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- Injectable iron study receives FDA green light
- Next stage of trial set to proceed
- Project targeting addressable market estimated at US$7.41 billion
AFT Pharmaceuticals (ASX:AFP) has obtained positive US Food and Drug Administration (FDA) feedback to proceed with the next stage of its injectable iron research and development project studies.
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The approval allows the company to move to the next stage with its development partner Hyloris Pharmaceuticals to undertake a large global confirmatory study involving 1,366 patients.
The study will be undertaken across multiple geographies planned for New Zealand, China, India, Japan, Armenia, Europe and US.
The novel iron IV development project is targeting a US$7.41 billion addressable market as it advances its development pathway.
MD, Dr Hartley Atkinson, said the results from the phase III clinical trial of the intravenous iron development project is a key to the company’s broad-based growth in its Australian and international businesses supporting a drive towards a NZ$300 million target.
“We have made significant progress laying the foundations for future growth through our licensing operations and research and development program.”
The recent phase III clinical study has generated initial data to support the medicine’s patient benefits of a reduced dosing administrations profile and has also shown fewer side effects and indications of lower toxicity.
Dr Atkinson said that while current intravenous iron therapies are effective, they often present tolerability issues, risk of side effects and typically require multiple infusions, creating a significant treatment burden.
“Our new medicine offers the potential to overcome some of these challenges,” he said.
“In a randomised trial of 146 patients our IV product and administration were compared to an oral iron therapy and the leading iron IV therapy. The study showed that our IV product was well tolerated with an improved dosing schedule.
“Against the leading iron IV therapy, it showed significantly lower delivery complications (2.7% vs. 29.7%); on average precipitated no decrease in blood serum phosphate concentrations, a key safety result as hypophosphatemia is a safety concern for iron injections; and displayed lower concentrations of free iron in patient urine and blood serum, suggesting lower toxicity.”
Following the study the company filed an additional two patent applications covering the use of the iron product.
The upcoming study is expected to take until early 2028 to complete and provided the results are consistent with the just completed study would deliver the data to support the company’s filing for regulatory approval of the treatment across the globe.
AFP is steady at $3.01. Mkt cap $315.6M.
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