- Relative to Placebo, Statistical Significance Achieved for Reduction in Awake Cough Frequency (P=0.01), 24‑Hour Cough Frequency (P=0.001), Awake Cough Count (P=0.001), and 24‑Hour Cough Count (P=0.001)
- ADX-629 Was Well Tolerated and No Safety Concerns Were Identified
LEXINGTON, MA, USA I June 27, 2023 IAldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra), a biotechnology company devoted to discovering and developing innovative therapies designed to treat immune-mediated diseases, today 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. The clinical trial demonstrated statistically significant reduction in cough frequency following administration of ADX‑629 relative to placebo.
“Consistent with previously demonstrated activity in clinical trials of patients with psoriasis, asthma, and COVID-19, the reduction in cough frequency observed in the Phase 2 clinical trial in chronic cough supports the potentially broad-based activity of ADX‑629 as a novel, immune-modulating therapeutic approach,” stated Todd C. Brady, M.D., Ph.D., President and CEO of Aldeyra. “We look forward to discussing the results with regulatory authorities as we consider the expansion of clinical testing to include patients with co-morbid conditions of frequent coughing and active inflammation.”
The multicenter, randomized, double-blind, placebo-controlled, two-period Phase 2 crossover trial enrolled 51 patients with refractory or unexplained chronic cough, which is often defined as a cough that persists for more than eight weeks and is unresponsive to treatment. Patients were randomized to receive ADX-629 or placebo twice daily for 14 days, followed by a 14-day washout period prior to crossing over to 14 days of treatment with ADX‑629 or placebo, whichever was not received in the first period. The primary endpoint of the clinical trial was safety. Secondary endpoints included awake cough frequency (the key secondary endpoint), 24-hour cough frequency, quality of life, and clinical impression scales.
Fifty-one patients were enrolled, and all patients completed both treatment periods. 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 following administration of either ADX‑629 or placebo. No serious adverse events were reported, adverse event frequencies were similar across treatment groups, and no patients discontinued due to adverse events.
“Frequent coughing, which is characteristic of a number of inflammatory pulmonary diseases, represents a persistently disturbing condition for patients,” stated Gary N. Gross, MD., Clinical Professor of Internal Medicine at Southwestern Medical School and a Board-certified allergist and immunologist with the Dallas Allergy & Asthma Center. “The difficulty in treating chronic coughing highlights the medical need for new therapies.”
Consistent with a Phase 1 clinical trial and the Phase 2 clinical trial in psoriasis, improvement in LDL and HDL levels was observed following treatment with ADX‑629 relative to treatment with placebo. ADX‑629, an investigational new drug, is a novel, orally administered RASP (reactive aldehyde species) modulator for the potential treatment of systemic immune-mediated diseases. ADX‑629 is also currently in development for atopic dermatitis, idiopathic nephrotic syndrome, and Sjögren-Larsson Syndrome. Initial results from each trial are expected in the second half of 2023. A Phase 2 clinical trial of ADX‑629 in moderate alcohol-associated hepatitis is expected to initiate in the second half of 2023.
Conference Call & Webcast Information
Aldeyra will host a conference call at 8:00 a.m. ET today to discuss top-line results of the Phase 2 clinical trial of ADX‑629 in chronic cough. The dial-in numbers are (888) 415‑4305 for domestic callers and (646) 960‑0336 for international callers. The access code is 5858366. A live webcast of the conference call will be available on the Investor Relations page of the company’s website at https://ir.aldeyra.com. After the live webcast, the event will remain archived on the Aldeyra Therapeutics website for 90 days.
About Aldeyra
Aldeyra Therapeutics is a biotechnology company devoted to discovering innovative therapies designed to treat immune-mediated diseases. Our approach is to develop 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 product candidates include RASP (reactive aldehyde species) modulators ADX‑629, ADX‑246, ADX‑248, and chemically related molecules for the potential treatment of systemic and retinal immune-mediated diseases. Our pre-commercial product candidates are reproxalap, a RASP modulator for the potential treatment of dry eye disease (under U.S. Food and Drug Administration New Drug Application Review) and allergic conjunctivitis, and ADX-2191, a novel formulation of intravitreal methotrexate for the potential treatment of proliferative vitreoretinopathy and retinitis pigmentosa.
SOURCE: Aldeyra Therapeutics
Post Views: 198
- Relative to Placebo, Statistical Significance Achieved for Reduction in Awake Cough Frequency (P=0.01), 24‑Hour Cough Frequency (P=0.001), Awake Cough Count (P=0.001), and 24‑Hour Cough Count (P=0.001)
- ADX-629 Was Well Tolerated and No Safety Concerns Were Identified
LEXINGTON, MA, USA I June 27, 2023 IAldeyra Therapeutics, Inc. (Nasdaq: ALDX) (Aldeyra), a biotechnology company devoted to discovering and developing innovative therapies designed to treat immune-mediated diseases, today 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. The clinical trial demonstrated statistically significant reduction in cough frequency following administration of ADX‑629 relative to placebo.
“Consistent with previously demonstrated activity in clinical trials of patients with psoriasis, asthma, and COVID-19, the reduction in cough frequency observed in the Phase 2 clinical trial in chronic cough supports the potentially broad-based activity of ADX‑629 as a novel, immune-modulating therapeutic approach,” stated Todd C. Brady, M.D., Ph.D., President and CEO of Aldeyra. “We look forward to discussing the results with regulatory authorities as we consider the expansion of clinical testing to include patients with co-morbid conditions of frequent coughing and active inflammation.”
The multicenter, randomized, double-blind, placebo-controlled, two-period Phase 2 crossover trial enrolled 51 patients with refractory or unexplained chronic cough, which is often defined as a cough that persists for more than eight weeks and is unresponsive to treatment. Patients were randomized to receive ADX-629 or placebo twice daily for 14 days, followed by a 14-day washout period prior to crossing over to 14 days of treatment with ADX‑629 or placebo, whichever was not received in the first period. The primary endpoint of the clinical trial was safety. Secondary endpoints included awake cough frequency (the key secondary endpoint), 24-hour cough frequency, quality of life, and clinical impression scales.
Fifty-one patients were enrolled, and all patients completed both treatment periods. 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 following administration of either ADX‑629 or placebo. No serious adverse events were reported, adverse event frequencies were similar across treatment groups, and no patients discontinued due to adverse events.
“Frequent coughing, which is characteristic of a number of inflammatory pulmonary diseases, represents a persistently disturbing condition for patients,” stated Gary N. Gross, MD., Clinical Professor of Internal Medicine at Southwestern Medical School and a Board-certified allergist and immunologist with the Dallas Allergy & Asthma Center. “The difficulty in treating chronic coughing highlights the medical need for new therapies.”
Consistent with a Phase 1 clinical trial and the Phase 2 clinical trial in psoriasis, improvement in LDL and HDL levels was observed following treatment with ADX‑629 relative to treatment with placebo. ADX‑629, an investigational new drug, is a novel, orally administered RASP (reactive aldehyde species) modulator for the potential treatment of systemic immune-mediated diseases. ADX‑629 is also currently in development for atopic dermatitis, idiopathic nephrotic syndrome, and Sjögren-Larsson Syndrome. Initial results from each trial are expected in the second half of 2023. A Phase 2 clinical trial of ADX‑629 in moderate alcohol-associated hepatitis is expected to initiate in the second half of 2023.
Conference Call & Webcast Information
Aldeyra will host a conference call at 8:00 a.m. ET today to discuss top-line results of the Phase 2 clinical trial of ADX‑629 in chronic cough. The dial-in numbers are (888) 415‑4305 for domestic callers and (646) 960‑0336 for international callers. The access code is 5858366. A live webcast of the conference call will be available on the Investor Relations page of the company’s website at https://ir.aldeyra.com. After the live webcast, the event will remain archived on the Aldeyra Therapeutics website for 90 days.
About Aldeyra
Aldeyra Therapeutics is a biotechnology company devoted to discovering innovative therapies designed to treat immune-mediated diseases. Our approach is to develop 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 product candidates include RASP (reactive aldehyde species) modulators ADX‑629, ADX‑246, ADX‑248, and chemically related molecules for the potential treatment of systemic and retinal immune-mediated diseases. Our pre-commercial product candidates are reproxalap, a RASP modulator for the potential treatment of dry eye disease (under U.S. Food and Drug Administration New Drug Application Review) and allergic conjunctivitis, and ADX-2191, a novel formulation of intravitreal methotrexate for the potential treatment of proliferative vitreoretinopathy and retinitis pigmentosa.
SOURCE: Aldeyra Therapeutics
Post Views: 198
