Dia-B Announces Results Of Phase I Human Trial For Type 2 Diabetes Drug ISF402, And Progress Toward Phase II Trials

Main Category: Diabetes
Also Included In: Clinical Trials / Drug Trials
Article Date: 06 Dec 2007 - 2:00 PDT

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Diabetes development company Dia-B Tech Limited (ASX:DIA) announced that based on very encouraging completed Phase I clinical results of its novel drug ISF402, for the treatment of type 2 diabetes, it will commence planning for the Phase II stage of clinical development.

Dia-B has previously announced:

- an excellent tolerability profile for ISF402 in humans with no adverse clinical effects
- that ISF402 has proven oral availability, which contrasts with most peptides that are broken down and destroyed in the stomach
- an assay for the detection of ISF402 in human plasma

Dia-B has now received an interim report analysing the pharmacodynamics and pharmacokinetics of ISF402 in healthy volunteers and patients with type 2 diabetes, which confirms encouraging dose response trends in the key metabolic parameters, plasma insulin and C-peptide (an indicator of insulin release).

Dia-B Chairman, Dr Michael Wooldridge said, "These results in humans are consistent with the extensive work we performed in pre-clinical animal trials. The report shows very encouraging trends to support the continued development of this drug. We are in the process of designing a product development plan to meet the requirements of opening an Investigational New Drug (IND) application with the US FDA to fully comply with the FDA regulatory regime."

The Phase I study design was a single centre, double-blind, one-way pharmacokinetic study in 32 healthy male volunteers (stage A) and 11 subjects with type 2 diabetes (stage B).

In stage A, there were linear dose response trends in the key metabolic parameters, plasma insulin and C-peptide. In stage B, conducted in people with diabetes, there were trends towards lower blood glucose, lower basal C-peptide and higher increases in C-peptide after a standard meal, but these did not reach statistical significance. However, given the small sample size in this study, the absence of statistical significance was not unexpected.

Dr Wooldridge noted, "This will be a specific focus of a much larger Phase II trial. The trends in these key measurements are in the right direction and the Board finds them very encouraging."

Professor Paul Zimmet AO, a co-inventor of ISF402 and Chairman of the Scientific Advisory Board said "Phase I clinical trials are performed primarily to establish the safety and tolerability of a new drug and these objectives were achieved. It is encouraging to see positive trends in insulin and C-peptide and lower blood glucose after a standard meal in some of the patients with type 2 diabetes when given ISF402 compared to placebo. We now look forward to seeing Dia-B perform a larger study at a range of doses to confirm these effects."

"Our earlier analysis of pharmacokinetic data showed rapid absorption of the drug. A large body of research suggests that poor control of post-meal blood sugars is a major risk factor for heart disease in people suffering from diabetes and so rapid absorption of the drug would be a very important benefit of ISF402 therapy," said Professor Zimmet.

Professor Zimmet added, "There are a number of safety concerns with the currently available drugs for treating type 2 diabetes. We are hopeful that ISF402 may mean such concerns become a thing of the past."

Dr Wooldridge said, "Dia-B will look to join a small and elite number of Australian companies that have drugs proceeding to Phase II human trials. We anticipate commencing dosing of patients in late 2008."

About Dia-B Tech:

Dia-B is an Australian publicly listed biotechnology company (ASX:DIA) focused on the development of therapeutics for the treatment of type 2 diabetes and its associated complications. Type 2 diabetes is suffered by 90% of all people with diabetes and essentially occurs when insulin produced in the body does not fully work. Dia-B has three compounds in development:

- ISF402, an orally administered diabetes treatment just completed Phase 1 trials
- IM014 in preclinical development as an insulin sensitiser
- CDA1 in preclinical development for diabetic nephropathy and atherosclerosis

Diabetes is a major metabolic disease now regarded as reaching epidemic proportions in the developed world. In Australia there are real concerns about the likely social and economic burden and this has motivated federal, state and territory governments to agree on a $200 million program to tackle the disease. In the USA more than 20 million people have diabetes representing 7% of the population.

Forward Looking Statements

This press release contains forward-looking statements that reflect the Company's current expectations regarding future events. Forward-looking statements involve risks and uncertainties. Actual events could differ materially from those projected herein and depend on a number of factors including the success of the Company's research strategy, the applicability of the discoveries made therein, the successful and timely completion of clinical studies and the uncertainties related to the regulatory process.

http://www.dia-btech.com.au