Recce Pharmaceuticals is addressing the historic lack of innovation in antibiotic drug development and the growing need for effective antibiotics.
Pipeline
|
Program andRoute of
Administration
|
Indications
|
Discovery
|
Preclinical
|
Phase I
|
Phase II
|
Phase III
|
Market
|
|---|---|---|---|---|---|---|---|
| R327 Topical Gel Registrational Trials | Diabetic Foot Infections Indonesia (ASEAN) | ||||||
| Acute Bacterial Skin and Skin Structure Infections (DFI) - Australia | |||||||
| R327 Topical Gel | Acute Bacterial Skin and Skin Structure Infections | ||||||
| R327 Intravenous | UTI/Urosepsis | ||||||
| Civil and Dept of Defense Programs |
Burn Wound Infections | ||||||
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 20 to 80 patients with a specific 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 and dosages, including its use in combination with other treatments and potential interactions.