Imaging Biometrics, a subsidiary of IQ-AI Ltd (LSE:IQAI, OTCQB:IQAIF), has announced that the US Food and Drug Administration (FDA) has granted Rare Pediatric Disease Designation (RPDD) to IB-003.
IB-003 is Imaging Biometrics’ lead drug candidate for treating atypical teratoid rhabdoid tumors (ATRT). it is an oral formulation of gallium maltolate (GaM).
ATRT is a rare, aggressive tumour affecting children, with limited treatment options and poor outcomes. According to the FDA, rare pediatric diseases are serious conditions that affect fewer than 200,000 people under 18 years old in the US
IB-003 has shown promising results in pre-clinical and clinical trials for brain tumours.
A pre-clinical study at the Medical College of Wisconsin demonstrated significant ATRT growth inhibition and improved survival. Specifically, median survival increased from 89 days in the control group to 170 days in the IB-003 treated group.
If IB-003 receives market approval under the RPDD, Imaging Biometrics may qualify for a priority review voucher (PRV), which can be used for expedited review of future marketing applications or sold to other companies.
"Receiving this RPDD from the FDA underscores the unmet clinical need for children with ATRT," said Trevor Brown, chief executive of IQ-AI. "It is another critical milestone in our planning and development of IB-003."