Clinical Trials

HERACLES - AUTOIMMUNE DISEASE

The HERACLES (for ‘Harnessing Endogenous Regulators Against CLE Study’) trial is taking place in Australia to capitalise on Australian expertise in lupus research and early phase clinical trials.

It is the first-in-human trial of SOF-SKN™, a novel drug candidate for autoimmune diseases, and aims to provide initial safety and pharmacokinetic data for the skin disease that is caused by cutaneous lupus erythematosus (CLE).

As part of an incremental and cost-effective approach, HERACLES is a high-potential, low-risk study focusing on safety and dose finding in healthy volunteers.

The trial has been designed to be easily implemented and rapid. The first safety readouts are expected to be available four to six weeks after dosing has finished, while a comprehensive data analysis should be completed shortly thereafter.

Lupus is most often diagnosed in young adults aged 15 to 45 years of age. Currently, there is no cure for cutaneous lupus and treatment of symptoms is usually required on an ongoing basis, usually for life, representing a significant commercial opportunity for any effective medication.

Download the HERACLES clinical trial pdf here

EXPERIENCED TEAM 

The Noxopharm team has extensive clinical trial experience across Australia, the US and Europe, and has conducted multiple clinical trials in leading hospitals across these jurisdictions.  

Noxopharm holds expertise in clinical trial protocol development, the securing of prestigious hospital study sites and investigators, and the implementation and analysis of clinical trials in both oncology and inflammation.

To date, Noxopharm has managed clinical trials in 33 sites globally, and has secured three orphan drug designations (ODDs) in the US and Europe.