- Cohort dosing at Scientia Clinical Research has been completed ahead of schedule
- Demonstrated RECCE® 327 (R327) to be safe and well-tolerated in male and female subjects at two faster infusion rates of 2,500mg rates via intravenous (IV) administration
- Independent safety committee has reviewed cohort dosing data and is expected to recruit subjects for future cohort
SYDNEY, Australia, Aug. 01, 2023 (GLOBE NEWSWIRE) -- Recce Pharmaceuticals Ltd (ASX: RCE, FSE: R9Q) (the Company), the Company developing a new class of synthetic anti-infectives, is pleased to report the dosing of both male and female subjects in the first cohort of a Phase l/ll urinary tract infection (UTI) clinical trial evaluating R327 at faster infusion rates has been completed at Scientia Clinical Research.
“R327 via two faster infusion rates of 2,500mg across male and female subjects continues to be shown as safe and well-tolerated,” said James Graham, Chief Executive Officer of Recce Pharmaceuticals. “Completing dosing well ahead of schedule is a welcomed confirmation that we are on track to achieve the study’s objectives.”
R327 was shown to be safe and well-tolerated at two faster infusion rates of 2,500mg via IV administration. An independent safety committee has reviewed the complete cohort dosing data and is expected to recommend continuing the study.
Full details on the trial can be found on anzctr.org.au under the Trial ID ACTRN12623000448640.
About Recce Pharmaceuticals Ltd
Recce Pharmaceuticals Ltd (ASX: RCE, FSE: R9Q) is developing a New Class of Synthetic Anti-Infectives designed to address the urgent global health problems of antibiotic-resistant superbugs and emerging viral pathogens.
Recce’s anti-infective pipeline includes three patented, broad-spectrum, synthetic polymer anti-infectives: RECCE® 327 as an intravenous and topical therapy that is being developed for the treatment of serious and potentially life-threatening infections due to Gram-positive and Gram-negative bacteria including their superbug forms; RECCE® 435 as an orally administered therapy for bacterial infections; and RECCE® 529 for viral infections. Through their multi-layered mechanisms of action, Recce’s anti-infectives have the potential to overcome the hypercellular mutation of bacteria and viruses – the challenge of all existing antibiotics to date.
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. Further to this designation, RECCE® 327 has been included on The Pew Charitable Trusts Global New Antibiotics in Development Pipeline as the world’s only synthetic polymer and sepsis drug candidate in development. RECCE® 327 is not yet market approved for use in humans with further clinical testing required to fully evaluate safety and efficacy.
Recce wholly owns its automated manufacturing, which is supporting present clinical trials. Recce’s anti-infective pipeline seeks to exploit the unique capabilities of its technologies targeting synergistic, unmet medical needs.
Corporate Contact
James Graham
Recce Pharmaceuticals Ltd
+61 (02) 9256 2571
James.graham@recce.com.au
Media & Investor Relations (AU)
Andrew Geddes
CityPR
+61 (02) 9267 4511
ageddes@citypublicrelations.com.au
Media (USA)
Jordyn Temperato
LifeSci Communications
jtemperato@lifescicomms.com
Investor Relations (USA & EU)
Guillame van Renterghem
LifeSci Advisors
gvanrenterghem@lifesciadvisors.com
