Recce Pharmaceuticals Announces First Cohort Dosed in RECCE® 327 Rapid Infusion Phase I/II Urinary Tract Infection (UTI) Clinical Trial

Highlights:

• First cohort in Phase I/II urinary tract infection (UTI) rapid infusion intravenous (IV) study successfully dosed 2,500mg of RECCE^® 327 (R327), resulting in high peak urine concentrations, as previously demonstrated in a completed Phase I clinical trial
• High concentrations of R327 in urine are expected to demonstrate a rapid kill rate of bacteria in line with pre-clinical UTI study results
• First female safely dosed with R327 IV 2,500mg at 30-minute infusion
• Broadened patient population by accelerating recruitment in Adelaide (CMAX) and Sydney (Scientia Clinical Research) to meet study schedule
• Results will define dose(s)/infusion rates for upcoming Phase II single-dose study in patients with UTIs

SYDNEY, Australia, July 11, 2023 (GLOBE NEWSWIRE) — Recce Pharmaceuticals Limited (ASX: RCE, FSE: R9Q), the Company developing a new class of synthetic anti-infectives, is pleased to announce it dosed the first cohort of both male and female subjects with no serious adverse events in a Phase I/II urinary tract infection (UTI) clinical trial evaluating RECCE^® 327 (R327) at faster infusion rates.

“This current study builds off of Recce’s completed 80 subject Phase I study of R327 administered as a 1-hour infusion, demonstrating that R327 concentrated in the urine by at least 15-fold compared to plasma concentrations,” said Alan W Dunton, MD, Non-Executive Director of Recce Pharmaceuticals and Medical Monitor of the Phase I/II clinical trial. “Peak concentrations of R327 in urine noted in the study have corresponded to in vitro results in human urine to effectively kill E. coli within minutes, not hours, as is seen for currently used and approved antibiotics for UTI treatment. It is estimated that more than 70% of UTI patients have bacteria in their urine, which are now resistant to two or more antibiotics.¹ Furthermore, UTI infections are the foundational contributor to more than 30% of sepsis cases globally.²”

Participants in the cohort were all dosed at two faster infusion rates of 2,500mg compared to the Company’s completed 80 subject Phase I study and included the first female to receive R327 via IV administration. Assessments are being conducted to determine the effectiveness of R327’s antibacterial activity in the urine of dosed participants.

Full details on the trial can be found on anzctr.gov.au under the Trial ID ACTRN12623000448640.

The Company believes the results from this current study will showcase the potential of R327 as a positive therapeutic against any bacteria, including Gram-positive and/or Gram-negative bacteria, in addition to ESKAPE pathogens in patients in future studies.

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

¹ Ahmed SS, Shariq A, Alsalloom AA, Babikir IH, Alhomoud BN. Uropathogens and their antimicrobial resistance patterns: Relationship with urinary tract infections. Int J Health Sci (Qassim). 2019
² Qiang XH, Yu TO, Li YN, Zhou LX. Prognosis Risk of Urosepsis in Critical Care Medicine: A Prospective Observational Study. Biomed Res Int. 2016