Imaging Biometrics, a subsidiary of IQ-AI Ltd, has recently made a significant announcement regarding its lead drug candidate, IB-003. The US Food and Drug Administration (FDA) has granted Rare Pediatric Disease Designation (RPDD) to IB-003, marking a crucial milestone in the development of potential treatment for atypical teratoid rhabdoid tumors (ATRT).
ATRT is a rare and aggressive tumor that primarily affects children, with limited treatment options and poor outcomes. The FDA defines rare pediatric diseases as serious conditions that impact fewer than 200,000 individuals under 18 years old in the US. This makes the designation of RPDD for IB-003 particularly important in addressing the unmet clinical needs of children with ATRT.
IB-003 is an oral formulation of gallium maltolate (GaM) that has shown promising results in both pre-clinical and clinical trials for brain tumors. One pre-clinical study conducted at the Medical College of Wisconsin revealed significant growth inhibition of ATRT tumors and improved survival rates. Specifically, the median survival rate increased from 89 days in the control group to 170 days in the group treated with IB-003.
The RPDD for IB-003 not only highlights the potential impact of the drug on treating ATRT but also presents additional opportunities for Imaging Biometrics. If IB-003 receives market approval under the RPDD, Imaging Biometrics may qualify for a priority review voucher (PRV). This voucher can be utilized to expedite the review of future marketing applications or traded to other pharmaceutical companies.
Trevor Brown, the chief executive of IQ-AI, expressed the significance of receiving the RPDD from the FDA. He emphasized the importance of addressing the unmet medical needs of children with ATRT and acknowledged the RPDD as a critical milestone in the planning and development of IB-003.
In conclusion, the RPDD granted to Imaging Biometrics’ lead drug candidate, IB-003, signifies a significant step forward in the potential treatment of ATRT. With promising results from pre-clinical and clinical trials, IB-003 offers hope for improved outcomes for children battling this rare and aggressive tumor.
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