Anatara Lifesciences opens GaRP therapy trial extension to treat irritable bowel syndrome
Anatara Lifesciences (ASX: ANR) is inviting members of the public to register their interest in Stage 2 of a pivotal Phase II Australian clinical trial of their gastrointestinal reprogramming (GaRP) product in the treatment of irritable bowel syndrome (IBS).
The company anticipates strong interest in the double-blind trial to be conducted at five sites in Melbourne, Sydney and Brisbane following completion of the ethics approval process.
Up to 100 participants will be randomised equally into two groups to take either the optimum dose of the GaRP product selected from Stage 1 of the trial or a placebo.
It is expected that each patient will take approximately three months to complete the trial, which will involve a “wash-out” period (where no treatment is received) followed by eight weeks on GaRP with periodic reporting.
Planned extension
Stage 2 is a planned extension following Stage 1 of the Phase II trial that involved 61 patients and reported a greater than 50% reduction in IBS symptoms.
It aims to confirm the “highly encouraging and clinically meaningful” findings from Stage 1.
Some established inclusion and exclusion protocols that were modified during Stage 1 are expected to enable efficient onboarding of trial participants and facilitate the execution of Stage 2 on time and budget.
Complementary medicine
Anatara’s GaRP product is a multi-component, multi-coated complementary medicine designed to address underlying factors associated with chronic gastrointestinal conditions such as IBS and inflammatory bowel disease.
It is designed to assist in the restoration and maintenance of the gastrointestinal tract lining as a barrier and aid in the homeostasis of gut microbiomes.
Anatara said its trial results to date have signalled a “promising new era” in the quest to alleviate the burdens of IBS and related disorders.
Confirmation of the results will provide the desired evidence-based claim to distinguish GaRP as an IBS treatment and give Anatara a foundation to engage with global pharmaceutical companies keen to take on the complementary medicine.
“Negotiations are in progress with potential partners interested in delivering a new, safe and effective treatment for IBS into a market which currently has a high unmet need,” the company said.
Other opportunities
Anatara is also assessing other opportunities in the human healthcare space and appraising projects suitable to add to its portfolio.
The company is in discussions for the potential use of its established products and know-how for applications in animal health.