Previously Announced Phase 2 Clinical Trials Initiated in Minimal Change Disease and Sjögren‑Larsson Syndrome
Phase 2 Clinical Trial in Minimal Change Disease Expanded to Encompass Idiopathic Nephrotic Syndrome, a Broad Group of Rare Kidney Disorders
New Phase 2 Clinical Trial Initiated in Atopic Dermatitis
Previously Announced Credit Facility Amendment Extends Cash Runway into the Second Half of 2024
LEXINGTON, MA, USA I February 16, 2023 IAldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra) today announced the initiation of Phase 2 clinical trials evaluating the safety and efficacy of ADX‑629, a novel, internally developed, investigational oral RASP modulator, for the treatment of minimal change disease and Sjögren-Larsson Syndrome. Aldeyra also announced the expansion of the minimal change disease clinical trial to encompass idiopathic nephrotic syndrome, a broad group of rare immune-mediated kidney disorders that includes minimal change disease. Additionally, Aldeyra announced the initiation of a Phase 2 clinical trial of ADX‑629 in atopic dermatitis.
“Following the completion of successful proof-of-concept trials in psoriasis, asthma, COVID-19, and alcohol toxicity, the ADX‑629 trials announced today further advance the promising novel pharmacology of our proprietary RASP modulator platform for the treatment of systemic diseases,” said Todd C. Brady, M.D., Ph.D., President and Chief Executive Officer of Aldeyra. “ADX-629 has the potential to become a first-in-class therapy that may allow for convenient, non-injected, orally administered, broad-based treatment of immune-mediated diseases.
“With the recently amended credit facility, we believe that our cash runway is extended into the second half of 2024 and that we are well positioned to advance our novel investigational product candidates for systemic diseases while executing on initial commercialization activities for reproxalap and ADX-2191, if approved,” Dr. Brady stated.
Disease Targets
- Idiopathic Nephrotic Syndrome: Idiopathic nephrotic syndrome is comprised of a broad group of renal inflammatory diseases, including minimal change disease, and is characterized by edema, proteinuria, and hypoalbuminemia. The adaptive, multicenter, two‑part Phase 2 clinical trial will evaluate the safety and efficacy of ADX‑629 and placebo over 12 weeks of treatment in children and adults. Part 1 is expected to enroll five patients who will be treated with ADX‑629. Pending the results of Part 1, Part 2 will compare ADX‑629 to placebo. Outcomes will include frequency of relapse, as defined by requirement for corticosteroid therapy. Top-line results from Part 1 of the clinical trial are expected in 2023.
- Sjögren-Larsson Syndrome: Sjögren-Larsson Syndrome is an autosomal recessive neurocutaneous inborn error of metabolism that prevents degradation of specific RASP, and most commonly affects children and adolescents. The investigator-sponsored, open-label, Phase 1/2 clinical trial will evaluate the safety, pharmacodynamics, and exploratory clinical activity in up to 10 patients over 12 weeks of treatment. Outcomes will include plasma and imaging markers of metabolism and brain activity, quality of life, neurological function, and skin assessments. Top-line results are expected in 2023.
- Atopic Dermatitis: Atopic dermatitis is a chronic hypersensitivity condition that is characterized by dry, itchy, and inflamed skin, and commonly affects children and adults. The adaptive, multicenter, two-part Phase 2 clinical trial will evaluate the safety and efficacy of ADX‑629 over 12 weeks of treatment. Part 1 of the trial is expected to enroll approximately 10 patients. Pending the results of Part 1, Part 2 will compare ADX-629 to placebo. Outcomes will include improvement in Investigator Global Assessment and Eczema Area and Severity Index scores. Top-line results from Part 1 of the clinical trial are expected in 2023.
In addition to the trials in idiopathic nephrotic syndrome, Sjögren-Larsson Syndrome, and atopic dermatitis, the ADX-629 program includes the following clinical development initiatives:
- 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.
- Moderate Alcohol-Associated Hepatitis: Aldeyra plans to support an investigator-sponsored Phase 2 clinical trial of ADX‑629 in moderate alcohol-associated hepatitis. The trial is expected to be initiated in 2023. In a Phase 2 clinical trial announced last year, ADX-629 reduced dermal flushing and improved balance time following alcohol intoxication.
About ADX‑629
ADX‑629 is a novel, orally administered investigational RASP modulator for the potential treatment of systemic and retinal immune-mediated diseases. RASP modulators potentially represent upstream immunological switches that shift immune systems from pro-inflammatory states to anti-inflammatory states. ADX-629 is a member of the same chemical class as reproxalap, an investigational new drug under New Drug Application review for the treatment of dry eye disease, a common ocular inflammatory disease.
About Aldeyra
Aldeyra Therapeutics is a clinical-stage biotechnology company developing innovative therapies designed to treat immune-mediated diseases. Our approach is to discover pharmaceuticals that modulate immunological systems, instead of directly inhibiting or activating single protein targets, with the goal of optimizing multiple pathways at once while minimizing toxicity. Our pre-commercial product candidates are reproxalap, a potential treatment for dry eye disease and allergic conjunctivitis, and ADX-2191, a potential treatment for primary vitreoretinal lymphoma, proliferative vitreoretinopathy, and retinitis pigmentosa. In addition, we are developing other product candidates, including ADX-629 and chemically related molecules, for the potential treatment of systemic and retinal immune-mediated diseases. For more information, visit https://www.aldeyra.com/ and follow us on LinkedIn, Facebook, and Twitter.
SOURCE: Aldeyra Therapeutics
Post Views: 362
Previously Announced Phase 2 Clinical Trials Initiated in Minimal Change Disease and Sjögren‑Larsson Syndrome
Phase 2 Clinical Trial in Minimal Change Disease Expanded to Encompass Idiopathic Nephrotic Syndrome, a Broad Group of Rare Kidney Disorders
New Phase 2 Clinical Trial Initiated in Atopic Dermatitis
Previously Announced Credit Facility Amendment Extends Cash Runway into the Second Half of 2024
LEXINGTON, MA, USA I February 16, 2023 IAldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra) today announced the initiation of Phase 2 clinical trials evaluating the safety and efficacy of ADX‑629, a novel, internally developed, investigational oral RASP modulator, for the treatment of minimal change disease and Sjögren-Larsson Syndrome. Aldeyra also announced the expansion of the minimal change disease clinical trial to encompass idiopathic nephrotic syndrome, a broad group of rare immune-mediated kidney disorders that includes minimal change disease. Additionally, Aldeyra announced the initiation of a Phase 2 clinical trial of ADX‑629 in atopic dermatitis.
“Following the completion of successful proof-of-concept trials in psoriasis, asthma, COVID-19, and alcohol toxicity, the ADX‑629 trials announced today further advance the promising novel pharmacology of our proprietary RASP modulator platform for the treatment of systemic diseases,” said Todd C. Brady, M.D., Ph.D., President and Chief Executive Officer of Aldeyra. “ADX-629 has the potential to become a first-in-class therapy that may allow for convenient, non-injected, orally administered, broad-based treatment of immune-mediated diseases.
“With the recently amended credit facility, we believe that our cash runway is extended into the second half of 2024 and that we are well positioned to advance our novel investigational product candidates for systemic diseases while executing on initial commercialization activities for reproxalap and ADX-2191, if approved,” Dr. Brady stated.
Disease Targets
- Idiopathic Nephrotic Syndrome: Idiopathic nephrotic syndrome is comprised of a broad group of renal inflammatory diseases, including minimal change disease, and is characterized by edema, proteinuria, and hypoalbuminemia. The adaptive, multicenter, two‑part Phase 2 clinical trial will evaluate the safety and efficacy of ADX‑629 and placebo over 12 weeks of treatment in children and adults. Part 1 is expected to enroll five patients who will be treated with ADX‑629. Pending the results of Part 1, Part 2 will compare ADX‑629 to placebo. Outcomes will include frequency of relapse, as defined by requirement for corticosteroid therapy. Top-line results from Part 1 of the clinical trial are expected in 2023.
- Sjögren-Larsson Syndrome: Sjögren-Larsson Syndrome is an autosomal recessive neurocutaneous inborn error of metabolism that prevents degradation of specific RASP, and most commonly affects children and adolescents. The investigator-sponsored, open-label, Phase 1/2 clinical trial will evaluate the safety, pharmacodynamics, and exploratory clinical activity in up to 10 patients over 12 weeks of treatment. Outcomes will include plasma and imaging markers of metabolism and brain activity, quality of life, neurological function, and skin assessments. Top-line results are expected in 2023.
- Atopic Dermatitis: Atopic dermatitis is a chronic hypersensitivity condition that is characterized by dry, itchy, and inflamed skin, and commonly affects children and adults. The adaptive, multicenter, two-part Phase 2 clinical trial will evaluate the safety and efficacy of ADX‑629 over 12 weeks of treatment. Part 1 of the trial is expected to enroll approximately 10 patients. Pending the results of Part 1, Part 2 will compare ADX-629 to placebo. Outcomes will include improvement in Investigator Global Assessment and Eczema Area and Severity Index scores. Top-line results from Part 1 of the clinical trial are expected in 2023.
In addition to the trials in idiopathic nephrotic syndrome, Sjögren-Larsson Syndrome, and atopic dermatitis, the ADX-629 program includes the following clinical development initiatives:
- 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.
- Moderate Alcohol-Associated Hepatitis: Aldeyra plans to support an investigator-sponsored Phase 2 clinical trial of ADX‑629 in moderate alcohol-associated hepatitis. The trial is expected to be initiated in 2023. In a Phase 2 clinical trial announced last year, ADX-629 reduced dermal flushing and improved balance time following alcohol intoxication.
About ADX‑629
ADX‑629 is a novel, orally administered investigational RASP modulator for the potential treatment of systemic and retinal immune-mediated diseases. RASP modulators potentially represent upstream immunological switches that shift immune systems from pro-inflammatory states to anti-inflammatory states. ADX-629 is a member of the same chemical class as reproxalap, an investigational new drug under New Drug Application review for the treatment of dry eye disease, a common ocular inflammatory disease.
About Aldeyra
Aldeyra Therapeutics is a clinical-stage biotechnology company developing innovative therapies designed to treat immune-mediated diseases. Our approach is to discover pharmaceuticals that modulate immunological systems, instead of directly inhibiting or activating single protein targets, with the goal of optimizing multiple pathways at once while minimizing toxicity. Our pre-commercial product candidates are reproxalap, a potential treatment for dry eye disease and allergic conjunctivitis, and ADX-2191, a potential treatment for primary vitreoretinal lymphoma, proliferative vitreoretinopathy, and retinitis pigmentosa. In addition, we are developing other product candidates, including ADX-629 and chemically related molecules, for the potential treatment of systemic and retinal immune-mediated diseases. For more information, visit https://www.aldeyra.com/ and follow us on LinkedIn, Facebook, and Twitter.
SOURCE: Aldeyra Therapeutics
Post Views: 362
