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Recce Pharmaceuticals’ synthetic gel successfully treated a range of skin infections in a phase 2 trial, leading the Australian biotech to point to the anti-infective's potential to counter antimicrobial resistance, a growing global threat.

A total of 27 out of the 29 evaluated patients (93%) who received the topical gel, dubbed R327G, for 14 days hit the primary efficacy endpoint in the trial, Recce said in a Feb. 19 release. The patients all had some form of acute bacterial skin and skin structure infections (ABSSSI), including some with diabetic foot infections.

R327G was also shown to be safe and well tolerated, with no serious adverse events reported, hitting another of the study’s endpoints.

“These impressive results underscore the potential of our topical gel to meet critical unmet medical needs in infection treatment,” Recce CEO James Graham said in the release. “As we advance towards registrational phase 3 trials in Indonesia and Australia, we are encouraged by the rapid efficacy and strong safety outcomes demonstrated in this study.”

As well as diabetic foot infections, ABSSSIs can also include a flesh-eating infection called necrotizing fasciitis, and post-operative wound infections. The global market for these combined conditions is expected to reach $26 billion by 2032, according to Recce.

Despite the growing threat of antibiotic resistance, whereby bacteria have evolved to evade older antibiotics meaning new ones need to be created, the low return on investment means many of the biggest biopharmas have given up working on new antifungals or antibiotics in recent years—although GSK in particular has continued to sign deals and post encouraging clinical results against infections like gonorrhea.

In this morning’s release, Recce noted that its phase 2 data “aligns with the FDA’s increased demand for novel broad-spectrum antibiotics (such as R327G) to address antimicrobial resistance.” The Sydney, Australia-based biotech is pitching R327 as both an intravenous and topical therapy that can take on life-threatening infections from Gram-positive and Gram-negative bacteria, including in their superbug forms.

Beyond R327, Recce’s pipeline of synthetic polymer anti-infectives also consists of R435 for bacterial infections and R529 for viral infections.

“These results reflect the broad-spectrum nature and rapid onset of the effect of R327G, which positions us well for the upcoming phase 3 trials in Indonesia and Australia,” Recce’s Chief Medical Officer Alan Dunton, M.D., said in the release. “Importantly, Recce has also demonstrated that its R327 anti-infective compounds are effective in vitro against diverse species of bacteria, including over 500 clinical isolates, many of which were previously considered drug-resistant.”

Read the full article here: https://www.fiercebiotech.com/biotech/australian-biotechs-synthetic-gel-treats-skin-infections-phase-2-trial

Australian biotech points to potential superbug use as gel treats skin infections in phase 2 trial