Recce Pharmaceuticals Ltd has announced encouraging interim results from its Phase II clinical trial of RECCE® 327 Gel (R327G) in patients with acute bacterial skin and skin structure infections (ABSSSI), including diabetic foot infections (DFI). The independent non-Data Safety Monitoring Board (non-DSMB) review of safety and efficacy data supported the continuation of the trial, citing the absence of serious adverse events and promising efficacy.
Positive Efficacy and Safety Profile
The interim data revealed that all patients who completed the treatment with R327G met the primary endpoint, achieving either complete cure or significant improvement. Some patients experienced these positive outcomes within just 7 days, as measured by the Lipsky Clinical Resolution of Infection Scale. The conditions treated included diabetic foot ulcers, eczema, scratches, and puncture wound infections. A wide variety of infecting bacteria (Gram positive and Gram negative) were isolated and successfully treated with improvement/cure of infection in all patients that continued with their treatment.
Professor Eugene Athan, Coordinating Principal Investigator of the study, stated, "We’re seeing some very promising results from the interim data in the Phase II trial, which confirm the safety and potential efficacy of R327G in treating ABSSSI, including diabetic foot infections."
Non-DSMB Recommendation
The non-DSMB's assessment found no safety concerns, leading to a unanimous recommendation to continue the clinical trial, which is anticipated to conclude by the end of the year. One patient was discontinued due to pain at the wound site, which was judged to be unlikely related to R327G.
James Graham, Chief Executive Officer of Recce Pharmaceuticals, commented, “We are extremely encouraged by the feedback from the non-Data Safety Monitoring Board and the profile of R327G. The absence of serious adverse events, coupled with the wide range of broad-spectrum efficacy across challenging wound infections, reinforces the potential of R327G to address unmet medical needs in the treatment of serious bacterial infections.”
Trial Design and Patient Outcomes
The Phase II clinical trial (ACTRN12624000973516) is an open-label, pilot efficacy study evaluating the systemic bioavailability of single and multiple doses of R327G when applied topically to ABSSSI. The trial is designed to assess both the efficacy and systemic absorption of the topical gel.
Market Opportunity
The global ABSSSI treatment market was valued at $7.3 billion USD in 2018 and is projected to reach $26 billion USD by 2032, representing a CAGR of 9.5% between 2019 and 2032.
