Recce Pharmaceuticals Doses Subjects in Rapid Infusion Phase I/II UTI Clinical Trial of RECCE® 327 at Scientia Clinical Research
- Dosing at Scientia Clinical Research has commenced with first male and female subjects dosed ahead of schedule
- Subjects who received RECCE® 327 (R327) were dosed at faster infusion rates than subjects in recently completed Phase I clinical trial
- Remaining cohort subjects to be dosed this week
SYDNEY, Australia, July 26, 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 announce it dosed both male and female subjects in a Phase I/II urinary tract infection (UTI) clinical trial evaluating R327 at faster infusion rates at Scientia Clinical Research.
As previously announced, the Company expanded its clinical trial sites to include Scientia Clinical Research, located in Sydney, New South Wales, to assist in accelerating patient recruitment and broadening the patient population. Scientia Clinical Research has advanced dosing ahead of schedule, with subjects receiving R327 at two faster infusion rates of 2,500mg via intravenous (IV) administration.
The study is tracking to meet primary endpoints, with the remaining subjects to be dosed this week at Scientia Clinical Research, with expected data read-outs in 2H 2023.
Full details on the trial can be found on anzctr.gov.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
