Recce Pharmaceuticals encouraged by ongoing Phase I/II clinical trial for burn wound infection treatment, shares up - Proactive Investors USA

Recce Pharmaceuticals Ltd (ASX:RCE, OTC:RECEF) has received promising data from its ongoing Phase I/II clinical trial for the treatment of burn wound infections with RECCE® 327 (R327), its proprietary synthetic anti-infective.

The West Australian Health Department sponsored clinical trial at Fiona Stanley Hospital is assessing the safety and efficacy of R327 in patients with infected burn wounds under Trial ID ACTRN12621000412831.

This trial has so far demonstrated a broad-spectrum antibiotic activity from R327 on bacterial burn wound infections, with a visible infection reduction within 24 hours in all patients to date.

While the trial is not yet complete, all acute infections treated with R327 were cleared within five days, with chronic infections clearing up within just seven days. Consequently, clinicians were able to reduce the treatment window from the originally planned 14 days, effectively halving the treatment period.

This initial success has prompted a positive response from investors with shares as much as 12.2% higher to A$0.965 while RCE's market cap before opening was approximately A$149.5 million.

"Highly encouraged by initial success"

Study investigator Dr Ed Raby said: "We are highly encouraged by the initial success of R327 in this topical Phase I/II trial.

"Patients with burn wounds often suffer severe bacterial infections that are painful, prevent wound healing and can even result in death if not properly treated.

"Because many of these bacteria are resistant to most available drugs, we are pleased by the potential in R327 offering a treatment option for patients in need."

Swabs from participant burn wounds prior to treatment returned a wide range of pathogenic bacteria, including Gram-positive (Staphylococcus aureus and Staphylococcus lugdunensis) and Gram-negative (Pseudomonas aeruginosa, Klebsiella pneumoniae, Morganella morganii, Proteus vulgaris, Proteus mirabilis) bacteria, some of which are defined as multi-drug resistant and categorised as difficult to treat due to biofilms.

"Fast and efficient killing activity"

Recce Pharmaceuticals CEO James Graham added: "We are pleased with the progress of our lead compound, R327 in patients harbouring serious burn wound infections.

"This initial update builds upon strong pre-clinical data demonstrating fast and efficient killing activity against common and problematic bacterial strains, and we are excited for the potential of R327 in the clinic.

"We look forward to updating shareholders of further human clinical data points as this trial progresses."

As is common in therapeutic activity on sensitive wound surfaces, patients noted a minor, brief stinging sensation as the solution reached the area of infection, which appeared to subside in line with reduction in bacterial loads.

No adverse effects or abnormalities have been reported among patients.

The study is ongoing, with target patient enrolment/treatment expected early 2022, allowing full data-set reporting to follow.

About Recce Pharmaceuticals

Recce Pharmaceuticals is pioneering the development and commercialisation of new classes 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 is comprised of broad-spectrum synthetic polymer antibiotics RECCE® 327, RECCE® 435, and RECCE® 529 for viral infections with unique mechanisms of action against hyper-mutation on bacteria and viruses, respectively.

Patented lead candidate RECCE® 327 as an intravenous therapy, is being developed for treatment of serious and potentially life-threatening infections including sepsis due to Gram-positive and Gram-negative bacteria including their superbug forms.

Recce's new antibiotic compound, RECCE® 435, has been formulated for oral use.

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 only synthetic polymer and sepsis drug candidate in development.