Gastrointestinal diseases specialist Anatara Lifesciences (ASX: ANR) is expanding recruitment for the Stage 2 of its pivotal GaRP-IBS (Irritable Bowel Syndrome) trial to two new geographical locations and on the overall trial progress.
The company’s focus is on completing the recruitment for Stage 2 in Q4 CY2024 and, as previously advised on 30th August 2024, has added two additional locations to broaden participation reach.
Recruitment has been underway since late last month (September) in Adelaide at SAHMRI located on North Terrace in the city’s health precinct and on Queensland’s Sunshine Coast at the CDHRI, which is a specialist centre focused on gastrointestinal health issues.
This extends the trial reach by providing access to participation in new locations, which has been done to ensure the momentum of the trial continues through to target recruitment levels that allow statistical analysis.
Strong interest continues across the existing sites situated at the Royal Melbourne Hospital and Oztrials in Drummoyne (Sydney) and there seems a similar level of community interest around the sites in Adelaide and Maroochydore, with participants already in screening at both new sites.
“The additional trials sites provide the opportunity for IBS sufferers in further geographical locations to participate and will bolster enrolment to ensure adequate numbers through Stage 2 in the required time frame,” Executive Chair, Dr. David Brookes, said.
“We were encouraged by the eagerness of these new sites to be involved in the trial of our GaRP product as potentially an emerging treatment for a difficult medical condition and also by their empathy for the participants, given the GaRP-IBS trial criteria includes only moderate to moderately-severe sufferers by international classification in the IBS sub-types D (diarrhoeal predominate) and M (mixed). “
Following the trial protocol screening processes that are consistent with Stage 1 of the trial, enrolments had reached 36 participants in Stage 2 of the trial at the end of last week, some of whom have completed the treatment phase.
A further group of approximately 20 participants are currently in final screening to determine suitability to enter the trial and a much larger group of potential participants, identified as potentially eligible from the initial questionnaires, are being followed up to determine suitability to be offered enrolment screening.
The target participant number is 60-100 for Stage 2 of the GaRP-IBS trial as per the design.
