Australian clinical-stage biotechnology company Noxopharm (ASX:NOX) has announced the administration of the first SOF-SKN dose in the HERACLES trial.
HERACLES is a first-in-human trial for SOF-SKN, a novel drug candidate for autoimmune diseases. The study is evaluating the safety and tolerability of SOF-SKN by testing it at four different concentrations. The study is located in Australia.
The company stated that since obtaining ethics approval, multiple teams have been working on critical tasks to achieve first dosing. These activities include completing regulatory documentation, manufacturing, labelling and shipping the drug, developing and testing a trial-specific database, preparing the site for protocol-specific procedures, and recruiting participants into the trial.
The first part of the trial involves four cohorts, each with four participants, and a schedule of dose increases from one cohort to the next. The first cohort is now receiving the lowest dose, and then a safety steering committee meeting will be held to evaluate the data and determine the next step in the trial.
Noxopharm CEO Dr Gisela Mautner said, “This is a huge milestone for the company as we have taken our first Sofra drug candidate into the clinic at a rapid pace. To our knowledge, this is the first time a molecule that blocks TLR7/8 in a targeted manner has been used topically in humans, which makes it even more exciting.
“The global lupus market is worth more than US$3 billion and is expected to grow significantly over the coming years.”