Recce Pharmaceuticals, the company developing a new class of synthetic antibiotics, announced it has submitted additional data to the US Food and Drug Administration, including an additional communication request
The additional data pack includes expanded pre-clinical data and a proposed Phase I clinical trial programme for the company’s lead compound RECCE 327, a synthetic antibiotic for the treatment of sepsis derived from Staphylococcus aureus and Escherichia coli — including its superbug forms.
The standard response time for submissions is 21 days.
The submission and request for communication leverages the unique opportunities gained through the fact that RECCE 327 has qualified infectious disease product (QIDP) designation and forms key additions to the company’s overall investigational new drug (IND) application.
The submission was made in conjunction with a leading regulatory and clinical research organisation (which has helped 95% of the world’s 200 top-selling pharmaceuticals).
Executive Chairman Dr Graham Melrose said, “Further communication with the FDA would be an opportunity to further support our new class of antibiotics as we seek to help address urgent human health needs.”