OzStar Therapeutics

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Research Focus
Product Innovation

Our patent-protected Generally Recognized As Safe (GRAS) and cost-effective Prebiotic product is given to patients on
sulfonylurea anti-diabetes drugs as an adjunctive ingredient for the treatment
of type 2 diabetes. Clinical case studies on
diabetes patients have revealed that adjunctive intake of our Prebiotic together with sulfonylurea ameliorates clinically significant
side effects of sulfonylurea and extends its effectiveness
.....Read More>>

Problem with currently available anti-diabetes treatments

T2DM is an unmet medical need because 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.

Sulfonylureas are still widely used and their
long-term side effects are well characterized; with nearly half of patients with
T2DM in China, India, Brazil, Japan and Indonesia still being treated with sulfonylurea and about quarter of USA diabetes
patients receive sulfonylurea. This is because sulfonylurea is cheap and deemed sufficiently effective. Thus, in countries where
majority of T2DM patients reside, diagnosed patients are often initially prescribed with a sulfonylurea that have been in wide use
for over 50 years. However, many patients taking sulfonylurea experience side effects such as increased risk of
weight gain and loss of efficacy within 6-12 months. We’ve hypothesized that sulfonylurea side effects and loss of efficacy
is due to its previously unrecognized
antibiotic properties because sulfonylurea are derivatives of sulfonamide antibiotics (Sulfa
). sulfonylurea side effects occur due to their chronic intake and inadvertent reduction in patient’s Essential Gut Good


Adjunctive intake of our patented prebiotic OZ101 in combination with all sulfonylurea class of anti-diabetes drugs may restore
Essential Gut Good Bacteria, which in turn may significantly ameliorate sulfonylurea’s major side effects and may
prolong its efficacy. This is because prebiotic OZ101 is composed of soluble dietary fiber and is a
Good Food for the  
Endogenous Gut Good Bacteria. The resultant combination treatment sustains 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 Recognized 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.

To receive free samples of OZ101 prebiotic, please do not hesitate to contact us at "info@o".
Type 2 Diabetes Mellitus
Diabetes is the fourth leading cause of global mortality by disease. Every year ~5 million diabetic patients die from diabetes
associated complications. T2DM is caused by a combination of insulin resistance and insufficient insulin production. Insulin is a
hormone secreted from pancreatic beta cells and is responsible for removing glucose from the blood to maintain normal blood
glucose levels. When food is digested, glucose is released into the blood stream causing an increase in blood glucose levels.
The increase in glucose triggers insulin secretion to assist with glucose transfer out of the blood. In T2DM, the presence of
insulin resistance requires an increase in insulin to be produced. However, when the pancreatic beta cells fail to produce
sufficient insulin, T2DM patients are unable to lower blood glucose levels back to the recommended level (5.5-7mmol/L).

According to
International Diabetes Federation long term implications of elevated blood glucose include the risk of cardiovascular
disease, kidney damage, loss in vision, lower limb amputation.
Risk factors include family history, unhealthy eating, lack of
exercise and overweight. Diabetes is an old disese and the earliest mention of diabetes was around 1552 BCE.

The number of patients diagnosed with type 2 diabetes increasing in an alarming rate and type 2 diabetes announced as a
pandemic disease by the United Nations. In 2017, the world had at least 425 million diagnosed type 2 diabetes patient,
accounting for over 5.7% of the world population, and is drastically rising.
Currently marketed anti-diabetes drugs
T2DM can be prevented through life style changes but there is no cure. Current treatments for diabetes include anti-diabetes
drugs, the most commonly prescribed forms are metformin and sulfonylureas. Anti-diabetes drugs assist control of blood
glucose levels through a number of different ways. However, their intake may have associated side effects, including:

  • Weight gain
  • Hypoglycaemia (critically low blood glucose levels)
  • Significant congestive heart failure
  • Bone fractures
  • Increased cardiovascular risks
  • Pancreatitis
  • Infection
  • Lactic acidosis
  • Hypersensitivity reactions
  • Low blood pressure
  • Kidney malfunction
  • Cancer

Currently marketed newer oral anti-diabetes drug classes provide moderate glycemic control but may have serious side
effects and high costs, which restrict their use. The long-term use of currently available drugs may cause cancer or failure of
the heart and the kidney. Thus, there is an immediate need for better, safer and ideally cheaper treatments for T2DM.
Advantage of OZ101
Our innovation is based on the discovery that when patients with T2DM
use sulfonylurea therapy in combination with the new OZ101 therapy
the major side effects of sulfonylurea, such as hypoglycaemia and
weight gain, are significantly reduced or eliminated and management of
this chronic disease is greatly improved such that sulfonylurea efficacy
is extended in terms of both strength and duration (from 6-12 months to
over 5 years). This increased duration of efficacy is unusual for
sulfonylurea class of anti-diabetes drugs as demonstrated thorough
conduct of 10 different clinical trials worldwide that illustrated in Figure 5
of a peer-reviewed article published by
(DeFronzo et al. Diabetes Care,
36, Supp 2, S127-S138 (2013). Figure 1 depicts an illustration of the
synergy between sulfonylurea and OZ101.
Based on a number of clinical case studies, competitive advantage of OZ101 is highlighted below.