Australian company Anatara Lifesciences (ASX:ANR) has updated investors on the GaRP-Irritable Bowel Syndrome (IBS) phase 2 trial and the anti-obesity project.
The company said the GaRP-IBS trial has been paused since mid-December 2024, and all participants have completed the mandatory two-week follow-up period after being randomised to receive either a placebo or the GaRP product.
"This is consistent with previous guidance and the usual processes of data lock through to analysis now occurs leading to the announcement of headline results later in March," it said. The trial's primary endpoint is IBS-Severity Scoring System. The secondary endpoints include adequate relief, anxiety and quality of life.
The company said guidance from the preliminary analysis is that the primary endpoint is unlikely to be achieved. It said the secondary endpoint of a greater than 20 per cent improvement in IBS-SSS from baseline appears highly likely to be achieved. Investors responded with the company's share price more than halving.
Anatara executive chair Dr David Brookes said, “The company is obviously extremely disappointed that the preliminary analysis we have reviewed has left little doubt that the statistically significant primary efficacy endpoint that had been our focus from Stage 2 will not be achieved. The final headline results with some secondary endpoints that are expected later in the month will still be of interest, especially as the IBS-SSS is a subjective measure and the trial has the expected high placebo response. Anatara will be endeavouring to maximise the value of the GaRP project, while progressing our exciting anti-obesity concept work.”
The company also provided an update on its anti-obesity project. It said the planned in-vivo pre-clinical experiments that have been approved following ethics submission are now underway following agreements with the University of Newcastle, who will conduct the studies.
"The anti-obesity project has been designed to develop an oral medication to assist weight reduction and sustaining weight control in conjunction with other contemporary treatments and approaches," it said, adding, "Specifically, the product is being developed with the target of assisting the maintenance of weight loss and limiting rebound weight gain following cessation of contemporary weight loss medications."