Nitric oxide is a natural molecule that is produced by and is essential to the biological functions of the human body. It acts as a signalling molecule for a range of cellular responses, and has powerful anti-inflammatory, anti-microbial, and vasoregulatory effects.¹
As a free radical, nitric oxide is quick to react when it comes into contact with other compounds and has a lifespan of only a few seconds. By extension, among the greatest challenges of developing this molecule as an active drug substance is the creation of a delivery system that can control its release locally and its interactions with reagents.²
SynDermix holds a proprietary hydrogel formulation, SDX-21, which enables the sustained release of nitric oxide by the donor compound S-Nitrosoglutathione (GSNO).
The innovative step of the technology is in the composition of the GSNO formulation, with polysaccharide-type polymers, which are capable to stabilise the otherwise highly labile GSNO, and in a specific pH range, which further improves its stability.
The formulation, intended to be applied with the use of a medical device, can release nitric oxide locally over various periods of time and is in development for the treatment of a number of disorders.
With this mechanism of action, SDX-21 has the potential to prolong skin exposure to the therapeutic activities of the molecule without the risks associated with nitric oxide excess.
Our strategic objectives regarding our nitric oxide platform are to achieve clinical proof of concept in different indications (such as wounds, infections and painful neurological disorders) and to partner the asset for further development and commercialisation.
SynDermix has recently completed a series of successful feasibility studies on the technology, and recently optimised the formulation and identified suitable medical devices for its application. The initiation of a non-clinical programme involving SDX-21 is expected in Q1 2021.