Scientia Clinical Research Subjects Dosed in RECCE® 327 Rapid Infusion Phase I/II UTI Clinical Trial

Highlights:

 

-          Dosing at Scientia Clinical Research has commenced with first male and female subjects dosed – ahead of schedule, site expansion recently announced

-          Subjects who received RECCE® 327 (R327) were dosed at faster infusion rates than that of subjects in recently completed Phase I Clinical trial

-          Remaining Cohort subjects to be dosed this week

 

SYDNEY Australia, 24 July 2023: Recce Pharmaceuticals Ltd (ASX:RCE, FSE:R9Q) (the Company), the Company developing a new class of Synthetic Anti-infectives, is pleased to announce Scientia Clinical Research has successfully begun dosing both male and female subjects in its Phase I/II UTI clinical trial evaluating RECCE® 327 (R327) at faster infusion rates.

 

As announced 10th July 2023, the Company had expanded its clinical trial sites to include Scientia Clinical Research, located in Sydney, New South Wales, to assist in accelerating patient recruitment and broadening patient population. Scientia has advanced dosing ahead of schedule, with subjects receiving R327 at two faster infusions rates of 2,500mg via I.V. administration.

 

The study is tracking to primary end-points, with the remaining subjects to be dosed this week at Scientia Clinical Research, with expected data read-outs in H2 2023.

 

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

 

This announcement has been approved for release by Recce Pharmaceuticals Board.

 

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.