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Sepsis - RECCE® 327 I.V.

Overview

Sepsis, or blood poisoning is a life-threatening inflammatory response to infection that has spread to the body. There is no universal treatment for the disease - with the current standard of care being the immediate administration of multiple antibiotics through an intravenous (IV) infusion. Approximately 1/3 patients present unspecific symptoms, leading to delayed treatment and a high mortality rate - 8% increase for every hour left untreated.

Therefore, early treatment with the correct antibiotic is key to the patients’ outcome.

Sepsis Cases and Fatalities by Geographical Area

Worldwide
  • 47-50 million cases
  • 11 million deaths annually
USA
  • 1.7 million cases
  • 270,000 deaths annually
Europe
  • 3.4 million cases
  • 700,000 deaths annually
Australia
  • 55,000 cases
  • 8,700 deaths annually

About RECCE® 327 I.V.

RECCE® 327 (R327) was developed beginning with the end in mind, being entirely synthesised to capture and enhance unique mechanisms of action, able to overcome deadly viral and bacterial infections, including the full suite of ESKAPE pathogens, even in their multi-drug resistant forms.

Any bacteria that enters the blood can be deadly, even more so, when an ESKAPE pathogen enters the blood stream. If left untreated, the body’s reaction to the infection can result in sepsis – a disease for which no specific treatments exist.

Studies indicate Recce’s compounds rapidly and irreversibly shut down bacterial cellular energy ATP production, disrupting important functions within the bacteria, leading to:

  • A reduction in protein synthesis
  • Depolarization of cellular membranes
  • And in higher concentrations - Cell lysis

This multi-layered mechanism of action uniquely allows it to kill bacteria and keep on killing with repeated use, a challenge of all existing antibiotics.

Asset Route of administrationIndicationsDiscoveryPreclinicalPhase IPhase IIPhase IIINext data readoutMarket Size
Anti-bacterial programs
      Phase I interim data readout Q4 2021 47-50 million cases worldwide
      To start post Phase II in sepsis    

The FDA has awarded R327 Qualified Infectious Disease Product designation under the Generating Antibiotic Initiatives Now (GAIN) Act – labelling it for Fast Track Designation, plus 10 years of market exclusivity post approval. Further to this designation, R327 has been included on The Pew Charitable Trusts Global New Antibiotics in Development Pipeline as the only synthetic polymer and sepsis drug candidate in development.

Ongoing Clinical Trials

As one of the most promising developments in the fight against drug resistant bacteria, R327 is undergoing a Phase I clinical trial.

The trial will be held as a randomized, double blind, placebo-controlled single ascending dose study in 80 healthy male subjects. The study seeks to evaluate the safety, tolerability, and pharmacokinetics of R327 following intravenous administration.

For more information on our Phase I clinical trial or to register your interest as a participant visit the CMAX website here

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