The Clinical Pathway to Antibiotic Approval*
There are three distinct phases of clinical evaluation prior to approval for new drugs.
*For illustrative purposes only - based upon available information.
There is an urgent global need for new antibiotics with capability to treat life-threatening diseases. Our lead drug candidate (RECCE® 327), not yet approved for human use, was awarded Qualified Infectious Disease Product (QIDP) designation in late-2017, a legal status, as part of the US Generating Antibiotic Incentives Now (GAIN) Act, labelling it for Fast Track Designation, plus 10 years of market exclusivity post approval.
There are multiple legislative and regulatory initiatives available to a new antibiotic developer such as Recce, which are intended to facilitate and expedite drug development and review, with potential time/cost opportunities available along the way.
These studies are usually conducted in 20-80 healthy volunteers. The aim is to determine if the drug is safe, if it has any side effects and how the drug is metabolized and excreted.
These studies begin if Phase I studies don't show any unacceptable toxicity or side effects and are usually conducted in 20-80 unwell patients. The focus in Phase II 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 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. 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.