IQ-AI Ltd (LSE:IQAI, OTCQB:IQAIF) said it is nearing the completion of its phase I clinical trial of its IB003 cancer treatment with only two patients left to enrol.
Once the study is complete, the company will move into phase II, where the drug, a gallium maltolate therapy for children's brain cancer, will be tested on a larger group of participants.
This will help determine researchers assess its effectiveness, building on the early data that has already shown the treatment to be safe and exhibiting positive signs of success.
In a letter to shareholders, Michael Schmainda, CEO of the company's Imaging Biometrics arm, provided updates on these developments, noting that preparations are already underway for a crucial meeting with the US Food and Drug Administration (FDA) that will help advance the treatment’s development.
Progress in the company’s Expanded Access Program (EAP), which allows non-trial patients to access the treatment, has been slower than anticipated, largely due to delays in the hospital approval processes; however, three sites in New York, North Carolina, and California are now active, and two patients have already started receiving the treatment.
IQ-AI retains full rights to the phase I trial data and remains fully committed to advancing the drug through future phases of development, with early results showing no toxic side effects and initial signs of positive outcomes, the letter said.
Schmainda also highlighted the significance of IQ-AI's Rare Pediatric Disease Designation (RPDD) from the FDA, which could provide a valuable voucher to accelerate the drug’s regulatory approval, though legislative efforts are currently underway to extend the program beyond its scheduled 2026 expiration date.
In addition to the ongoing drug trials, the company recently released a promotional video for its IB Nimble device, which showcases its potential to help manage complex diseases by offering healthcare professionals a new, mobile solution for timely and secure disease management.
IQ-AI is also focused on its AI-driven technology, IB Zero G, which aims to improve medical imaging for vulnerable patient groups, including children and pregnant women, though regulatory clearance for this product is still in progress.
With phase I trial results and real-world data from the EAP expected in early 2025, IQ-AI believes these insights will significantly inform its commercialisation strategy for the future.
In the meantime, the company is exploring a variety of funding options to support its growth plans.