ADX-629 / Aldeyra - LARVOL DELTA

ADX-629 Therapy for Sjogren-Larsson Syndrome (clinicaltrials.gov) - P1/2 | N=8 | Active, not recruiting | Sponsor: University of Nebraska | Recruiting ➔ Active, not recruiting

Enrollment closed

ADX-629-ALH-001: A Clinical Trial Investigating the Safety and Efficacy of Subjects With Alcoholic Hepatitis (Part 1) (clinicaltrials.gov) - P2 | N=10 | Recruiting | Sponsor: Aldeyra Therapeutics, Inc. | Trial completion date: Dec 2024 ➔ Dec 2025 | Trial primary completion date: Dec 2024 ➔ Dec 2025

Trial completion date • Trial primary completion date • Hepatology • Inflammation

A Clinical Trial Investigating the Safety and Efficacy of Subjects with Alcoholic Hepatitis (Part 1) (clinicaltrials.gov) - P2 | N=10 | Recruiting | Sponsor: Aldeyra Therapeutics, Inc.

New P2 trial • Hepatology • Inflammation

A Clinical Trial in Subjects With Atopic Dermatitis (Part 1) (clinicaltrials.gov) - P2 | N=8 | Completed | Sponsor: Aldeyra Therapeutics, Inc. | Recruiting ➔ Completed | Trial completion date: Dec 2024 ➔ Nov 2023 | Trial primary completion date: Dec 2024 ➔ Nov 2023

Trial completion • Trial completion date • Trial primary completion date • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Aldeyra Therapeutics Highlights Recent Preclinical Data in Obesity, Atopic Dermatitis, Pain, and Alcoholic Hepatitis, and Announces Planned Pivotal Clinical Trial in Retinitis Pigmentosa, at 2024 Research & Development Day (Businesswire) - "Aldeyra will present new preclinical data from investigational RASP modulators in animal models for obesity, atopic dermatitis, inflammatory pain, and alcoholic hepatitis. In the diet-induced model of obesity, ADX-629 decreased weight and fat mass alone and in combination with a GLP-1 agonist. In the oxazolone model of atopic dermatitis, RASP modulators ADX-629, ADX-246, and ADX-248 demonstrated activity in reducing skin thickness and erosion, and in reducing spleen to body weight ratio. In the carrageenan model of inflammatory pain, ADX-246 increased tolerance to mechanical and thermal pain, and decreased joint swelling. Consistent with previously released data from ADX-629 in a model of alcoholic hepatitis, ADX-246 reduced levels of fibrosis and fat in liver."

Preclinical • Atopic Dermatitis • Immunology

Part 1 - A Clinical Trial in Patients With Frequently Relapsing and Steroid-Dependent Nephrotic Syndrome (clinicaltrials.gov) - P2 | N=0 | Withdrawn | Sponsor: Aldeyra Therapeutics, Inc. | Not yet recruiting ➔ Withdrawn

Trial withdrawal • Glomerulonephritis • Nephrology • Renal Disease

ADX-629 Therapy for Sjogren-Larsson Syndrome (clinicaltrials.gov) - P1/2 | N=10 | Recruiting | Sponsor: University of Nebraska | Trial completion date: Dec 2023 ➔ Jun 2025 | Trial primary completion date: Dec 2023 ➔ Jun 2025

Trial completion date • Trial primary completion date

Aldeyra Therapeutics Announces Statistically Significant Reduction in Cough Frequency in Phase 2 Clinical Trial of ADX‑629 in Patients With Chronic Cough (Businesswire) - P2 | N=51 | "Aldeyra Therapeutics, Inc...announced positive top-line results from the Phase 2 clinical trial of orally administered ADX‑629, an investigational new drug, in patients with chronic cough...Relative to placebo, statistical significance was achieved for the key secondary endpoint of reduction in awake cough frequency (P=0.01), the secondary endpoint of 24-hour cough frequency (P=0.001), and the related post-hoc analyses of awake cough count (P=0.001) and 24-hour cough count (P=0.001). Quality of life and clinical impression scales did not consistently change between treatment groups over the two-week treatment periods. ADX‑629 was well tolerated, and no safety concerns were identified...A Phase 2 clinical trial of ADX‑629 in moderate alcohol-associated hepatitis is expected to initiate in the second half of 2023."

P2 data • Chronic Cough • Cough • Immunology • Respiratory Diseases

A Clinical Trial to Evaluate the Safety and Efficacy in Subjects With Chronic Cough (clinicaltrials.gov) - P2 | N=51 | Completed | Sponsor: Aldeyra Therapeutics, Inc. | Recruiting ➔ Completed | Trial completion date: Dec 2023 ➔ Apr 2023 | Trial primary completion date: Dec 2023 ➔ Apr 2023

Trial completion • Trial completion date • Trial primary completion date • Chronic Cough • Cough • Pulmonary Disease • Respiratory Diseases

Aldeyra Therapeutics Schedules Conference Call and Webcast to Announce Top-Line Results from the Phase 2 Clinical Trial of ADX‑629 in Patients with Chronic Cough (Businesswire) - "Aldeyra Therapeutics...announced it will host a webcast and conference call on Tuesday, June 27, 2023, at 8:00 a.m. (ET) to provide top-line results from the Phase 2 clinical trial of ADX‑629 in patients with chronic cough."

P2 data • Chronic Cough • Cough • Respiratory Diseases

Aldeyra Therapeutics Reports First-Quarter 2023 Financial Results and Recent Corporate Highlights (Businesswire) - "Top-Line Results from the Phase 2 Clinical Trial of ADX-629 in Chronic Cough Expected in the Second Quarter of 2023."

P2 data • Chronic Cough

Aldeyra Therapeutics Announces Completion of Enrollment in Phase 2 Clinical Trial of ADX-629 in Chronic Cough (Businesswire) - “Aldeyra Therapeutics, Inc…announced the completion of enrollment in the Phase 2 clinical trial of the orally administered RASP modulator ADX-629, an investigational new drug, for the treatment of chronic cough.Top-line results are expected in the first half of 2023.”

Enrollment closed • P2 data • Chronic Cough • Cough • Respiratory Diseases

A Clinical Trial in Subjects With Atopic Dermatitis (Part 1) (clinicaltrials.gov) - P2 | N=10 | Recruiting | Sponsor: Aldeyra Therapeutics, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

ADX-629, A Reactive Aldehyde Species (RASP) Inhibitor, Reduced Eosinophilia In Asthmatic Subjects After Bronchial Allergen Challenge (BAC) (AAAAI 2023) - "This clinical trial suggests that ADX-629 was well-tolerated and may provide a protective effect by reducing EOS infiltration. Further studies are warranted in more asthmatics to elucidate where in the inflammatory pathway RASP inhibitors may intervene to reduce airway eosinophilia in atopic asthma."

Clinical • Asthma • Eosinophilia • Immunology • Pulmonary Disease • Respiratory Diseases

Aldeyra Therapeutics Advances Investigational Oral RASP Modulator ADX‑629 Into New Phase 2 Systemic Disease Trials (Businesswire) - “Chronic Cough: ADX-629 is currently being evaluated in a multicenter, randomized, double-blind, placebo-controlled, two-period Phase 2 crossover trial in approximately 50 patients with refractory or unexplained chronic cough. Top-line results are expected in the first half of 2023.”

P2 data • Chronic Cough • Cough

A Clinical Trial in Subjects With Atopic Dermatitis (Part 1) (clinicaltrials.gov) - P2 | N=10 | Not yet recruiting | Sponsor: Aldeyra Therapeutics, Inc.

New P2 trial • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

A Clinical Trial to Evaluate the Safety and Efficacy of ADX-629 in in Subjects With Elevated Ethanol Levels (clinicaltrials.gov) - P1/2 | N=26 | Completed | Sponsor: Aldeyra Therapeutics, Inc. | Recruiting ➔ Completed | Trial completion date: Dec 2022 ➔ May 2022 | Trial primary completion date: Dec 2022 ➔ May 2022

Trial completion • Trial completion date • Trial primary completion date

Aldeyra Therapeutics’ Investigational RASP Modulator ADX-629 Improved Signs of Intoxication in Alcohol Challenge Phase 2 Clinical Trial (Businesswire) - "'The evidence of activity of ADX-629 following acute alcohol intoxication is encouraging given the paucity of treatment options for patients with alcohol-associated liver diseases,' stated Loretta L. Jophlin, M.D., Ph.D...'For patients with moderate alcohol-associated hepatitis, standard of care is generally observation, and thus there is demand for potential new therapies such as ADX-629 that could prevent disease progression or otherwise improve outcomes.'"

Media quote

A novel reactive aldehyde species inhibitor prevents the deleterious effects of ethanol in an animal model of alcoholic liver disease. (PubMed, Int Immunopharmacol) - "These findings demonstrate that the use of this unique RASP inhibitor (ADX-629) is effective in the treatment of ALD. Given the ubiquitous nature of aldehydes in the context of tissue inflammation and damage, ADX-629 and other RASP inhibitors may have additional applications in disease states."

Journal • Preclinical • Hepatology • Immunology • Inflammation • IFNG

ADX-629 Therapy for Sjogren-Larsson Syndrome (clinicaltrials.gov) - P1/2 | N=10 | Recruiting | Sponsor: William Rizzo, MD | Not yet recruiting ➔ Recruiting | Trial completion date: May 2023 ➔ Dec 2023 | Initiation date: Oct 2022 ➔ Jan 2023 | Trial primary completion date: Dec 2022 ➔ Dec 2023

Enrollment open • Trial completion date • Trial initiation date • Trial primary completion date

Part 1 - A Clinical Trial in Patients With Frequently Relapsing and Steroid-Dependent Nephrotic Syndrome (clinicaltrials.gov) - P2 | N=5 | Not yet recruiting | Sponsor: Aldeyra Therapeutics, Inc.

New P2 trial • Glomerulonephritis • Nephrology • Renal Disease

TREATMENT OF PRECISION CUT LIVER SLICES (PCLS) EXPOSED TO ETHANOL WITH ADX-629 PREVENTS TRIGLYCERIDE ACCUMULATION. (AASLD 2022) - "This study demonstrates the effective treatment of PCLSs with ADX-629, a unique RASP inhibitor, in the prevention of fatty liver due to ethanol metabolism. ADX-629 scavenged AA produced by ethanol metabolism and reduced the formation of triglycerides. This drug may be a useful tool for the treatment of ALD and potentially fatty liver."

Fibrosis • Hepatology • Immunology

A Clinical Trial to Evaluate the Safety and Efficacy of ADX-629 in in Subjects With Elevated Ethanol Levels (clinicaltrials.gov) - P1/2 | N=30 | Recruiting | Sponsor: Aldeyra Therapeutics, Inc.

New P1/2 trial

ADX-629 Therapy for Sjogren-Larsson Syndrome (clinicaltrials.gov) - P1/2 | N=10 | Not yet recruiting | Sponsor: William Rizzo, MD

New P1/2 trial

A Clinical Trial to Evaluate the Safety and Efficacy in Subjects With Chronic Cough (clinicaltrials.gov) - P2 | N=50 | Recruiting | Sponsor: Aldeyra Therapeutics, Inc.

New P2 trial • Chronic Cough • Cough • Pulmonary Disease • Respiratory Diseases