The Clinical Pathway to Antibiotic Approval
Antibiotic resistance is an urgent global health threat. Multi-drug resistant bacteria, or superbugs, are on the rise and have outpaced the development of effective antibiotics – threatening our ability to treat common infections and support modern medicine.
Globally, over six million people die each year in hospitals due to sepsis, a life-threatening response to an infection for which no specific treatments exist. Doctors treating sepsis patients are in a race against time, with mortality rates increasing by 6% each hour if left untreated.
RECCE® 327 shows potential to reduce drug resistance against traditional antibiotics. Introducing a new treatment option can reduce the use of traditional antibiotics, lowering the selective pressure on bacteria that leads to the development of resistance.
There are three distinct phases of clinical evaluation prior to approval for new drugs.
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.
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.
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.
Sepsis – Clinical Observations…
There are currently no drugs available specific to the treatment of sepsis (blood poisoning). The medical observation of the patients battling the deadly disease is comparatively simple due to its fast acting, highly symptomatic nature. For this reason, compared to other clinical trials, patient outcomes are relatively obvious and accordingly time and associated developmental costs to reach regulatory approval may be less.