Aussie biotech announces R&D partnership for first in-human trial in lupus

ASX listed biotech company Noxopharm has engaged a highly-regarded Australian phase 1 unit to deliver the upcoming HERACLES clinical trial.

The trial will take place in Melbourne and will be conducted by Doherty Clinical Trials, a specialist not-for-profit organisation established by the Peter Doherty Institute for Infection and Immunity with a particular focus on early phase studies.

Doherty Clinical Trials CEO Dr Andrew Brockway said “We are passionate about the development of new medicines for diseases with unmet medical needs and are excited to support Noxopharm through our extensive knowhow and network of collaborators.”

Noxopharm CEO Dr Gisela Mautner said “We are very pleased to have secured such an outstanding organisation to host the HERACLES trial. The Doherty Clinical Trials team are experts in what they do, and we are looking forward to working closely with them as we take our innovative SOF-SKN drug for lupus into the clinic for the first time.”

The autoimmune disease, lupus, affects an estimated 20,000 Australians, with a higher prevalence among Indigenous Australians, Asians, and other non-European groups. The disease carries a ten-year mortality rate of 10%, a grim statistic.

The challenges for lupus patients have been compounded by the limited treatment options available. In the last 60 years, AstraZeneca’s monoclonal antibody Saphnelo (anifrolumab) has been the only new therapy reimbursed for lupus in Australia.

The intravenous therapy, which was added to the PBS on July 1, 2024, showed a statistically significant and clinically meaningful reduction in disease activity compared to placebo in the global TULIP 2 trial, led by Professor Eric Morand, Director of Rheumatology at Monash Health and Dean of the Sub-Faculty of Clinical and Molecular Medicine at Monash University.

However, the need for more innovation in lupus treatment remains urgent and Noxopharm is working to address this need.

In related news from the World Congress of Nephrology, data from Roche’s phase III REGENCY trial of Gazyva/Gazyvaro (obinutuzumab), an anti-CD20 monoclonal antibody, revealed statistically significant and clinically meaningful improvements in lupus nephritis compared with standard therapy alone. Despite current treatment options, up to a third of people with lupus will develop end-stage kidney disease within 10 years, where dialysis or transplant are the only available options and the risk of mortality is high.

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