Proactive Investors - IQ-AI Ltd (LON:IQAI) told investors that its subsidiary, Imaging Biometrics, has received a second US FDA Rare Pediatric Disease Designation (RPDD) for its lead drug candidate, oral gallium maltolate (GaM).
The designation is for the treatment of pediatric-type diffuse high-grade glioma (HGG), a cancer with poor prognosis due to the early dissemination of cancer cells and challenges in surgical resection, it noted.
Such designations provide significant strategic and financial benefits, including eligibility for Priority Review Vouchers (PRVs) which can expedite FDA review processes, or can be sold to other companies.
"This second Rare Pediatric Disease Designation for IB-003 reflects our commitment to address the needs of children affected by these conditions," Q-AI chief executive Trevor Brown said in a statement.
"Building upon these designations, we are exploring ways to accelerate and expand the application of IB-003."
HGG comprises four distinct subtypes as classified by the 2021 World Health Organization (WHO) CNS5. These subtypes are diffuse midline glioma, diffuse hemispheric glioma H3 G34-mutant, diffuse pediatric high-grade glioma H3 wildtype and IDH wildtype, and infant-type hemispheric glioma.
The FDA defines rare pediatric diseases as serious or life-threatening conditions affecting fewer than 200,000 individuals under 18 years of age.
GaM's RPDD follows an earlier designation for the treatment of atypical teratoid rhabdoid tumor (ATRT), leveraging pre-clinical data that showed growth inhibition and extended survival in treated groups.