IQ-AI Ltd on Friday said its subsidiary, Imaging Biometrics LLC, has been granted rare paediatric disease designation by the US Food & Drug Administration for its lead drug candidate, IB-003, or gallium maltolate for the treatment of ATRT.
The medical services firm and parent company of Wisconsin-based healthcare imaging software firm said if market approval for IB-003 is obtained under the RPDD, IB may qualify for a priority review voucher.
ATRT is a ‘highly aggressive’ tumour. There are limited options for children with ATRT, IQ-AI said.
According to IQ-AI, IB-003 has demonstrated ‘promising potential2 in pre-clinical and clinical settings for the treatment of multiple brain tumours.
IQ-AI Chief Executive Officer Trevor Brown said: ’Receiving this RPDD from the FDA underscores the unmet clinical need for children with ATRT. It is another critical milestone in our planning and development of IB-003.‘
Shares in IQ-AI were down 3.0% at 1.60 pence each in London on Friday afternoon.
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