Noxopharm Ltd (ASX:NOX, OTC:NOXOF) has reached a major drug development milestone in scaling up production of its preclinical SOF-SKN™ lupus medication by 100-fold to the international quality standards required for its upcoming regulatory submissions.
The more stringent regulations will involve manufacturing and testing performed under international Good Laboratory Practice (GLP) standards. These stringent standards are needed to assure the quality and integrity of preclinical data, especially safety data, bringing it up to pharmaceutical grade levels ahead of submissions to key regulators before testing in patients.
Noxopharm has selected an optimised lead drug candidate and is accelerating the project through a 100-fold increase in the amount of drug being produced under GLP standards. The drug will then be used within GLP-accredited laboratories to conduct several regulatory safety studies in the coming weeks and months.
"Great confidence"
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.”
Optimising dosing & collaborations
Noxopharm has also commenced work on formulation and optimal dosing to maximise SOF-SKN’s efficacy and tolerability in patients with autoimmune disease.
It has engaged with a range of experts specialising in the supply of pharmacopeia-compliant materials and reagents for synthesis and formulation, as well as experts in quality control to ensure that manufacturing of the active ingredient and formulated drug takes place according to set specifications.
The company is also collaborating closely with specialists to test the formulated drug in a range of in vitro and in vivo models to further refine the characteristics of the formulated drug and dose. Importantly, each of these tasks is being performed to GLP standards.
Its experienced team, rigorous prioritisation and a sharp focus on core regulatory requirements has seen the company achieve these milestones in an expedited fashion.
Large market for SOF-SKN™
Autoimmune diseases are illnesses that make the body mistakenly attack itself and lupus is just one of a wide range of these diseases that affect millions of people worldwide.
Estimates of the number of individuals suffering from autoimmune diseases in the US alone range from 14 to 24 million cases and the global immunology market is projected to grow from US$92 billion in 2021 to US$158 billion in 2028.
Lupus is most often diagnosed in those aged 15 to 45 years of age. 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.
This presents a large global market for SOF-SKN™ with a need for lifelong treatments.