OzStar Therapeutics

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Health Professionals
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Product innovation

We have discovered a new treatment for type 2 diabetes mellitus (T2DM), comprising a specific Prebiotic product (designated OZ101) that synergizes with
the sulfonylurea anti-diabetes drugs. While intake of sulfonylurea exclusively controls blood glucose levels, adjunctive consumption of our patented prebiotic
OZ101 results in amelioration of major side effects of sulfonylurea (i.e. weight gain and hypoglycemia) and boosts duration and strength of its

Problem with currently available anti-diabetes treatments

The currently marketed anti-diabetes drugs generally have major side effects and limited efficacy, necessitating multiple drugs to control most patient’s
glycemia. Due to the intake of multiple drugs, each of which having their own side effects, and the progressive nature of the disease, treatment for diabetes
is often inadequate and poses major challenges. T2DM patients often end up on insulin, which is expensive and can lead to serious side effects.

In countries where majority of T2DM patients reside, diagnosed patients are often initially prescribed with a snulfonylurea that have been in wide use for over
50 years. However, many patients taking snulfonylurea experience side effects such as increased risk of
hypoglycemia and weight gain and loss of
efficacy within 6-12 months. We’ve hypothesized that snulfonylurea side effects and loss of efficacy is due to its previously unrecognized
properties because snulfonylurea are derivatives of sulfonamide antibiotics (Sulfa drugs). sulfonylurea side effects occur due to their chronic intake and
inadvertent reduction in patient’s Essential Gut Good Bacteria.

Solution provided

Adjunctive intake of our patented prebiotic OZ101 in combination with all snulfonylurea class of anti-diabetes drugs will restore patient’s Essential Gut Good
Bacteria, which in turn will significantly ameliorate snulfonylurea’s major side effects and will prolong its efficacy. The resultant combination treatment will
sustain near-normal blood glucose levels for several years without the need for a dose change or intake of other anti-diabetes drugs.

About prebiotic OZ101

OZ101 tablet composed of plant-derived water extracted natural carbohydrate that has been given Generally Recognised As Safe (GRAS) status by the
USFDA, TGA, EMEA and other major regulatory authorities. OZ101 will be marketed as a "
Medical Food" and must be used under a physician supervision.

The term medical food, as defined in section 5(b) of the Orphan Drug Act (21 U.S.C. 360ee (b) (3)) is "a food which is formulated to be consumed or
administered enterally under the supervision of a physician and which is intended for the specific dietary management of a disease or condition for which
distinctive nutritional requirements, based on recognized scientific principles, are established by medical evaluation."

Advantage of OZ101

Patients are aware of the long-term health consequences if proper glycaemic control is not achieved and thus patients have a strong desire to improve the
control of their blood glucose levels. They are also aware of the finite use of current diabetes drugs before insulin treatment is required. Therefore,
treatment regimes that improve glycaemic control, eliminate the side effects or extend the efficacy of existing drugs and improve patient well-being will
represent a breakthrough.
Current 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 prebiotic OZ101 and sulfonylurea for the treatment of T2DM. We have commissioned the world-leading clinical research organization,
Clinical, to manage the conduct of this clinical trial. We have designed this 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 adjunctive therapy to
sulfonylurea for glycaemic control in patients with T2DM.  Patients will be recruited whose diabetes has been treated with sulfonylurea monotherapy for the
past 6 months or more but who still exhibit uncontrolled fasting glucose levels (FGL) 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 patients treated with OZ101 plus sulfonylurea and metformin compared to patients treated only with sulfonylurea and

This study will also assess OZ101 adjunctive 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 adjunctive therapy to sulfonylurea. The mechanistic studies will also assess the effects of OZ101 add-on on sulfonylurea absorption and