On Tuesday, August 9, 2016, Aldeyra Therapeutics, Inc. (NASDAQ: ALDX), a biotechnology company involved in the commercialization of products that treat diseases thought to be related to endogenous aldehydes, made public the results of a randomized, parallel-group, double-blind, vehicle-controlled, multi-center clinical trial of topical dermatologic NS2 for the treatment of the dermal manifestations of Sjögren-Larsson Syndrome (SLS). The company, which is based in Lexington, Massachusetts, first became aware of SLS in 2012 and made the decision to employ its knowledge of aldehyde traps to combat the disease. The encouraging conclusion of these clinical trials marks, therefore, a major milestone for Aldeyra in its efforts to develop products that sequester and allow for the degradation of aldehydes.
Announcing the results, Dr. William Rizzo said:
“The results of this randomized and controlled clinical trial represent a significant advance in the effort to develop a treatment for SLS. The data from this trial suggest that NS2, when applied topically to the skin, has the potential to help patients suffering from SLS by lowering toxic aldehyde levels and preventing the dermal dysfunction that causes ichthyosis. I am excited about these results, and I am particularly excited for SLS patients and their caregivers.”
Dr. William Rizzo was the principal investigator of the trial and is a leading expert in SLS. He is a pediatric geneticist attached to the College of Medicine at the University of Nebraska.
SLS is a type of ichthyosis that, in some cases, is accompanied by spasticity and other forms of mental retardation. It is caused by mutations in a gene that normally makes an enzyme called fatty aldehyde dehydrogenase, which is necessary for lipid (fat) metabolism. Ichthyosis is a family of genetic skin disorders characterized by very dry skin that has an appearance like the scales of a fish. The prefix ‘ichthy’ is taken from the Greek root for the word ‘fish’.
NS2 is expected to trap fatty aldehydes that are pathogenic in SLS patients, thereby diminishing the lipid-aldehyde adduct formation that likely results in ichthyosis associated with SLS and, potentially, reducing the mild dermal inflammation characteristic of SLS.
In the studies, conducted at three clinical sites in the U.S., 12 subjects aged 8 to 25 with confirmed SLS and moderate to severe ichthyosis were examined. On a random basis, the 12 were assigned to parallel groups: six to the NS2 1.0% group and another six to the vehicle group. Topical treatments, typically, consist of the active ingredient and other compounds that act as a ‘vehicle’ for the active ingredient. It is possible that the vehicle may itself affect the condition being studied and so a vehicle control group, similar to a placebo group in drug trials, is set up. A double blind study is one in which neither the subjects nor researchers know to whom the substance under test is being administered.
For more information, visit http://ir.Aldeyra.com
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