Highlights: Phase I trial agreement with leading clinical research organization Human safety and tolerability study to assess infusion of RECCE ® 327 in 40 healthy subjects as a single ascending dose Estimated start-to-completion with data read-outs less than 12 months from now First patients expected to be dosed in second half of 2020
Highlights:
- Phase I trial agreement with leading clinical research organization
- Human safety and tolerability study to assess infusion of RECCE® 327 in 40 healthy subjects as a single ascending dose
- Estimated start-to-completion with data read-outs less than 12 months from now
- First patients expected to be dosed in second half of 2020
SYDNEY, Australia, April 08, 2020 (GLOBE NEWSWIRE) -- Recce Pharma Ltd (ASX: RCE), the company developing a new class of broad-spectrum synthetic antibiotics, today announced it has formalized a Phase I clinical trial agreement to conduct a first-in-human study of its lead compound RECCE® 327 in 40 healthy subjects.
The Phase I clinical study of RECCE® 327 will be conducted at a specialized clinical trial facility in Sydney, Australia, independent of the hospital system. This initiative seeks to ensure continuity of the independent study and not add to infectious disease pressures for beds around the country. The first patients in this study are expected to be dosed in the second half of 2020.
The randomized, double blind, placebo-controlled single-ascending dose study will involve up to 40 healthy subjects to evaluate safety, tolerability, pharmacokinetic and pharmacodynamic properties of RECCE® 327; and is expected to take less than 12 months from now, with regular interim data updates.
Recce Chairman Dr. John Prendergast said, “The formalization of the clinical trial agreement is a major milestone towards advancing RECCE® 327 through the clinic. It brings us a step closer to addressing the rising rates of antibiotic resistance with a synthetic antibiotic that has shown extraordinary preclinical potential to fight off a broad range of bacterial infections, including superbug forms, even with repeated use.”
RECCE® 327 is a broad-spectrum synthetic antibiotic formulated using synthetic polymer technology to treat blood infections and sepsis derived from Escherichia coli and Staphylococcus aureus bacteria. It is one of the first new classes of antibiotic in over three decades effective against both Gram-negative and Gram-positive bacteria with a novel universal mechanism of action.
Sepsis is a potentially life-threatening condition most caused by bacterial infection in the blood and results in the immune system mounting a hyperactive inflammatory response to the bacteria/ toxins, which can quickly lead to tissue and organ injury, and ultimately death. There are currently no drug therapies available specifically targeted for the treatment of sepsis, and therefore there is a desperate and unmet medical need for new, safe and efficacious treatments. According to the World Health Organization, sepsis is estimated to affect more than 30 million people worldwide every year, potentially leading to six million deaths.
About Recce Pharmaceuticals Ltd
Recce Pharmaceuticals Ltd (ASX: RCE) is pioneering the development and commercialization of a New Class of Synthetic Antibiotics with Broad Spectrum activity designed to address the urgent global health problem of antibiotic resistant superbugs.
Recce antibiotics are unique – their potency does not diminish even with repeated use, which is a common failure associated with existing antibiotic use and the resulting emergence of resistant superbugs.
Patented lead candidate RECCE® 327, wholly owned and manufactured in Australia, has been developed for the treatment of blood infections and sepsis derived from E. coli and S. aureus bacteria – including their superbug forms.
The FDA has awarded RECCE® 327 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.
Recce wholly owns its automated manufacturing, ready to support first-in-human clinical trials. Recce’s anti-infective pipeline seeks to exploit the unique capabilities of RECCE® technologies targeting synergistic, unmet medical needs.
For more information, visit recce.com.au and connect with the Company on Twitter, LinkedIn and YouTube.
| Executive Director James Graham | Media & Investor Relations (AU) Andrew Geddes | Media & Investor Relations (USA) Meredith Sosulski, PhD |
