Recce Pharmaceuticals Ltd (ASX:RCE, OTC:RECEF) has made strong progress in the last six months or so, advancing several of its treatments through clinical milestones as well as gaining support from the US Department of Defence.
Notably, the company’s UTI/Urosepsis Phase I/II trial demonstrated promising minimum inhibitory concentration (MIC) activity, with the trial expected to move to the next dosage increase within the next few weeks.
The Phase I/II Diabetic Foot Infection (DFI) clinical trial has also expanded after demonstrating efficacy of the treatment and will now move to a Phase III registrational trial in Indonesia, set to begin in the third quarter of this year.
R327 tested against 300 pathogen strains
In addition to its clinical achievements, Recce also engaged Linnaeus Bioscience to test RECCE® 327 (R327) against more than 300 strains between the ESKAPEE group of pathogens (198 Gramnegative and 111 Gram-positive bacteria strains).
“R327 is effective against all strains tested at MICs,” Linnaeus chief operations officer Hannah Tsunemoto PhD said, having led the experiments.
More than 95% of the strains tested were clinically isolated from a variety of sources, including but not limited to wounds, blood, urine and sputum (phlegm).
Furthermore, in a 31-day sub-MIC serial exposure study, R327 was tested against a Multi-Drug Resistant (MDR) strain of Escherichia coli (E. coli) and showed no evidence of induced resistance to R327.
Government support
In a major endorsement of the company’s treatment platform, the US Department of Defence recommended RECCE® 327 Gel (R327G) as a topical treatment for Burn Wound Infections for grant funding to the tune of US$2.2 million, about A$3.34 million.
The company also plans to submit an investigational new drug (IND) application to the US Federal Drug Administration (FDA) in the second half of 2024, based on results from its ongoing Phase I/II UTI/Urosepsis rapid infusion clinical trial.
The company says the success of its Phase I safety and tolerability trial coupled with the promising interim data from its Phase I/II UTI/Urosepsis clinical trial on both safety and efficacy and the treatments capability to be administered over multiple fast infusion times position R327 well for its upcoming IND application.
RCE has also recently garnered international recognition for its synthetic anti-infective, having presented at Biomedical Advanced Research and Development Authority (BARDA), Opening Keynote Address and Opening R&D Address at the World AMR Congress 2024 and sponsorships received from both the Western Australian and New South Wales governments for the BIO International Convention 2024.