Recce Pharmaceuticals Announces Safety Committee Approves Next Dose of RECCE® 327 at 3,000mg in Phase I/II UTI/Urosepsis Rapid Infusion Clinical Trial

• Independent Safety Committee approves next cohort dosing of RECCE^® 327 (R327) at two faster infusion rates of 3,000mg via IV administration
• Independent Safety Committee unanimously agreed that R327 is safe and well-tolerated in male and female subjects at two faster infusion rates of 2,500mg via IV administration
• Next cohort of subjects recruited, with subject dosing to begin imminently

SYDNEY, Australia, Aug. 29, 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 that an Independent Safety Committee approved the next cohort dosing at two faster infusion rates of 3,000mg in a Phase l/ll urinary tract infection (UTI)/urosepsis clinical trial evaluating its lead anti-infective candidate, RECCE^® 327 (R327). Furthermore, the committee unanimously agreed that R327 at two faster infusion rates of 2,500mg is safe and well-tolerated in male and female subjects. The next cohort of subjects has been recruited, with dosing to begin imminently.

“We are pleased to receive the go-ahead by the Independent Safety Committee to commence dosing of R327 at two faster infusion rates of 3,000mg,” said James Graham, Chief Executive Officer of Recce Pharmaceuticals. “This reaffirms the committee’s view that R327 is safe and well-tolerated at two faster infusion rates of 2,500mg. Results from this trial will pave the way for R327 as a potential first-line treatment for patients suffering from UTIs/urosepsis.”

UTIs are responsible for about 30% of all sepsis infections, defined as ‘urosepsis.’¹ R327’s potential as a treatment option across the patient’s infectious disease journey (underlying infection to septic state) positions it as a therapy in this area of unmet medical need. More information on this trial can be found at the Australia New Zealand Clinical Trial Registry 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

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¹https://bmcinfectdis.biomedcentral.com/articles/10.1186/s12879-022-07538-5