IntraBio Ltd. is pleased to share that the IB1001-202 clinical trial has screened over two-thirds (2/3) the target number of patients.
The study, which investigates N-acetyl-L-leucine (IB1001) for the treatment of GM2 Gangliosidosis (Tay-Sachs and Sandhoff disease), will enroll a total of approximately 30 patients across all international sites. Since recruitment commenced, twenty-three (23) patients have been screened across eight (8) international clinical trial sites.
Recruitment is expected to continue rapidly and be completed by March 2020.
To ensure all patients have the opportunity to participate, interested patients are encouraged to contact their nearest study center as soon as possible to schedule a screening visit before enrollment is complete.
In the United States, three trial sites have been established. Information on each site, including contact details, can be found below.
The Mayo Clinic
Rochester, Minnesota, United States, 55905
Principal Investigator: Dr Anhar Hassan, MD
Contact: Sandra Looney, Clinical Research Coordinator
NYU Langone School of Medicine
New York, New York, United States, 10017
Principal Investigator: Dr Heather Lau, MD
Contact: Sara Rodriguez, Research Coordinator
University of California – Los Angeles
Los Angeles, California, United States, 90095
Principal Investigator: Dr Susan Perlman, MD
Contact: Aaron Fisher, Staff Research Associate Supervisor
IB1001-202 investigates N-acetyl-L-leucine (IB1001) for the treatment of GM2 Gangliosidosis (Tay-Sachs and Sandhoff). This international trial is being run in clinical centers in the United States, the United Kingdom, Germany, and Spain. In the US, patients aged 18 and older with a confirmed diagnosis of GM2 may be eligible for recruitment.
The trial will consist of three study phases: a baseline period, a 6-week treatment period, and a 6-week post-treatment washout period. Patients (and a caregiver) will be reimbursed for reasonable out-of-pocket expenses incurred for participating in the trial, such as travel and parking.
Additional information on Clinical Trial Study IB1001-202 can be found via ClinicalTrials.Gov(NCT03759665).