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ASX: RCE

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ASX: RCE

$0.0

ASX: RCE

$0.0

Pipeline

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)
Acute Bacterial Skin and Skin Structure Infections (DFI) 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
  • Approval received from the Indonesian Drug and Food Regulation Authority, Badan POM, to initiate its Registrational Phase 3 clinical trial in Indonesia
  • ABSSSI includes postoperative infection, wound infections and diabetic foot infections
  • Completed pilot civil Phase II Burn Wound Infections Study; US$2M grant for Department of Defense pre-clinical pipeline in progress
  • Cooperative Research and Development Agreement signed with US Army Medical Research Institute of Infectious Diseases, to test R327 against biothreat pathogens in established in vitro models.

A Clinical Pathway to

Antibiotic Approval

There are three distinct phases of clinical evaluation prior to approval for new drugs:

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.