Innovative biotech company Noxopharm Limited (ASX:NOX) has completed formulation development for its SOF-SKN lupus medication in advance of the upcoming HERACLES clinical trial.
Formulation is a critical step in the drug development process as it represents how SOF-SKN will be administered to participants in the trial, and also supports the efficacy of the drug itself.
SOF-SKN contains a proprietary ultra-short oligonucleotide that binds to specific inflammation sensors in the body to reduce inflammation at its source.
After a systematic and highly streamlined development process, Noxopharm has now finalised a topical formulation that has been specifically designed to deliver therapeutic levels of the drug as deep as the dermis – the layer of skin that contains the specific inflammation sensors targeted by SOF-SKN.
The formulation has several beneficial characteristics, including enabling an even release and delivery of the active drug ingredient into the skin in a consistent manner. It can also deliver sustained concentrations over 48 hours when compared to a number of other formulations that were tested.
As noted in its June 2024 quarterly update, Noxopharm’s Sofra technology platform is attracting international attention and several material transfer agreements (MTAs) with mid-size to multi-billion dollar companies are already in place.
The value of an MTA lies in the fact that it represents an essential step along the path to potential commercialisation. Each of the companies that signed an MTA with Noxopharm is investing its own resources to assess the potential of a number of novel Sofra assets, and a variety of use cases are being explored.
This engagement supports Noxopharm’s innovative approach and opens pathways to commercial opportunities.
“Finalising the SOF-SKN formulation is a major step as we approach our first clinical trial with this innovative technology,” Noxopharm CEO, Dr Gisela Mautner, said.
“The pieces of the puzzle are all falling into place, and we are now moving forward with other HERACLES trial preparations while continuing to showcase the Sofra platform to a wide range of external stakeholders around the world.”
Interest in RNA-related technologies is expanding rapidly following the success of the major COVID-19 vaccines during the recent pandemic, as they have the potential to create much- needed new drugs and other vaccines for numerous diseases. According to Precedence Research, the mRNA market in 2022 was US$40 billion and is expected to reach US$137 billion by 2032 at a compound annual growth rate of 13%. This burgeoning market offers substantial growth potential for Noxopharm’s Sofra platform.
