Recce Pharmaceuticals Announces Expansion and Acceleration of Clinical Programs

2022-10-03

合格传染病产品快速通道

Highlights:

Phase 1 safety and tolerability study of RECCE® 327 (R327) advancing to a Phase 1b/2a multi-dose and sepsis efficacy study

Initiating two new Phase 2 trials of R327 for the treatment of urinary tract infections (UTIs) and diabetic foot ulcer (DFU) infections, respectively

Multiple preclinical programs progressing to advanced stages

SYDNEY Australia, Oct. 03, 2022 (GLOBE NEWSWIRE) -- Recce Pharmaceuticals Ltd (ASX:RCE, FSE:R9Q) (the Company), the Company developing new classes of synthetic anti-infectives, is pleased to provide an updated timeline on its clinical programs with several significant data read-outs in 2022 and 2023.

“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,” said James Graham, Chief Executive Officer of Recce Pharmaceuticals. “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.”

Phase 1 safety and tolerability study advancing to a Phase 1b/2a multi-dose and sepsis efficacy study

Following the initial success of the ongoing Phase 1a study, which has demonstrated R327 to be safe and well-tolerated when intravenously administered in over 60 healthy male adults, the Company is advancing to a Phase 1b/2a multi-dose and early-stage sepsis efficacy study. The first patient is expected to be dosed later this year, and the Company anticipates the trial will run for approximately 12 months.

Initiating a Phase 2 trial of R327 for the treatment of UTIs

Data from the ongoing Phase 1 study has revealed high concentrations of R327 residing in urine in the bladder of healthy volunteers. This insight is consistent with in vivo pre-clinical studies of kidney and UTI bacterial infections and supports primary excretion through the urine, suggesting opportunities for therapeutic activity in the human urinary tract.

UTIs are the most common outpatient infections in the U.S., affecting 20% of women over the age of 65 and about 11% of the overall population, with many being recurrent/antibiotic-resistant infections. Approximately 25% of sepsis cases originate from the urogenital tract, with urosepsis representing a form of sepsis caused by a broad range of urinary tract bacterial infections, including cystitis, lower urinary tract and bladder infections and upper urinary tract and kidney infections.

While the Company works to finalize the study protocol, the first patient in the Phase 2 trial is expected to be dosed in early 2023.

Initiating a Phase 2 trial for the treatment of DFU infections at a leading Australian teaching hospital

Building on the success of its ongoing topical burn wound infections study, the Company has advanced its topical broad-spectrum bacterial infection treatment programs through the design of a new Phase 2 trial for the treatment of DFU infections at a leading Australian teaching hospital.

The trial will assess R327 as a spray-on (topical) broad-spectrum antibiotic therapy for mild skin and soft tissue DFUs, with the first patient expected to be dosed in Q4 2022.

DFU is a chronic and devastating condition affecting an estimated 13% of people in North America.1 This condition carries a 5.5% mortality rate and 34.1% of patients will require amputations within one year of the first ulcer or sign of gangrene.2

Multiple preclinical programs progressing to advanced stages

The Company’s preclinical programs focused on the treatment of significant unmet medical needs for infectious diseases have demonstrated strong in vitro and in vivo activity of R327 against a variety of deadly pathogens, including Streptococcus pneumoniae (S. pneumonia), Helicobacter pylori (H. pylori), and Mycobacterium abscessus (M. abscessus) – a dangerous pathogen among cystic fibrosis patients. The Company expects to announce findings from independent studies of its portfolio of preclinical programs in the near term.

About Recce Pharmaceuticals Ltd

Recce Pharmaceuticals Ltd (ASX: RCE, FSE: R9Q) 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 unique and 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.

Recce wholly owns its automated manufacturing, ready to support first-in-human clinical trials. Recce’s anti-infective pipeline seeks to exploit the unique capabilities of RECCE® technologies targeting synergistic, unmet medical needs.

Corporate Contact

James Graham

Recce Pharmaceuticals Ltd

+61 (02) 9256 2571

James.graham@recce.com.au

Media and Investor Relations (AU)

Andrew Geddes

CityPR

+61 (02) 9267 4511

ageddes@citypublicrelations.com.au

Media and Investor Relations (USA)

Jordyn Temperato