Noxopharm (ASX:NOX) is scaling up the production of its preclinical SOF-SKN lupus medication to the standards required for upcoming regulatory submissions.
The company said SOF-SKN has reached the next level of development, meaning that much higher amounts of the drug will need to be manufactured.
Manufacturing and testing are now performed under international Good Laboratory Practice (GLP) standards.
Noxopharm has selected an optimised lead drug candidate and is accelerating the project through a 100-fold increase in the amount produced under GLP standards. The drug will then be used within GLP-accredited laboratories to conduct several regulatory safety studies that will take place in the coming weeks and months.
The company said it has also commenced work on formulation and optimal dosing to maximise SOF-SKN’s efficacy and tolerability in patients with autoimmune disease.
Lupus is most often diagnosed in young adults aged 15 to 45. Treatment of the symptoms is usually required on an ongoing or recurring basis, often for life, representing a significant commercial opportunity for any effective medication.
Noxopharm CEO Dr Gisela Mautner said, “Scaling up to GLP standards demonstrates that we have great confidence in SOF-SKN as a prospective treatment for lupus, based on a large body of robust data. Reaching this checkpoint in the development process increases the potential for external interest in our technology, as well as the asset’s commercial value.
“This is a major step in the drug development process. SOF-SKN has a well-informed timeline in place and is now on a clear path towards formal engagement with regulatory authorities.
“On the big picture level, we see the development of SOF-SKN as the first step on the way to tackling the much larger autoimmune disease market in areas such as rheumatoid arthritis. There is huge potential contained within our Sofra platform pipeline, and we aim to fully exploit that position both now and well into the future.”