This designation is an important achievement in the regulatory path for RECCE 327 with the FDA and has significant benefits to the business.
Recce’s application to the FDA is for RECCE 327 as a broad spectrum antibiotic, used intravenously against Escherichia coli and Staphylococcus aureus bacteria in the blood, including the superbug strains.
These infections often lead to sepsis or ‘blood poisoning’ and are life threatening if untreated or if treatment is not effective.
Through the grant of QIDP designation, RECCE 327 is labelled for fast track designation, which is designed to speed the FDA’s review process and allows QIDP designated drugs that treat serious or life-threatening conditions and fill an unmet medical need, to be expedited for review in order to facilitate their development.
In addition, if RECCE 327 completes the necessary clinical trials and is approved by the FDA, the QIDP designation will provide five years of market exclusivity, starting from the date of the new drug application approval, extended for another five years through Hatch-Waxman exclusivity. Additional protection is provided by the company’s patents.
QIDP designation is part of the US Generating Antibiotic Incentives Now (GAIN) Act and was formed with the view to encourage development of new treatments for antibiotic-resistant organisms known to cause serious or life-threatening infections.
Dr Graham Melrose, Executive Chairman at Recce, said: “The fact that RECCE 327 meets the FDA’s criteria for Qualified Infectious Disease Product designation is a tremendous validation of our strategy to invest in synthetic polymers as potentially a whole new-class of antibiotics.”
“This designation is an important step of the regulatory process, with RECCE 327 clearly in the FDA’s sight, and is well positioned to continue communications with them.”
Announcing the positive news during World Antibiotic Resistance Awareness Week, when the urgent need for new antibiotics to address the rapidly emerging threat of superbugs, Dr Graham Melrose added: “Our plans for RECCE 327 are on track to progress its development towards clinical testing in humans; we are encouraged that it has the potential to play an important role in the global challenge of antibiotic resistance.”
