Clinical Trials

We have initiated activities associated with the conduct of a proof-of-concept clinical trial and has received
approval for the conduct of this trial in Australia and India from Human Research Ethics Committees. This trial will
further strengthen its therapeutic claims on core discoveries concerning the synergy between our tablet OZ101
and sulfonylurea for the treatment of type 2 diabetes mellitus.

We have received our second grant from the
Australian Government to conduct a phase 2 clinical trial using its GMP
manufactured OZ101 tablet in patients on existing sulfonylurea-only or sulfonylurea and metformin anti-diabetes drugs.  

We have commissioned the world-leading clinical research organization,
George Clinical, to manage the conduct of this
clinical trial. We have designed our clinical trial protocol with the assistance of leading experts. This includes consultation with
eminent individuals, who are experts on endocrinology, entero-endocrinology, clinical trial biostatistics, carbohydrate
immunology, microbiology and drug development.  

Phase 2 Clinical Trial Protocol Design Highlights

This clinical trial has been designed to be a proof-of-concept and signal finding study on the efficacy of different doses of
OZ101 as an add-on therapy to sulfonylurea for glycaemic control in patients with type 2 diabetes.  Patients will be recruited
whose diabetes has been treated with sulfonylurea therapy for the past 6 months or more but who still exhibit uncontrolled
fasting glucose levels above 7 mmol/L.  The primary aim of the study will be to examine the trajectories on fasting blood
glucose, post prandial blood glucose levels and HbA1c in patients treated with OZ101 plus sulfonylurea compared to patients
treated only with sulfonylurea or sulfonylurea and metformin.

This study will also assess OZ101 add-on effects on other diabetes markers such as body weight and safety aspects including
mild and severe hypoglycaemia. Other diabetes related markers such as pancreas function and blood insulin levels will also
be assessed to shed light into the mechanism of action of OZ101 add-on therapy to sulfonylurea.  The mechanistic studies will
also assess the effects of OZ101 add-on on sulfonylurea absorption and metabolism.


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