Aldeyra Therapeutics Inc (NASDAQ:ALDX), which happens to be a clinical-stage biotech company that is much dedicated to treating health complications ideally related to endogenous aldehydes, which is as a matter of fact a naturally occurring class of pro-inflammatory toxic substances has today cleared the air around the most important matter.
In making a statement, it revealed that indeed the United States Food and Drug Administration (FDA) had granted Aldeyra’s novel compound ADX-102 orphan drug designation that would see it completely face out congenital ichthyosis, which is a serious and defective skin condition characteristic of Sjögren-Larsson Syndrome (SLS) that a lot of patients have lately been struggling with.
At this particular moment, there are no FDA-approved therapies specifically targeting the treatment of ADX-102 and SLS. According to some top experts, ADX-102 has showcased great abilities as an SLS therapy in clinical development.
The President who is at the same time the CEO of Aldeyra while making a statement said, “The skin disease associated with SLS is physically and emotionally debilitating culminating to considerable social stigma and requiring significant daily care and medical resources. Receipt of orphan drug designation by the FDA is great step forward for both Aldeyra and patients struggling with this rare and difficult-to-treat disease.”
As a matter of fact, SLS results from genetic mutations which are widely known to actually lead to heightened levels of toxic aldehydes. In August of 2016,the top provider went ahead to make an announcement citing that ADX-102 in a great way helped improve ichthyosis in SLS patients in a randomized and double-blind, vehicle-controlled Phase 2 clinical trial, an instance that had ADX-102 administered to skin for some two consecutive months.
The exercise was a great success, revealing a major improvement from the baseline. The results obtained were as a matter of fact statistically as well as clinically significant not leaving behind the fact that indeed magnitude of improvement came out being statistically superior to the vehicle treatment one.
A worldwide double-blind, pivotal Phase 3 study is much anticipated and is set to take place in the later part of this particular year. Patients around the globe look forward to the very best, but whatever awaits them in the future is something we just have to wait and see!
