Aldeyra Therapeutics Announces Initiation of Phase 2 Clinical Trials of ADX-629, a First-in-Class Orally Administered RASP Inhibitor, for the Treatment of COVID-19, Atopic Asthma, and Psoriasis

Rhea-AI Summary

Aldeyra Therapeutics (Nasdaq: ALDX) has initiated Phase 2 clinical trials for ADX-629, a novel orally administered reactive aldehyde species (RASP) inhibitor targeting COVID-19, atopic asthma, and psoriasis. This follows a successful Phase 1 trial showing no adverse events and reduced RASP levels. The COVID-19 trial will enroll around 30 patients to assess safety and efficacy, the asthma trial will involve 12 patients, and the psoriasis study will include 10 patients. The aim is to broaden the application of ADX-629 beyond ocular diseases.

Positive

• Successful Phase 1 trial for ADX-629 with no adverse events.
• Potential broad applicability of ADX-629 to systemic immune-mediated diseases.

Negative

• None.

Aldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra) today announced the initiation of Phase 2 clinical trials of ADX-629, a first-in-class orally administered reactive aldehyde species (RASP) inhibitor, for the treatment of COVID-19, atopic asthma, and psoriasis as part of a systematic strategy to assess activity across different types of immunological diseases. The Phase 2 clinical trials follow a successful Phase 1 clinical trial of ADX-629, which demonstrated no treatment-related adverse events at any dose tested, as well as target engagement evidenced by statistically lower RASP levels in drug-treated subjects relative to controls.

“The initiation of Phase 2 clinical testing of ADX-629, a first-in-class orally administered RASP inhibitor, is an exciting milestone for Aldeyra as we broaden the focus of our RASP platform from ocular indications to systemic disease,” stated Todd C. Brady, M.D., Ph.D., President and CEO of Aldeyra. “The Phase 2 clinical trials announced today underscore our mission to develop new therapies that improve patient outcomes by fine-tuning the body’s immune response. Unlike traditional immunologic drugs, ADX-629 is designed to modulate the immune system rather than shut down singular molecular targets, an approach that may lead to toxicity.”

COVID-19 – A Clinical Model of Cytokine Release Syndrome

The multi-center, double-blind, placebo-controlled, parallel-group Phase 2 clinical trial in COVID-19 will evaluate the safety, tolerability, efficacy, and pharmacodynamics of ADX-629 in adult patients. Approximately 30 patients will be randomized to receive either 300 mg of ADX-629 or placebo twice daily for up to 28 days. Key endpoints will include the National Institute of Allergy and Infectious Diseases COVID-19 scale and plasma levels of cytokines and RASP. Enrollment is expected to begin by year-end.

Atopic Asthma – A Clinical Model of Allergic Inflammation

The single-center, double-masked, placebo-controlled, crossover Phase 2 clinical trial will assess the safety and efficacy of ADX-629 in adult patients with mild asthma induced by bronchial asthma challenge. Twelve patients with cat or house dust mite allergen-induced asthma will be randomized to receive either 600 mg of ADX-629 or placebo twice daily for approximately one week. Outcomes will include pulmonary function testing following allergen and methacholine challenge, sputum eosinophil counts, and plasma levels of cytokines and RASP. Enrollment is expected to begin in the first quarter of 2021.

Psoriasis – A Clinical Model of Autoimmune Disease

The multi-center, open-label, single-group Phase 2 clinical trial will assess the safety and efficacy of ADX-629 in adult patients with mild to moderate plaque psoriasis. Ten adult patients will receive 250 mg of ADX-629 twice daily for up to 90 days. Outcomes will include psoriasis area and severity index, skin cytokine transcription profiles, plasma leukocyte cytokine release following endotoxin-challenge, and plasma levels of cytokines and RASP. Enrollment is expected to begin in the first half of next year.

“We believe that ADX-629 has broad applicability to systemic immune-mediated diseases,” Dr. Brady said. “We look forward to characterizing more fully the immune modulating activity of ADX-629 in multiple types of severe inflammation.”

About ADX-629

ADX-629 is a novel orally administered RASP inhibitor in Phase 2 clinical development for the treatment of immune-mediated diseases. RASP inhibitors potentially represent upstream immunological switches that modulate immune systems from pro-inflammatory states to anti-inflammatory states. ADX-629 is a member of the same chemical class as reproxalap, a RASP inhibitor in Phase 3 clinical trials for dry eye disease and allergic conjunctivitis, two common ocular inflammatory diseases.

About Aldeyra Therapeutics

Aldeyra Therapeutics is a clinical-stage biotechnology company focused on the development of novel therapies with the potential to improve the lives of patients with immune-mediated diseases. Two of the company’s lead compounds, reproxalap and ADX-629, target RASP (reactive aldehyde species), which are elevated in ocular and systemic inflammatory disease and result in cytokine release via activation of a broad array of inflammatory factors, including NF-κB, inflammasomes, and Scavenger Receptor A. Reproxalap is being evaluated in Phase 3 clinical trials in patients with dry eye disease and allergic conjunctivitis. The company’s clinical pipeline also includes ADX-2191, a dihydrofolate reductase inhibitor in Phase 3 testing for proliferative vitreoretinopathy, and ADX-1612, a chaperome inhibitor in development for COVID-19 and ovarian cancer. For more information, visit https://www.aldeyra.com/ and follow us on LinkedIn, Facebook, and { "@context": "https://schema.org", "@type": "FAQPage", "name": "Aldeyra Therapeutics Announces Initiation of Phase 2 Clinical Trials of ADX-629, a First-in-Class Orally Administered RASP Inhibitor, for the Treatment of COVID-19, Atopic Asthma, and Psoriasis FAQs", "mainEntity": [ { "@type": "Question", "name": "What is the purpose of Aldeyra's Phase 2 clinical trials for ADX-629?", "acceptedAnswer": { "@type": "Answer", "text": "The Phase 2 trials aim to evaluate the safety and efficacy of ADX-629 for treating COVID-19, atopic asthma, and psoriasis." } }, { "@type": "Question", "name": "When is enrollment expected to begin for the ADX-629 COVID-19 trial?", "acceptedAnswer": { "@type": "Answer", "text": "Enrollment for the COVID-19 trial is expected to begin by year-end." } }, { "@type": "Question", "name": "How many patients will be involved in the Phase 2 asthma trial?", "acceptedAnswer": { "@type": "Answer", "text": "The asthma trial will involve 12 patients." } }, { "@type": "Question", "name": "What are the key endpoints for the COVID-19 trial of ADX-629?", "acceptedAnswer": { "@type": "Answer", "text": "Key endpoints include the COVID-19 scale and plasma levels of cytokines and RASP." } }, { "@type": "Question", "name": "What makes ADX-629 different from traditional immunologic drugs?", "acceptedAnswer": { "@type": "Answer", "text": "ADX-629 modulates the immune system rather than shutting down singular molecular targets, potentially reducing toxicity." } } ] }

FAQ

What is the purpose of Aldeyra's Phase 2 clinical trials for ADX-629?

The Phase 2 trials aim to evaluate the safety and efficacy of ADX-629 for treating COVID-19, atopic asthma, and psoriasis.

When is enrollment expected to begin for the ADX-629 COVID-19 trial?

Enrollment for the COVID-19 trial is expected to begin by year-end.

How many patients will be involved in the Phase 2 asthma trial?

The asthma trial will involve 12 patients.

What are the key endpoints for the COVID-19 trial of ADX-629?

Key endpoints include the COVID-19 scale and plasma levels of cytokines and RASP.

What makes ADX-629 different from traditional immunologic drugs?

ADX-629 modulates the immune system rather than shutting down singular molecular targets, potentially reducing toxicity.