Brisbane-based Anatara Lifesciences (ASX:ANR) has announced the successful completion of its pivotal Target Animal Safety (TAS) Study for Detach, the company’s lead product for the control of diarrhoea in piglets.
The objective of the study was to provide detailed safety data on Detach when administered to piglets at dose rates higher and more frequent than the recommended dose.
The company said the study involved 40 piglets and Detach was found to be safe when administered orally at the recommended dose rate (2 mL) and also at three times (6 mL) and five times (10 mL) the recommended dose.
Detach was dosed on six occasions (at 2, 5, 9, 12, 15 and 18 days of age) throughout the study, a frequency which far exceeds the recommended dosing regimen.
"There were no differences between placebo-control piglets in any of the parameters studied, including body weight gain, tissue weights, tissue histopathology examination, haematology, serum chemistry, and urine analysis," said the company.
Anatara said the study was a fully GLP compliant, randomised, controlled, parallel group study conducted in accordance with the US Food and Drug Administration’s Center for Veterinary Medicine’s Guideline 185, VICH2 Topic GL43 guideline.
It was contracted to a leading international contract research organisation that provides pre-clinical and clinical services to the global animal health industry.
Anatara CSO, Dr Tracey Mynott, said: “These studies complete the clinical trials component of the APVMA Dossier.
“Although Detach had already been proven safe in previous trials, a formal safety assessment is a requirement for registration of new active ingredients and new veterinary formulations in Australia, Europe and the USA. The results confirm that Detach™ is safe, consistent with the large safety database already generated on the product.
Anatara CEO and Chairman, Dr Mel Bridges, said: “The results of this study, are as we expected, and are a significant milestone achieved in the Detach development program. We continue to make good progress towards the approval of this important product.
"The TAS study was conducted to the highest international standard acceptable in major commercial territories and may reduce the need for separate TAS studies in each jurisdictional registration application. Long term this strategy presents the most efficient and cost effective way to prepare for the global roll out of Detach.”