Recce Confirms Pre-IND Data Submission To U.S. FDA For Its Lead Antibiotic Candidate
SYDNEY Australia 7 Sept 2017: Recce Limited (ASX: RCE), a pre-clinical stage pharmaceutical company engaged in the development of a new class of synthetic antibiotics, today confirmed it has submitted pre-clinical data and related documentation to the US Food & Drug Administration (FDA) as part of the process for its application to enter human clinical trials for its lead candidate antibiotic, RECCE® 327.
The standard response time for pre-IND submissions is 60 days, including initial feedback and next steps as part of Recce’s Investigational New Drug (IND) program. It is expected there will be at least one more submission of data to support the final IND application for approval to begin human trials.
Recce is developing a new class of broad spectrum synthetic antibiotics to address the global health challenge of antibiotic resistant superbugs. Its current lead candidate RECCE® 327 has been developed for the treatment of sepsis derived from S. aureus and E. coli bacteria – including their superbug forms.
Recce’s submission has been developed with the support of leading US-based multinational life sciences and regulatory consultants.
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Notes To Editors
About Recce Ltd
Recce Ltd (ASX: RCE) is a world-leader in synthetic-polymer compounds, particularly against all bacteria, and viruses. The RECCE® polymers have been synthesized by an extremely economic method. RECCE® polymers have shown in laboratory tests that they have continued activity against bacteria, including superbugs, even after repeated use. Recce has achieved milestones in both pre-clinical trials for FDA purposes, and the development of the manufacture of RECCE® 327. Recce has granted patents in Australia, United States, Europe, Japan and China – giving it legal monopolies, and potential financial returns, from manufacture and distribution of its products in about 80% of the world’s pharmaceutical markets for antibiotics.
The standard response time for pre-IND submissions is 60 days, including initial feedback and next steps as part of Recce’s Investigational New Drug (IND) program. It is expected there will be at least one more submission of data to support the final IND application for approval to begin human trials.
Recce is developing a new class of broad spectrum synthetic antibiotics to address the global health challenge of antibiotic resistant superbugs. Its current lead candidate RECCE® 327 has been developed for the treatment of sepsis derived from S. aureus and E. coli bacteria – including their superbug forms.
Recce’s submission has been developed with the support of leading US-based multinational life sciences and regulatory consultants.
- ENDS -
Notes To Editors
About Recce Ltd
Recce Ltd (ASX: RCE) is a world-leader in synthetic-polymer compounds, particularly against all bacteria, and viruses. The RECCE® polymers have been synthesized by an extremely economic method. RECCE® polymers have shown in laboratory tests that they have continued activity against bacteria, including superbugs, even after repeated use. Recce has achieved milestones in both pre-clinical trials for FDA purposes, and the development of the manufacture of RECCE® 327. Recce has granted patents in Australia, United States, Europe, Japan and China – giving it legal monopolies, and potential financial returns, from manufacture and distribution of its products in about 80% of the world’s pharmaceutical markets for antibiotics.