The SAFEGUARD study is a clinical trial of a newly developed disease-modifying therapy for T1D. It’s started recruiting participants at multiple sites in Australia and New Zealand.
What treatment is being tested?
The SAFEGUARD study will evaluate the effectiveness and safety of SAB-142, which is a new form of anti-thymocyte globulin (ATG). ATG has been shown in previous clinical trials to help slow the progression of T1D in people newly diagnosed with the condition.
Earlier versions of ATG had some unwanted side effects, as it wasn’t specific for humans. But SAB-142 is an improved form of ATG that directly targets cells in the human immune system that are involved in destroying the insulin-making beta cells.
The trial is testing whether, by interfering with the immune attack on the beta cells, SAB-142 can protect these cells and their ability to make insulin, with fewer side effects.
Dr Dorota Pawlak, Chief Scientific Officer at Breakthrough T1D Australia, said:
Disease-modifying therapies like ATG that dampen the immune attack on the insulin-making cells are an exciting area of T1D research as they hold the potential to protect residual insulin production in people newly diagnosed with T1D. This new version of ATG has been specifically designed to potentially be a safer therapy to slow the progression of T1D and maintain insulin production with fewer side effects.
Breakthrough T1D is committed to developing, improving and testing disease-modifying therapies until we have a suite of different treatments. These therapies represent an exciting avenue to improving lives for people with T1D and one day even halting the condition altogether.”
Who can take part in this clinical trial?
The researchers running the SAFEGUARD study are recruiting people who have been diagnosed with T1D and started insulin therapy within the last 100 days.
Clinical trial sites are currently open in Melbourne (ages 16-40), Sydney (ages 18-40) and Auckland (ages 18-40), with more sites to open over the coming months in Perth, Brisbane, and New Zealand for children aged 5-17.
Taking part in the SAFEGUARD trial
Participants in the SAFEGUARD study will receive either SAB-142 or a non-active placebo through a vein in their arm in 2 x 4 to 6 hour sessions. This treatment is given once at the beginning of the study and once 6 months later.
Candice Hall, Research Project Manager at the Australasian Type 1 Diabetes Immunotherapy Collaborative (ATIC), said, “Thanks to vital support from Breakthrough T1D, ATIC is supporting enquiries and pre-screening for those interested in participating in the SAFEGUARD trial. Please visit the ATIC website to learn more about this trial and submit an enquiry.”
How is Breakthrough T1D involved?
ATIC is a clinical trials network, which is supported by Breakthrough T1D through the Type 1 Diabetes Clinical Research Network (T1DCRN).
Dr Dorota Pawlak, said: “Breakthrough T1D’s support saw the establishment of ATIC in 2021 with the collaborative transforming the clinical trials landscape in Australia. It provides the necessary infrastructure to enable clinical trials of disease-modifying therapies for T1D to run smoothly and achieve maximum impact.
“We’ve seen fantastic results from the BANDIT trial (which was also run through ATIC) of baricitinib preserving insulin production in T1D and we now hope the SAFEGUARD trial will replicate this success with SAB-142.”
