Anatara Lifesciences on track with recruitment for Stage 2 of GaRP IBS trial
Anatara Lifesciences (ASX: ANR) has reported that recruitment for Stage 2 of its pivotal GaRP (Gastrointestinal ReProgramming) trial for the treatment of irritable bowel syndrome (IBS) is proceeding well and remains on budget.
The company has also confirmed an extension to the recruitment timeline through to August.
Stage 2 of the GaRP trial follows the completion of Stage 1, which involved 61 patients who reported a greater than 50% reduction in IBS symptoms after using patented complementary medicine designed to assist restoration and maintenance of the gastrointestinal tract lining as a barrier and support the homeostasis of the gut microbiome.
High interest
Anatara has experienced high levels of interest at its five GaRP trial sites in Melbourne, Sydney and Brisbane, receiving more than 1,000 recruitment applications.
The company has recruited 18 participants to date for Stage 2 of the trial, some of whom have already completed the treatment phase.
A further group of approximately 20 participants is currently undergoing the screening process to determine their suitability for the trial and a much larger group of potential participants has been identified as eligible based on their responses to initial questionnaires.
Anatara is targeting a maximum of 100 participants for Stage 2 and anticipates reaching this number before the end of September.
Participants will be randomised into one of two arms in the trial and receive either the optimum dose of the GaRP product or a placebo for eight weeks, followed by a 14-day follow-up.
Proceeding to plan
Executive chair Dr David Brookes said Stage 2 was proceeding to plan.
“We are very focused on the completion of this trial and having a headline readout by the end of this calendar year,” he said.
“We believe this is achievable and have contingencies in place should any aspect of the recruitment process need bolstering or support.”
The GaRP trial results to date have signalled a promising new era in the fight to alleviate the burdens of IBS and related disorders.
Confirmation of these results is expected to provide the desired evidence-based claim to distinguish GaRP as an IBS treatment and give Anatara a foundation to engage with global pharmaceutical companies interested in expanding their portfolio of complementary medicines.
The company said discussions were ongoing with potential partners to deliver a new and effective treatment for IBS into a “highly unsatisfied market” and is also securing a supply chain of materials for commercial readiness of the GaRP product.
Financial particulars
Net cash outflow from operating activities during the quarter was $856,000, compared to $384,000 in the previous period, attributable mainly to the initiation of the Stage 2 clinical trial.
Anatara completed a $1 million share placement in May that gained strong support from existing institutional and sophisticated investors.
Director participation of $70,000 was approved by shareholders at an extraordinary general meeting in July.
Anatara had a cash balance of $982,000 as at the end of the period.