Recce Pharmaceuticals Ltd (ASX:RCE, OTC:RECEF) has revealed an updated and ambitious development plan for its anti-infective therapies, aiming to reach commercialisation as quickly as possible.
“The significant progress Recce has made in the last 12 months continues to strengthen and build out the company’s anti-infective platform, paving the way to new and considerable infectious disease programs across a range of unmet medical needs,” Recce Pharmaceuticals CEO James Graham said.
“With good safety and encouraging signs of efficacy, we look ahead to new indications that can best adapt to physician and patient needs.
“We have therefore established an ambitious development plan, aiming to get new anti-infective therapies into market as expediently possible.”
Trial indications and forward plan
Recce has outlined the results of several of its recent clinical trials, revealing expected timelines for the next phase of assessment.
Phase 1 Safety/Tolerability study for R327
RCE’s Phase 1-a, 1-hour single dose intravenous study demonstrated R327 to be safe and well tolerated when administered to 60 healthy male adult volunteers, paving the way for a Phase 1-b/2-a multi-dose and early-stage sepsis efficacy study.
The company expects to dose the first subject later this year, with the trial running for about 12 months.
Phase 2 clinical trial of R327 for treatment of Urinary Tract Infections (UTI)
Clinical data from an ongoing Phase 1 clinical trial has revealed high concentrations of R327 in urine of healthy volunteers.
The company says this insight is consistent with pre-clinical in-vivo kidney and UTI bacterial infection studies and supports primary excretion through the urine, suggesting opportunities for therapeutic activity in the urinary tract.
UTIs are very common, having a prevalence of 11% in the overall population with many infections being recurrent or resistant to antibiotics.
About 25% of sepsis cases also originate from the urogenital tract. Urosepsis is a form of sepsis caused by a broad arrange of bacterial infections of the urinary tract, including cystitis, lower urinary tract and bladder infections and upper urinary tract and kidney infections.
While Recce works to finalise the study protocol, the Phase 2 clinical trial is expected to see first patient dosing in the early part of next year.
Phase II study on Diabetic Foot Ulcer infections at leading NSW teaching hospital
Building on RCE’s ongoing topical burn wound infection program, the company intends to develop topical broad-spectrum bacterial infection treatment programs, through the design of a new Phase 2 clinical study for Diabetic Foot Ulcer infections at a leading Australian teaching hospital.
The trial will assess R327 as a topical broad-spectrum antibiotic therapy for mild skin and soft tissue diabetic foot ulcers (DFU) with first patient dosing expected in the fourth quarter of this calendar year.
Multiple pre-clinical programs progressed to advanced stages
Recce has demonstrated strong in-vitro and in-vivo activity of R327 in multiple pre-clinical programs, including against a variety of deadly pathogens such as Streptococcus pneumoniae, Helicobacter pylori, and Mycobacterium abscessus – a dangerous pathogen among cystic fibrosis patients.
The company expects to present independent studies across RCE’s portfolio of pre-clinical programs in the near term.