Recce Pharmaceuticals Announces Safety Committee Approves Faster Infusion Rate in Phase I/II Trial of RECCE® 327 for Urinary Tract Infections and Urosepsis
Independent Safety Committee approves the next cohort dosing of RECCE® 327 (R327) at a faster infusion rate of 15 minutes of 3,000mg via intravenous (IV) administration
R327 was shown to be safe and well-tolerated in healthy subjects at previous infusion rates of 1 hour and 30 minutes of 3,000mg
Subject recruitment in the next cohort is well underway, with dosing to begin imminently
SYDNEY, Australia, Oct. 25, 2023 (GLOBE NEWSWIRE) -- Recce Pharmaceuticals Ltd (ASX: RCE, FSE: R9Q) (the Company), the Company developing a new class of synthetic anti-infectives, today announced an Independent Safety Committee has approved the next cohort dosing at a faster infusion rate of 15 minutes of 3,000mg in a Phase I/II clinical trial evaluating its lead anti-infective candidate, RECCE® 327 (R327), which was shown to be safe and well-tolerated in healthy subjects at 1 hour and 30-minute infusion rates of 3,000mg. The next cohort of subjects has been recruited, with dosing to begin imminently.
“We are pleased to receive approval from the Independent Safety Committee to commence dosing of R327 at 15 minutes, a faster infusion rate than what has been administered in previous doses at 1-hour and 30-minute infusion rates,” said James Graham, Chief Executive Officer of Recce Pharmaceuticals. “This data reaffirms R327’s potential as a first-line treatment for patients with UTIs and life-threatening infections such as urosepsis or sepsis, as the mortality of sepsis increases by 6-8% for every hour that treatment is delayed.”
Receiving the committee’s approval to proceed with dosing R327 at a 15-minute infusion rate of 3,000mg is a positive indication of R327’s advancement as a broad-spectrum anti-infective across the full spectrum of urinary tract infections (UTIs), including simple, complicated, and recurring, for its all-out septic state, ‘urosepsis.’ If left untreated, UTIs are responsible for about 30% of all sepsis infections, defined as ‘urosepsis.’1 This clinical trial aims to showcase R327’s potential as a first patient presentation ‘fast-in-fusion’ therapy designed to stop any bacterial infection in its tracks.
Antibiotics administered as an IV infusion, usually over 30 minutes, have benefits such as savings in nursing time, reduced costs, and improved safety. In an outpatient setting, IV rapid infusion of antibiotics is useful, as the speed of medication infusion can impact the number of patients treated, patient wait times, and the duration that patients are connected to infusers.2 The 2021 Surviving Sepsis Campaign (SCC) guidelines strongly recommend administering IV broad-spectrum antibiotics as soon as possible, preferably within an hour of sepsis recognition.3
The Phase I/II trial is evaluating the safety, pharmacokinetics, and pharmacodynamics of R327 following various intravenous doses and infusion rates in healthy subjects. More information on this trial can be found at the Australia New Zealand Clinical Trial Registry (ANZCTR) 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
1 https://bmcinfectdis.biomedcentral.com/articles/10.1186/s12879-022-07538-5
2 https://www.ijidonline.com/article/S1201-9712(21)00574-9/fulltext
3 https://pubmed.ncbi.nlm.nih.gov/34605781/
