Tetratherix has exported its first commercial shipment of Tetramatrix polymer to the United States, marking the start of product revenue for the ASX-listed company’s Precision Medicine franchise.
The shipment, sent under Tetratherix’s exclusive licence and supply agreement with US partner Superpower Health, is intended to support development of intranasal delivery products for the American consumer health and longevity market. It represents a shift from a licensing arrangement to an operational supply relationship, with the material to be used during a trial period designed to finalise supply processes and begin collecting data.
The company said product revenue from the shipment will be additional to its existing US$3 million annual exclusive licence fee.
Tetratherix chief executive Will Knox described the dispatch as an important commercial proof point for the company’s proprietary polymer platform.
“This first commercial dispatch of our proprietary polymer is a significant proof point for Tetratherix,” he said. “It demonstrates that we can take Tetramatrix from validated science through to commercial-grade product in the hands of a US partner.”
The export follows the successful scale-up of Tetratherix’s manufacturing and quality systems from pilot production to commercial-grade production at its existing facility. The company said the work established a pathway for materially greater polymer production when its planned advanced manufacturing campus is commissioned.
A key step in the export process was the US Food and Drug Administration’s assignment in June of a Unique Ingredient Identifier number to the Tetramatrix platform polymer, which is branded for the program as STEPP. Tetratherix said the identifier formalised registration of its proprietary polymer substance and enabled an export pathway to the US market.
The commercial milestone has been accompanied by a scientific development. A paper outlining the technology underpinning the STEPP program has been accepted for publication in the International Journal of Pharmaceutics.
The manuscript examines intranasal delivery of semaglutide using Tetratherix’s thermoresponsive PNPHO nanocarrier. Semaglutide is a GLP-1 receptor agonist widely used to treat type 2 diabetes and support weight management.
The study, conducted with researchers from Macquarie University, the Woolcock Institute of Medical Research, and Aptar Pharma, found that the polymer could be formulated as a nanocarrier that improved semaglutide transport across nasal epithelial tissue and prolonged nasal retention in preclinical models.
