Recce Pharmaceuticals is addressing the historic lack of innovation in antibiotic drug development and the growing need for effective antibiotics.
Pipeline
Over Various Indications and Upcoming Inflection Points
Asset andRoute of administration | Indications | Discovery | Preclinical | Phase I | Phase II | Phase III | Market |
|---|---|---|---|---|---|---|---|
| R327 Intravenous* | Serious/life threatening bacterial infections including sepsis | ||||||
| Urinary tract infections including urosepsis | |||||||
| Multidose, early stage, rapid infusions sepsis efficacy study | |||||||
| R327 Topical* | Wound infections including infected burns | ||||||
| Diabetic Foot Ulcer Infections | |||||||
| Pre-Clinical Programs* Various routes of administration | Mycobacterium abscessus | ||||||
| Bacterial Sinusitis | |||||||
| Additional TBA |
A Clinical Pathway to
Antibiotic Approval
There are three distinct phases of clinical evaluation prior to approval for new drugs:
Phase I
These studies are usually conducted in 20-80 healthy volunteers and aim to determine if the drug is safe, if it has any side effects and how it is metabolised and excreted.
Phase II
These studies are usually conducted in 20-80 unwell patients. The focus in Phase 2 study is on effectiveness and data on whether the drug works in people who have a certain disease or condition. Safety and short-term side effects continue to be evaluated. At the end of Phase II study the drug developer and the FDA will discuss the structure and size of the final phase.
Phase III
These studies enrol a much larger number of patients than Phase I and Phase II study. The aim is to gather more information about safety and effectiveness of the drug. Phase III studies look at use of the drug in different populations and different dosages and using the drug in combination with other drugs and how it interacts.