The US Food and Drug Administration (FDA) will review an antibiotic made by a Sydney medical manufacturer that fights life-threatening blood diseases.
Recce is developing a new class of synthetic antibiotics used intravenously against E.coli and Staph bacteria in the blood, including their superbug forms.
Following an application, Recce’s lead compound, RECCE 327, has been granted Qualified Infectious Disease Product (QIDP) designation.
The antibiotic is eligible for FDA’s fast-track review of designated drugs that treat serious or life-threatening conditions.
Recce has a manufacturing facility in Australia as well as clinical research partners in the US and has validated an automated process to manufacture its lead compound ahead of first-in-man clinical trials.
“The fact that RECCE 327 meets the FDA’s criteria for QIDP designation is a tremendous validation of our strategy polymers as potentially a whole new class of antibiotics,” said Recce’s executive chairman Dr Graham Melrose.
“The designation is an important step of the regulatory process, with RECEE 327 clearly in the FDA’s sight, and is well positioned to continue communications with them.”