Anatara Lifesciences (ASX:ANR) has announced that it has voluntarily terminated the third efficacy study in Australia, announced on 16 June 2016, for its lead product, Detach, a non-antibiotic, natural therapeutic for the control of diarrhoea in piglets.
"Unusual, extreme conditions including power and water shortages encountered at the trial site and unrelated to the trial necessitated the removal of 22% of sows and 25% of piglets from the study, with limited ability to enrol further pigs," said the company.
"Given the removal of the animals from the trial will make it very difficult to achieve statistical significance of results in accordance with the trial protocol, Anatara took the proactive decision to terminate the study, effective immediately," it added.
The company said the trial termination does not impact its ability to submit its dossier required for the Australian Pesticides and Veterinary Medicines Authority’s (APVMA) product registration process as planned in Q3 2016.
"The objective of this third efficacy study was to expand the dosing instructions for the final registration label, however the original, single dose regimen which was proven to be effective in earlier trials will be sufficient for the AVPMA dossier," it said.
Anatara Chief Scientific Officer, Dr Tracey Mynott, said: “Although we made the decision to terminate the efficacy study early, Anatara’s plans to submit the dossier for Detach to the APVMA in Q3 this year remain unchanged. This particular trial was not pivotal to our APVMA submission, and does not impact our forward launch plans”.
Anatara Chairman, Dr Mel Bridges, commented, “Anatara still expects approval for Detach and product launch in Australia in 2017. Due to circumstances outside of our control, it was not feasible to continue this study. The voluntary withdrawal from this farm site is unfortunate, however it does not in any way impact our path to continuing to delivering on our key milestones. I can only stress in the strongest terms – we remain on track”.
The company said its earlier announced, separate target animal safety (TAS study), which aims to provide detailed safety data on Detach, continues as planned.