Recce Pharmaceuticals (ASX:RCE) Achieves Phase II Trial Milestone
Trial Success and Preliminary Data
Recce Pharmaceuticals Limited (ASX:RCE) has announced the successful dosing of all 30 patients in its Phase II clinical trial of RECCE® 327 topical gel (R327G) for the treatment of Acute Bacterial Skin and Skin Structure Infections (ABSSSI). Preliminary data indicates that patients experienced either a complete cure or significant improvement in infection symptoms following treatment.
Future Plans and Additional Trials
The company expects to deliver the full analysis of Phase II results in Q1 2025 and plans to initiate a Phase III study in Australia during H1 2025. This Phase III study will serve as a registrational trial for the US Food and Drug Administration (FDA) and the Australian Therapeutic Goods Administration (TGA). Furthermore, Recce has received approval to begin a registrational Phase III clinical trial for R327G targeting diabetic foot infections in Indonesia.
Comments from Leadership
James Graham, CEO of Recce Pharmaceuticals, remarked, “R327G has made significant progress over the last year, confirming its safety profile and demonstrating impressive efficacy as a topical gel formulation.” He added that they are looking forward to the full dataset, which is expected to further support R327G’s regulatory evaluation.
Dr Alan W Dunton, Chief Medical Advisor, expressed enthusiasm about the clinical results, stating, “These results demonstrate the potential of R327G to address the ABSSSI market. This milestone marks significant progress in our clinical development journey.”
Market Potential
The global ABSSSI treatment market was valued at USD 7.3 billion in 2018 and is projected to reach USD 26 billion by 2032, highlighting considerable commercial opportunities for Recce Pharmaceuticals in addressing this urgent healthcare challenge.
Motley Fool contributor Abbie Stokes has no position in any of the stocks mentioned. The Motley Fool Australia's parent company Motley Fool Holdings Inc. has no position in any of the stocks mentioned. The Motley Fool Australia has no position in any of the stocks mentioned. The Motley Fool has a disclosure policy. This article contains general investment advice only (under AFSL 400691). Authorised by Scott Phillips.
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