Recce Pharmaceuticals Completes Dosing Additional Cohort in Phase I/II UTI/Urosepsis Rapid Infusion Trial
12 Jun 2024
Fast TrackQualified Infectious Disease Product
Recce Pharmaceuticals Completes Dosing Additional Cohort in Phase I/II UTI/Urosepsis Rapid Infusion Trial
Six additional participants intravenously dosed with RECCE® 327 (R327) at 4,000mg over 20 minutes – highest dosage to date in this trial
SYDNEY, June 12, 2024 (GLOBE NEWSWIRE) -- Recce Pharmaceuticals Ltd. (ASX:RCE, FSE:R9Q), (the Company), the Company developing a new class of synthetic anti-infectives, today announced it completed dosing an additional cohort in its Phase I/II UTI/Urosepsis trial, evaluating RECCE® 327 (R327) at fast infusion rates.
"We have successfully reached a new milestone in this trial by administering a 4,000mg dose over a fast 20-minute infusion to all subjects, the highest dosage achieved so far in this trial," said James Graham, Chief Executive Officer of Recce Pharmaceuticals. “This is a significant step forward in bringing us closer to establishing R327 as a leading treatment for patients with UTIs or urosepsis."
An Independent Safety Committee will review and evaluate the comprehensive data from the 6-subject cohort, with preliminary results expected in the near weeks.
Data from this trial is expected to pave the way for a Phase II UTI/Urosepsis efficacy trial, potentially establishing R327 as a frontline treatment. Administering antibiotics through rapid intravenous infusions has proven to be a safe and effective method that significantly impacts patient treatment, reduces wait times, and alleviates nursing workloads worldwide.1
The complete data demonstrating the efficacy of R327 via intravenous administration will be made available at the completion of this trial in line with the study protocol. More information on this trial can be found at the Australia New Zealand Clinical Trial Registry under the trial ID ACTRN12623000448640.
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 (R327) 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 (R435) as an orally administered therapy for bacterial infections; and RECCE® 529 (R529) for viral infections. Through their multi-layered mechanisms of action, Recce’s anti-infectives have the potential to overcome the processes utilised by bacteria and viruses to overcome resistance – a current challenge facing existing antibiotics.
The World Health Organization (WHO) added R327, R435, and R529 to its list of antibacterial products in clinical development for priority pathogens, recognising Recce’s efforts to combat antimicrobial resistance. The FDA granted R327 Qualified Infectious Disease Product designation under the Generating Antibiotic Initiatives Now (GAIN) Act, providing Fast Track Designation and 10 years of market exclusivity post approval. R327 is also included on The Pew Charitable Trusts’ Global New Antibiotics in Development Pipeline as the sole synthetic polymer and sepsis drug candidate in development.
Corporate Contact
James Graham
+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)
Michael Fitzhugh
mfitzhugh@lifescicomms.com
Investor Relations (USA & EU)
Guillame van Renterghem
LifeSci Advisors
gvanrenterghem@lifesciadvisors.com
1 https://www.ijidonline.com/article/S1201-9712(21)00574-9/fulltext
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