- Phase II clinical trial for acute bacterial skin and skin structure infections (ABSSSI) achieves treatment milestone — 20 of 30 patients have now been treated
- All treated patients met the primary endpoints of the study: cure or noticeable improvement after treatment with RECCE® 327 Topical Gel (R327G)
- Completion of treatment for all patients in the calendar year 2024 is realistic
Recce Pharmaceuticals Limited (ASX: RCE, FWB: R9Q) (Recce or that Company), the developer of a new class of synthetic anti-infectives, is pleased to announce that the Company is in its Phase II clinical trial of RECCE® 327 (R327) for topical use as a gel (R327G) in acute bacterial skin and skin structure infections (ABSSSI) is now in its final phase. 20 patients (out of a total of 30 patients) have now been treated and the interim results demonstrate a promising efficacy and safety profile of R327G.
Based on the data, a strong therapeutic response is observed. All patients who completed treatment with R327G achieved a positive outcome in terms of complete cure or noticeable improvement. No serious adverse events (SAEs) have been reported with the use of R237G.
Dr. Alan W Dunton, Chief Medical Advisor of Recce Pharmaceuticals, said: “These interim results represent remarkable progress in our journey to help address critical unmet medical needs for anti-infective therapies. The significant response to R327G makes us very optimistic, especially now that we are nearing completion of the Phase II study. The fact that all patients treated to date have achieved either a complete cure or a noticeable improvement is testament to the potential impact of R327G in the treatment of complex bacterial infections, including diabetic foot syndrome.”
With a view to the imminent completion of the study before the end of 2024, the Company remains committed to its focus on developing a breakthrough topical therapy with synthetic anti-infectives for the treatment of ABSSSI. According to estimates, the ABSSSI market is expected to reach a volume of 26 billion US dollars by 2032. This continuation, following the unanimous recommendation of the Non-DSMB Committee, reflects the positive development of R327G and supports further steps towards an approval process.
Further information about this trial can be found in the Australia New Zealand Clinical Trials Registry under trial identification number ACTRN12624000973516.
This announcement has been approved for publication by the Board of Recce Pharmaceuticals.
About Recce Pharmaceuticals Ltd
Recce Pharmaceuticals Ltd (ASX: RCEFWB: R9Q) is currently developing a new class of synthetic anti-infectives to address the global health challenges associated with antibiotic-resistant superbugs and emerging viral pathogens.
The anti-infectives developed by Recce include three patented, broad-spectrum synthetic polymer anti-infectives: RECCE® 327 (R327) as intravenous and topical therapy, which is used for the treatment of severe and potentially life-threatening infections caused by Gram-positive and Gram-negative bacteria and their ” Superbug” forms are developed; RECCE® 435 (R435) as an orally administered therapy for bacterial infections; and RECCE® 529 (R529) for viral infections. Thanks to their complex mechanisms of action, Recce’s anti-infectives have the potential to successfully overcome the processes used by bacteria and viruses to build resistance – a major challenge for all previous antibiotics.
The World Health Organization (WHO) added R327, R435 and R529 to its list of antibacterial products in clinical development for priority pathogens, recognizing Recce’s efforts to combat antimicrobial resistance. The FDA has designated RECCE® 327 as a Qualified Infectious Disease Product (QIDP) by law (under the Generating Antibiotics Incentive Now (GAIN) Act), which grants an accelerated approval process and 10 years of post-approval market exclusivity. R327 is also the only drug candidate currently in development based on a synthetic polymer for the treatment of sepsis that has been included in the so-called ‘Global New Antibiotics in Development Pipeline’ of the US non-profit organization “The Pew Charitable Trust”.
Recce has full ownership of the automated production that supports current clinical trials. Recce’s anti-infective pipeline aims to leverage the unique capabilities of its technologies to address synergistic unmet medical needs.
https://investorhub.recce.com.au
The source language (usually English) in which the original text is published is the official, authorized and legally valid version. This translation is included for better understanding. The German-language version may be shortened or summarized. No responsibility or liability is assumed for the content, correctness, appropriateness or accuracy of this translation. From the translator’s perspective, the message does not represent a buy or sell recommendation! Please note the original English message www.sedarplus.ca, www.sec.gov, www.asx.com.au/ or on the company website!
https://www.grandviewresearch.com/industry-analysis/acute-bacterial-skin-and-skin-structure-infections-absssi-market-report
Transmitted by the IRW-Press News Service of IR-WORLD.com Finanzkommunikation GmbH
The creator of the message is solely responsible for the content of the message or research. This message is not investment advice or a request to enter into specific stock market transactions.