Recce Pharmaceuticals is addressing the historic lack of innovation in anti-infective drug development and the growing need for effective treatments against resistant bacteria
Pipeline
Across Multiple Indications and Upcoming Inflection Points
Program andRoute of
Administration | Indications | Discovery | Preclinical | Phase I | Phase II | Phase III | Market |
|---|---|---|---|---|---|---|---|
| R327 Topical Gel Registrational Trials | Diabetic Foot Infections Phase 3 Indonesia (ASEAN) | ||||||
| Diabetic Foot Infections Phase 3 Australia (for US FDA submission) | |||||||
| R327 Intravenous and Backups | cUTI/Hospital and Ventilator Acquired Pneumonia Other Serious Infections | ||||||
| Aerosol for Inhalation | Hospital Acquired Pneumonia Ventilator-Associated Pneumonia Serious Lung Infections | ||||||
| Civil and Dept of Defense Programs | Burn Wound Infections | ||||||
A Dual Phase 3
Global Strategy
Two registrational clinical trials of R327G, each supporting a distinct regulatory pathway.
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Phase 3 Australia
Designed to TGA and US FDA regulatory standards to support registration in Australia and the United
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Design
Randomised, active-controlled, non-inferiority study component comparing R327G with one of four physician-selected comparator antibiotics
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Enrolment
Enrolment 208 participants in the active-controlled study component, with an interim analysis after 104
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Patients
Mild and moderate diabetic foot infections
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Phase 3 Indonesia
Approved by Indonesia's Badan POM, with data positioned as a gateway to ASEAN markets
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Design
Double-blind, placebo-controlled
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Enrolment
Up to 310 participants, with an interim analysis after 155
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Primary endpoint
Clinical response on the Lipsky Scale
A Clinical Pathway to
Antibiotic Approval
Phase I
Safety and Dosage
Phase I trials usually involve 20 to 80 healthy volunteers to assess the safety of a new drug. Key objectives include evaluating safety, identifying potential side effects, and understanding how the drug is metabolised and excreted.
Phase II
Efficacy and Side Effects
Phase II trials typically involve up to several hundred patients with the target condition. The focus is on evaluating the drug’s efficacy while continuing to monitor safety and short-term side effects. At the conclusion of this phase, the drug developer will consult with the TGA (Therapeutic Goods Administration) and the FDA to discuss the next steps.
Phase III
Confirmatory Trials
Phase III studies recruit hundreds to thousands of patients. The goal is to gather extensive data on the drug’s safety and efficacy across diverse populations, including use alongside other treatments and potential drug interactions.