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Treatment for infectious diseases continues to pose a significant threat to populations worldwide, with the effectiveness of many anti-infective medications lost to antimicrobial resistance (AMR).

However, in this current era where concerns regarding antibiotic-resistant infectious diseases are prevalent, Recce Pharmaceuticals (RCE) is levelling the playing field with a groundbreaking new class of synthetic anti-infectives.

Recce’s pipeline includes the world’s most clinically advanced new class of anti-infectives focussed upon the urgent global health threat of antibiotic-resistant superbugs. With RECCE®327 (R327) as an intravenous therapy featured in The Pew Charitable Trusts Global New Antibiotics in Development Pipeline, as the world’s most advanced new class of polymeric antibiotics and the only clinical-stage sepsis drug candidate.

The company believes these anti-infectives can be used as broad-spectrum therapeutic potential for major unmet medical needs including sepsis/urosepsis, urinary tract infections (UTI), diabetic foot infections (DFI), and burn wound infections.

According to Recce, its novel technology is the first new class of antibiotic the world has seen in more than three decades and is well along the journey to commercialisation.

Of most importance is the company’s lead drug candidate R327, which has recently completed phase one testing in humans. The drug is being investigated for a range of indications including both complicated and uncomplicated UTIs, urosepsis, as well as topical application on burn wounds and DFIs.

The company has been independently valued by research body Edison Research at $535.6 million and an equity price of $3.00 a share, which is a soaring increase to the company’s current market cap.

The company plans to hone in on the capital it needs through future partnerships, funding and investment support to unlock the research and development potential of its ground-breaking, and world-changing anti-infectives.

Current research and development milestones

This year, RCE inked further approvals from the Australian Patent Office (APO) in April for the first of its new ‘Patent Family 4’.

The approvals relate to the company’s use of R327 and R529 to treat bacterial and viral infections, specifically validating Recce’s anti-infectives from previous studies in burn wounds, UTIs, gonorrhoea, influenza, and COVID-19.

In an interview with The Market Herald, RCE Executive Chair Dr John Prendergast said this year was all about discovering R327’s potential to become a successful treatment for hard-to-cure UTIs.

“With HREC approval we are now able to conduct a number of clinical trials that will demonstrate for the first time clearly the therapeutic potential, and the efficacy of this drug in a patient population [presenting with] UTIs,” he said.

In July, RCE began its phase I/II intravenous clinical trials for R327 in humans, which assessed the effectiveness and safety of R327 at South Australia’s CMAX clinical research facility and has subsequently expanded the trial to New South Wales Scientia Clinical Research.

With the first cohort already dosed, the phase I/II trial will look at assessing R327 as an intravenous dose at faster infusion rates across three cohorts of participants. During and following dosing, plasma and urine will be collected to evaluate R327’s antibacterial and concentration effects.

“Peak concentrations of R327 in urine noted in this study have been shown in vitro in human urine to effectively kill E. coli within minutes, not hours, as is seen for currently used and approved antibiotics for UTI treatment,” Dr Prendergast added.

R327 has also been developed as a topical agent for DFIs, which also received HREC approval in December 2022 to begin a phase I/II DFI study.

Although not yet approved for clinical use, R327 was used as a topical gel administration (R327G) under the Therapeutic Goods Administration’s Special Access Scheme, Category A by a qualified medical practitioner on five patients. All patients treated with R327G responded well to treatment with complete eradication of antibiotic-resistant infections.

The global antibiotics market was valued at A$55.86 billion (US$38.08 billion) in 2021 and is projected to grow to $66.46 billion (US$45.30 billion) in 2028 at a CAGR of 2.5 per cent.

In September, Recce announced a capital raising of approximately $11 million before costs, with $8 million commitments received in a strongly supported placement to new and existing institutional and sophisticated investors and an entitlement offer being available to existing shareholders to raise up to approximately $3 million (before costs).

The company is also supported by the Australian Government’s R&D tax rebate, receiving  43.5 per cent for every dollar spent on R&D from the Australian Taxation Office.

Recce also has an at-the-market (ATM) equity financing facility with Acuity Capital that expires in January 2026 and provides up to $20 million of standby equity capital.

Recce’s four wholly-owned patent families include more than 40 issued patents and patent applications across some of the world’s major markets, including the United States, Europe, Japan, China and Australia.

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.

Dr Prendergast said the approval provided a foot in the door for the company to continue with research and development, which has been bolstered by its recent R&D tax refund.

“We have already established several relationships with major pharmas’ who are following us very closely…” he said.

The company has continued to form partnerships to expand its patient population, with its recent clinical trial expansion with Scientia Clinical Research.

RCE CEO James Graham said the company was “pleased” to expand its phase I/II UTI studies with Scientia Clinical Research NSW joining in on dosing at CMAX in South Australia.

“This now multistate study expects to expedite our clinical trial progress and address the global health threats posed by UTIs and Urosepsis,” he said.

In May, Recce was sponsored along with three other WA companies by the State’s Government to attend the 18th BIO Korea International Convention, where Mr Graham met with the world’s leading biotech companies, investors, executives, business experts and researchers.

In June, the company also attended BIO US in Boston Massachusetts, which attracted more than 14,000 biotechnology and pharma industry leaders.

Non-Executive Director and Chief Medical Advisor, Dr Alan Dunton delivered the opening R&D address at the World Antimicrobial Resistance Congress in September, positioning the company as a sign of new hope in the fight against antibiotic-resistant superbugs.

The WHO estimates that some 50 million cases of sepsis occur each year, accounting for 11 million sepsis-related deaths. In approximately 30 per cent of all septic patients, the infectious focus is localised in the urogenital tract (urosepsis).

Recce’s ultimate vision is clear: it wants to pioneer the development and commercialisation of a new class of synthetic anti-infectives to address the urgent global health threat posed by antibiotic-resistant superbugs.

Anti-infectives have revolutionised the field of healthcare, and they play a critical role in curing and even preventing a wide range of life-threatening infections.

Despite a wariness from investors toward pre-profit companies in some industries, the biopharma sector continues to prevail through significant levels of interest and investment.

Ultimately, Recce claims through its multi-layered mechanisms of action, its anti-infectives have the potential to overcome the hypercellular mutation of bacteria – the challenge of all existing antibiotics to date.

Read the full article here: https://themarketherald.com.au/recce-pharmaceuticals-asxrce-paves-its-way-to-commercialisation-with-breakthrough-antibiotic-r327-2023-09-20/

Recce Pharmaceuticals (ASX:RCE) paves its way to commercialisation with breakthrough antibiotic, R327