Anatara Lifesciences provided an update on the Gastrointestinal ReProgramming(GaRP) trial for IBS . The Company to advise that the trial momentum and enrolment is now essentially consistent with the previous guidance after the anticipated and managed delay to recruitment and randomisation from mid-December over the Festive Season. This was somewhat protracted by further slight delays due to resolution of administrative matters at trial sites that followed from the ethics approval of the new modified protocol.

Recruitment was only minimally impacted by the administrative delays and the Company is very pleased to advise that enrolment and randomisation onto product and placebo began again last week with 9 new participants subsequently in the enrolment and randomisation steps. The total of enrolled participants will now be approximately 50, influenced by an anticipated variable withdrawal rate. As per previous advice, the company noted there have been no significant tolerance or safety issues to date and that, with respect to the withdrawal consideration, one-third of participants are randomised to placebo.

The new "GaRP" trial criteria for IBS (Irritable Bowel Syndrome excluding only the constipation subset) and the focus on addressing screen failure inconsistencies that became apparent has led to increased interest in participation and a higher enrolment rate. From the recruiting process that resumed immediately after the Festive season break, there is a significant number of prospective participants readied for the enrolment process and the recent momentum is anticipated to be ongoing through to completion of Stage 1 recruitment. Apart from modifying the GaRP trial criteria, the Company engaged the ProPharma Group to act as the principal clinical research organisation towards the end of CY2022.

Effectively Anatara has installed a new team and internal supervisory process for the ongoing trial. The current recruitment rate and reinforcement will likely result in the interim analysis becoming available in early Third Quarter CY2023 when 90 participants remaining involved is reached, slightly later than previously indicated. The recruitment for Stage 1 is expected to be complete in early 2Q2023.

Importantly the budget has not been significantly impacted by this time variation.