LEXINGTON, MA, USA I July 24, 2018 I Aldeyra Therapeutics, Inc. (NASDAQ: ALDX) (Aldeyra), a biotechnology company devoted to development of next-generation medicines to improve the lives of patients with immune-mediated diseases, today announced that the first patient has enrolled in a pivotal Phase 3 clinical trial of topical dermal reproxalap for the treatment of ichthyosis (scaly, thickened, dry skin) associated with Sjögren-Larsson Syndrome (SLS).
“There is currently no FDA-approved therapy for the patients suffering from SLS, a rare inborn error of metabolism that leads to severe skin and neurological disease,” commented Todd C. Brady, M.D., Ph.D., President and CEO of Aldeyra. “Based on the positive results from our Phase 2 clinical trial, which demonstrated consistent improvement in the dermatologic manifestations of SLS, we are pleased to enroll our first subject in the Phase 3 clinical trial as part of our ongoing commitment to develop a targeted therapy for SLS patients and their caregivers.”
In August 2016, Aldeyra announced that the results of a randomized, parallel-group, double-blind, vehicle-controlled clinical trial in SLS demonstrated clinically relevant activity in diminishing the severity of ichthyosis. As assessed by central review, five of six drug-treated subjects (83%) achieved a rating of “almost clear” or “mild” on global assessment. Six of six (100%) drug-treated subjects improved over the course of therapy as assessed by central review (p < 0.05), and the improvement was greater than that observed in vehicle-treated patients (p < 0.05). For drug-treated subjects, mean reductions in ichthyosis severity were greater after eight weeks of therapy than after four weeks of therapy, suggesting disease modifying activity.
The randomized, double-blind, multi-center, parallel-group Phase 3 clinical trial is expected to be performed in two parts: the first part of the trial will assess six months of treatment in select areas of ichthyosis over increasing proportions of body surface area; the second part of the trial is expected to assess six months of treatment in all areas of ichthyosis. Data generated from the first part of the trial will be used to confirm statistical power for the second part of the trial. The primary endpoint for the second part of the trial will be improvement in ichthyosis in drug-treated patients over six months of therapy.
A clinical trial synopsis can be found on clinicaltrials.gov (#NCT03445650).
About Aldeyra Therapeutics
Aldeyra Therapeutics is developing next-generation medicines to improve the lives of patients with immune-mediated diseases. Aldeyra’s lead product candidate, reproxalap, is a first-in-class treatment in late-stage development for dry eye disease and other forms of ocular inflammation. The company is also developing other product candidates for autoimmune and metabolic diseases. None of Aldeyra’s product candidates have been approved for sale in the U.S. or elsewhere.
About Sjögren-Larsson Syndrome
Sjögren-Larsson Syndrome is a rare inborn error of metabolism caused by mutations in fatty acid aldehyde dehydrogenase, leading to ichthyosis (scaly, thickened, dry skin), neurological disorders, and retinal disease. No therapy for SLS has been approved by the U.S. Food and Drug Administration. Aldeyra’s RASP (reactive aldehyde species that are pro-inflammatory) inhibitor platform sequesters aldehydes, and thus represents a novel, mechanistically directed therapeutic approach in SLS.
SOURCE: Aldeyra Therapeutics
Post Views: 509
LEXINGTON, MA, USA I July 24, 2018 I Aldeyra Therapeutics, Inc. (NASDAQ: ALDX) (Aldeyra), a biotechnology company devoted to development of next-generation medicines to improve the lives of patients with immune-mediated diseases, today announced that the first patient has enrolled in a pivotal Phase 3 clinical trial of topical dermal reproxalap for the treatment of ichthyosis (scaly, thickened, dry skin) associated with Sjögren-Larsson Syndrome (SLS).
“There is currently no FDA-approved therapy for the patients suffering from SLS, a rare inborn error of metabolism that leads to severe skin and neurological disease,” commented Todd C. Brady, M.D., Ph.D., President and CEO of Aldeyra. “Based on the positive results from our Phase 2 clinical trial, which demonstrated consistent improvement in the dermatologic manifestations of SLS, we are pleased to enroll our first subject in the Phase 3 clinical trial as part of our ongoing commitment to develop a targeted therapy for SLS patients and their caregivers.”
In August 2016, Aldeyra announced that the results of a randomized, parallel-group, double-blind, vehicle-controlled clinical trial in SLS demonstrated clinically relevant activity in diminishing the severity of ichthyosis. As assessed by central review, five of six drug-treated subjects (83%) achieved a rating of “almost clear” or “mild” on global assessment. Six of six (100%) drug-treated subjects improved over the course of therapy as assessed by central review (p < 0.05), and the improvement was greater than that observed in vehicle-treated patients (p < 0.05). For drug-treated subjects, mean reductions in ichthyosis severity were greater after eight weeks of therapy than after four weeks of therapy, suggesting disease modifying activity.
The randomized, double-blind, multi-center, parallel-group Phase 3 clinical trial is expected to be performed in two parts: the first part of the trial will assess six months of treatment in select areas of ichthyosis over increasing proportions of body surface area; the second part of the trial is expected to assess six months of treatment in all areas of ichthyosis. Data generated from the first part of the trial will be used to confirm statistical power for the second part of the trial. The primary endpoint for the second part of the trial will be improvement in ichthyosis in drug-treated patients over six months of therapy.
A clinical trial synopsis can be found on clinicaltrials.gov (#NCT03445650).
About Aldeyra Therapeutics
Aldeyra Therapeutics is developing next-generation medicines to improve the lives of patients with immune-mediated diseases. Aldeyra’s lead product candidate, reproxalap, is a first-in-class treatment in late-stage development for dry eye disease and other forms of ocular inflammation. The company is also developing other product candidates for autoimmune and metabolic diseases. None of Aldeyra’s product candidates have been approved for sale in the U.S. or elsewhere.
About Sjögren-Larsson Syndrome
Sjögren-Larsson Syndrome is a rare inborn error of metabolism caused by mutations in fatty acid aldehyde dehydrogenase, leading to ichthyosis (scaly, thickened, dry skin), neurological disorders, and retinal disease. No therapy for SLS has been approved by the U.S. Food and Drug Administration. Aldeyra’s RASP (reactive aldehyde species that are pro-inflammatory) inhibitor platform sequesters aldehydes, and thus represents a novel, mechanistically directed therapeutic approach in SLS.
SOURCE: Aldeyra Therapeutics
Post Views: 509
