Clinical Trials

HERACLES - AUTOIMMUNE DISEASE

Scheduled to start in 2025, the HERACLES (for ‘Harnessing Endogenous Regulators Against CLE Study’) trial will take place in Australia to capitalise on Australian expertise in lupus research and early phase clinical trials.

It will be the first in-human trial for 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 will be 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 within six weeks after the readouts.

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.

Orphan drug status is granted by the US FDA or the European Medicines Agency (EMA) to drugs that show promise in treating less common diseases.

An ODD confers the following benefits:

• Orphan Drug Exclusivity (ODE) provides seven to 10 years of market exclusivity
• Waiver of New Drug Application fees (in the US this was valued at approximately $2.9 million in 2021)
• Opportunities for grant funding
• Regulatory guidance and assistance from the FDA / EMA with the drug development process

IONIC

A Phase-1 investigator initiated study sponsored by Professor Paul de Souza, combining Veyonda® (idronoxil) with the Bristol Myers Squibb checkpoint inhibitor (CI) Opdivo® (nivolumab) for the treatment of a range of solid tumour types.

Noxopharm has supplied all Veyonda required to support the participating patients, and no further costs for the trial are being incurred by the company from January 2024 onwards.