Breaking the silence on lupus: Industry, MPs and patients unite to tackle the critical gaps

Medicines Australia, AstraZeneca, and Noxopharm joined the Parliamentary Friends of Autoimmune Diseases event, spearheaded by the patient advocacy group Dragon Claw. Co-chaired by Dr Gordon Reid MP, Dr Sophie Scamps MP, and Jenny Ware MP, this Parliamentary Friends group shed light on the complex challenges faced by Australians living with systemic lupus erythematosus (SLE).

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.

“If you are diagnosed in your early twenties, that is not a great outcome,” said Professor Eric Morand, Director of Rheumatology at Monash Health and Dean of the Sub-Faculty of Clinical and Molecular Medicine at Monash University.

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 Morand.

“The use of new medicines… is now recognised by global treatment guidelines as part of the standard of care, and it is such welcome news that Australian patients now stand to benefit from this breakthrough,” Professor Morand stated.

However, the need for more innovation in lupus treatment remains urgent. Dr Gisela Mautner, CEO of Australian biotech Noxopharm, told Health industry Hub, “We were very proud to be part of the Spotlight on Lupus event at Parliament House in Canberra, which focused on building awareness of this widely misunderstood disease.

“Lupus’ effect on people is profound, and in fact often leads to fatal consequences. It is a disease where there haven’t been any new treatments for many decades and, although this situation has slightly improved recently, there is still a desperate need for new treatments.”

Noxopharm is working to address this need with its first in-human trial for SOF-SKN, a novel drug candidate for autoimmune diseases. Planned to begin by mid-2025, the trial will focus on treating cutaneous lupus erythematosus (CLE) – lupus affecting the skin. As the phase I HERACLES trial progresses, the ASX-listed company plans a seamless transition into a follow-on trial targeting lupus patients across specialist centres in Australia.

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.

Medicines Australia voiced the call for faster access to innovative treatments, emphasising that “urgent, system-wide reform is needed to fix the delays. Implementing the Health Technology Assessment (HTA) Review recommendations is critical to ensuring timely and equitable access to innovative therapies.”

In reimagining healthcare across the entire patient journey, Health Industry Hub^TM is the only one-stop-hub uniting the diversity of the Pharma, MedTech, Diagnostics & Biotech sectors to inspire meaningful change.

The Health Industry Hub^TM content is copyright protected. Access is available under individual user licenses. Please click here to subscribe and visit T&Cs here.