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A global biotech leader in synthetic anti-infectives dual lists in Germany

Updated: Aug 21, 2021

Recce Pharmaceuticals Ltd (ASX: RCE) and (FSE: R9Q) is pioneering a new class of synthetic anti-infectives to address the urgent global health threat posed by superbugs and emerging viral pathogens.

Recce’s anti-infectives have been designed with a unique mechanism of action, with the goal of re-empowering physicians with an effective treatment that may be used repeatedly against a broad range of bacteria and viruses.

· RECCE® 327 is a fast acting, broad-spectrum antibiotic effective against Gram-positive and Gram-negative bacteria, including antibiotic resistant superbugs.

· RECCE® 435 is a broad-spectrum synthetic polymer antibiotic formulated for oral use.

· RECCE® 529 is a synthetic polymer anti-infective focused on viral indications following Recce’s background antiviral research.

The US Food and Drug Administration (FDA) awarded RECCE® 327 a Qualified Infectious Disease Product (QIDP) designation under the Generating Antibiotic Initiatives Now (GAIN) Act - labelling RECCE® 327 for Fast Track designation, plus 10 years of market exclusivity post approval.

Since 1987, no new class of human antibiotics have come on to the market. Our new class of antibiotic has been synthesised using a unique and economic method of manufacture. Unlike current antibiotics, which rely on a specific ‘lock and key fit’ between the antibiotic and the bacteria causing the disease, our antibiotics have been designed to overcome this shortfall, starting at the process of our patented antibiotic synthesis.

Recce is advancing new classes of synthetic polymer anti-infectives with rapid bactericidal and anti-viral activity.

Any bacteria present in the bloodstream is bad bacteria, which can often lead to sepsis. Doctors treating sepsis patients are in a race against time – each hour sepsis goes untreated the likelihood of patient mortality increases by 6%. RECCE® 327 is an efficacious broad-spectrum antibiotic delivered through intravenous (IV) infusion, to treat bacterial sepsis, including strains caused by multidrug resistant bacteria. Once RECCE® 327 enters the bloodstream, it is attracted to the plasma membranes of bacteria via hydrophobic interaction. It binds to the plasma membrane proteins, subsequently weakening the bacterial cell walls.

Due to the unique high metabolic pressure in bacteria, the cell walls collapse or burst (cell lysis), leading to bacterial cell death. Importantly, non-bacterial (eukaryotic) cells remain intact as they do not contain high internal pressures that result in cell lysis.

Applying a Synthetic Approach to Antibiotic Resistant Superbugs

Recce's lead candidate, RECCE® 327, is bactericidal, which means it kills the bacteria rather than inhibiting their growth. Even after repeated use, Recce’s anti-infective compounds show no reduction in efficacy. Preclinical dose ranging studies demonstrated RECCE® 327’s drug concentration in the blood has a large therapeutic window. It remains active long enough to effectively kill pathogenic bacteria, without persisting long enough to induce toxic effects.

Traditional antibiotics generally operate much like a ‘lock and key’ mechanism of action. When a traditional antibiotic is used against a bacterium, it often works until the bacteria mutates and the ‘key’ no longer functions. The new class of compounds synthesized by Recce are polymeric molecules designed to overcome these limitations. Rather than inhibiting a specific bacterial protein or process, RECCE® 327 can overcome potential bacterial mutations through its universal mechanism of action – operating like a ‘master key’.

By introducing RECCE® 327 as a new treatment option to reduce the use of traditional antibiotics, there is potential to lower the selective pressure on bacteria and viruses that lead to the development of resistance.

Strong value drivers

Recce Pharmaceuticals has strong value drivers which should see considerable EU and global investor interest, including:

  • A patent portfolio including more than 20 issued patents and patent applications in the world’s major markets including the United States, Europe, Japan, China and Australia.

  • Recce owns proprietary technology for a new class of synthetic anti-infectives.

  • R327 is addressing the most expensive condition faced by hospitals worldwide – Sepsis. This life-threatening inflammatory response to infection kills more people in the United States each year than prostate cancer, breast cancer and HIV/AIDS combined.

  • Experienced commercial management and board.

  • Wholly owned and automated manufacturing facility in Australia capable of global export.

  • Strong cash position of over €12 million

If any further evidence was needed of the significant interest in anti-infectives look no further than the ex-head of the FDA in America (Scott Gottlieb) and well known expert in biotech investing: “I’m very interested in finding opportunities in the anti-infective space, particularly around multi-drug resistant organisms,” Gottlieb said in an interview. “Anti-infectives have been unloved for a very long time. There’s a huge clinical need.”

Presentations and investor decks

The January 2021 company presentation can be downloaded here

RCE Corporate Presentation Jan
Download PDF • 3.29MB

The January 2021 White Paper

Recce Pharmaceuticals White Paper 2020
Download P • 1.03MB

Here is a link to an excellent video explaining the company's technology

A Recent ASX release noted that R327 is the only synthetic polymer drug candidate in development for treating Sepsis

R327 and Sepsis - ASX Release 15 03 21
Download P • 367KB

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