Dia-B Tech Limited (ASX:DIA) has achieved a major clinical milestone of its ISF402 diabetes drug development by confirming its detection in the bloodstream of trial patients. Peptides and proteins already existing in the bloodstream often mask small peptide drugs, making drug evaluation unreliable.
A robust procedure has been developed for measuring ISF402 in plasma. Development of the assay has advanced the clinical development of ISF402 by identifying a major clinically active metabolite (HTD-amide) and in animal studies determining the circulating concentrations of HTD-amide that improve insulin action. The assay can measure ISF402 and HTD-amide in plasma from humans and animals dosed orally with ISF402 and the results confirm that ISF402 enters the circulation after oral dosing.
An independently assessed analysis of interim data from the recently completed Phase Ia trial has shown pharmacologically relevant amounts of HTD-amide in plasma from trial subjects dosed orally with ISF402. The concentrations detected were similar to those achieved in rabbits given oral ISF402.
Dia-B chairman Dr Michael Wooldridge stated, “this is a major step in developing the company’s ISF402 diabetes drug. There are usually difficulties in detecting small peptides in the circulation as plasma is full of small peptides and proteins that can mask the signal. It’s like finding a needle in a haystack.”
“Results from the assay demonstrate ISF402 absorption into human plasma after oral dosing, and allows Dia-B to pursue a drug registration strategy with the US FDA.”
Professor Paul Zimmet AO, chairman of Dia-B’s Scientific Advisory Board and Head of the International Diabetes Institute said, “these results add to evidence of good tolerability and safety of ISF402 which is a key competitive advantage for this drug candidate. The need for a new safe diabetes drug has been highlighted by the recent safety concerns of some other drugs used in the treatment of diabetes.”