ADX-2191, a methotrexate formulation, has received fast track and orphan drug designations from the FDA, potentially expediting development and offering market exclusivity.

Positive

• Completion of patient enrollment in the Phase 3 GUARD Trial for ADX-2191.
• Potential to be the first approved treatment for PVR in the U.S.
• Expected top-line results from the trial in the second half of 2022.
• Fast track and orphan drug designations from the FDA for ADX-2191.

Negative

• None.

LEXINGTON, Mass.--(BUSINESS WIRE)-- Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra), a biotechnology company discovering and developing innovative therapies for the treatment of immune-mediated diseases, today announced completion of enrollment in Part 1 of the Phase 3 GUARD Trial of ADX-2191 (intravitreal methotrexate 0.8%) in patients with proliferative vitreoretinopathy (PVR), a rare, sight-threatening ocular disease with no approved therapy.

The GUARD Trial is a two-part, multi-center, randomized, parallel-group, adaptive Phase 3 clinical trial evaluating the efficacy of intravitreal injections of ADX-2191 versus standard of care (routine monitoring) for the prevention of PVR following retinal detachment repair. The primary endpoint is recurrent retinal detachment rates over a 24-week post-operative period. Part 1 of the GUARD Trial, which enrolled 110 patients, is being conducted in the United States. Top-line results from Part 1 are expected in the second half of 2022.

“ADX-2191 has the potential to become the first drug in the U.S. indicated for the prevention of PVR, a sight-threatening condition for which there is no approved treatment,” stated Todd C. Brady, M.D., Ph.D., President and Chief Executive Officer of Aldeyra. “Clinical results suggest that methotrexate, the active ingredient of ADX-2191, may diminish the rates of retinal detachment and improve visual outcomes in thousands of patients who undergo surgery for PVR.”

ADX-2191, a vitreous-compatible formulation of methotrexate, has been granted fast track and orphan drug designation by the U.S. Food and Drug Administration for the prevention of PVR. Fast track designation is designed to facilitate the development and expedite the review of drugs that treat serious conditions, potentially accelerating patient access to new therapies. Orphan drug designation qualifies sponsors for incentives including tax credits for qualified clinical trials; exemption from user fees; and market exclusivity after approval, if received.

About Aldeyra Therapeutics

Aldeyra Therapeutics discovers and develops innovative therapies designed to treat immune-mediated diseases. Our approach is to develop therapies designed to modulate immunological systems, without inhibiting or activating single targets, with the goal of optimizing multiple pathways at once while minimizing toxicity. Two of our lead product candidates, reproxalap and ADX-629, target pre-cytokine, systems-based mediators of inflammation known as RASP (reactive aldehyde species). Reproxalap is in Phase 3 clinical trials in patients with dry eye disease and allergic conjunctivitis. ADX-629, an orally administered RASP modulator, is in Phase 2 proof-of-concept clinical trials in psoriasis, atopic asthma, and COVID-19. Our clinical pipeline also includes ADX-2191 (intravitreal methotrexate 0.8%), in Phase 3 clinical testing for the prevention of proliferative vitreoretinopathy. For more information, visit https://www.aldeyra.com/ and follow us on LinkedIn, Facebook, and Twitter.

Safe Harbor Statement

This release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding Aldeyra's strategy, future operations, prospects, plans, and objectives and Aldeyra's plans and expectations for its product candidates, including ADX-2191. Aldeyra intends such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. In some cases, you can identify forward-looking statements by terms such as, but not limited to, "may," "might," "will," "objective," "intend," "should," "could," "can," "would," "expect," "believe," "anticipate," "project," "on track," "scheduled," "target," "design," "estimate," "predict," "potential," "aim," "plan" or the negative of these terms, and similar expressions intended to identify forward-looking statements. Such forward-looking statements are based upon current expectations that involve risks, changes in circumstances, assumptions, and uncertainties. Aldeyra is at an early stage of development and may not ever have any products that generate significant revenue. All of Aldeyra's development timelines may be subject to adjustment depending on recruitment rate, regulatory review, preclinical and clinical results, and other factors that could delay the initiation or completion of clinical trials. Important factors that could cause actual results to differ materially from those reflected in Aldeyra's forward-looking statements include, among others, the timing of enrollment, commencement and completion of Aldeyra's clinical trials; the timing and success of preclinical studies and clinical trials conducted by Aldeyra and its development partners; updated or refined data based on Aldeyra's continuing review and quality control analysis of clinical data, Aldeyra's ability to design clinical trials with protocols and endpoints acceptable to applicable regulatory authorities; delay in or failure to obtain regulatory approval of Aldeyra's product candidates; the ability to maintain regulatory approval of Aldeyra's product candidates, and the labeling for any approved products; the risk that prior results, such as signals of safety, activity or durability of effect, observed from preclinical or clinical trials, will not be replicated or will not continue in ongoing or future studies or clinical trials involving Aldeyra's product candidates in clinical trials focused on the same or on different indications; the risk that the results from earlier clinical trials, portions of clinical trials, or pooled clinical data may not accurately predict results of subsequent trials or the remainder of a clinical trial; the scope, progress, expansion, and costs of developing and commercializing Aldeyra's product candidates; uncertainty as to Aldeyra’s ability to commercialize (alone or with others) Aldeyra's product candidates following regulatory approval, if any; the size and growth of the potential markets and pricing for Aldeyra's product candidates and the ability to serve those markets; Aldeyra's expectations regarding Aldeyra's expenses and revenue, the sufficiency or use of Aldeyra's cash resources and needs for additional financing; political, economic, legal, social and health risks, including the COVID-19 pandemic and related public health measures, that may affect Aldeyra’s business or the global economy; the rate and degree of market acceptance of any of Aldeyra's product candidates; Aldeyra's expectations regarding competition; Aldeyra's anticipated growth strategies; Aldeyra's ability to attract or retain key personnel; Aldeyra’s limited sales and marketing infrastructure; Aldeyra's ability to establish and maintain development partnerships; Aldeyra’s ability to successfully integrate acquisitions into its business; Aldeyra's expectations regarding federal, state and foreign regulatory requirements; regulatory developments in the United States and foreign countries; Aldeyra's ability to obtain and maintain intellectual property protection for its product candidates; the anticipated trends and challenges in Aldeyra's business and the market in which it operates; and other factors that are described in the "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" sections of Aldeyra's Annual Report on Form 10-K for the year ended December 31, 2020 and Quarterly Report on Form 10-Q for the quarter ended September 30, 2021, which are on file with the Securities and Exchange Commission (SEC) and available on the SEC's website at https://www.sec.gov/. Additional factors may be described in those sections of Aldeyra's Annual Report on Form 10-K for the year ended December 31, 2021, expected to be filed with the SEC in the first quarter of 2022.

In addition to the risks described above and in Aldeyra's other filings with the SEC, other unknown or unpredictable factors also could affect Aldeyra's results. No forward-looking statements can be guaranteed and actual results may differ materially from such statements. The information in this release is provided only as of the date of this release, and Aldeyra undertakes no obligation to update any forward-looking statements contained in this release on account of new information, future events, or otherwise, except as required by law.

View source version on businesswire.com: https://www.businesswire.com/news/home/20220103005519/en/

Corporate Contact:

Joshua Reed

Aldeyra Therapeutics, Inc.

Tel: 781-761-4904 ext. 218

jreed@aldeyra.com

Investor & Media Contact:

Scott Solomon

Sharon Merrill Associates, Inc.

Tel: 617-542-5300

ALDX@investorrelations.com

Source: Aldeyra Therapeutics, Inc.

FAQ

What is the GUARD Trial for ADX-2191?

The GUARD Trial is a Phase 3 clinical trial evaluating the effectiveness of ADX-2191 in preventing proliferative vitreoretinopathy (PVR) after retinal detachment repair.

What are the expected results from the GUARD Trial?

Top-line results from Part 1 of the GUARD Trial are anticipated in the second half of 2022.

What designations has ADX-2191 received from the FDA?

ADX-2191 has received fast track and orphan drug designations from the FDA, facilitating its development.

How many patients were enrolled in the GUARD Trial?

Part 1 of the GUARD Trial enrolled 110 patients.

What is the significance of ADX-2191 for PVR patients?

ADX-2191 has the potential to become the first FDA-approved treatment for PVR, which currently has no approved therapies.