Recce Pharmaceuticals Commences Phase 3 Trial of Topical Gel for Diabetic Foot Infections

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Recce Pharmaceuticals Commences Phase 3 Trial of Topical Gel for Diabetic Foot Infections

Small Caps2025-09-25

Recce Pharmaceuticals (ASX: RCE) has commenced patient dosing for a registrational Phase 3 clinical trial of its RECCE 327 topical gel (R327G) to treat diabetic foot infections (DFI). The company has ...

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class=\"title\">\nRecce Pharmaceuticals Commences Phase 3 Trial of Topical Gel for Diabetic Foot Infections\n</h2>\n\n<h4 class=\"meta\">\n\n\n2025-09-25 10:43 GMT+8&nbsp;&nbsp;&nbsp;<a href=https://smallcaps.com.au/recce-pharmaceuticals-commences-phase-3-trial-topical-gel-diabetic-foot-infections/><strong>Small Caps</strong></a>\n\n\n</h4>\n\n</header>\n<article>\n<div>\n<p>Recce Pharmaceuticals (ASX: RCE) has commenced patient dosing for a registrational Phase 3 clinical trial of its RECCE 327 topical gel (R327G) to treat diabetic foot infections (DFI).\nThe company has ...</p>\n\n<a href=\"https://smallcaps.com.au/recce-pharmaceuticals-commences-phase-3-trial-topical-gel-diabetic-foot-infections/\">Source Link</a>\n\n</div>\n\n\n</article>\n</div>\n</body>\n</html>\n","isBrief":false,"type":0,"news_type":1,"symbol":"BK7096","symbol_name":"制药","start_time":0,"source_url":"https://smallcaps.com.au/recce-pharmaceuticals-commences-phase-3-trial-topical-gel-diabetic-foot-infections/","article_id":"2570056420","we_media_id":null,"thumbnails":["https://cdn.shortpixel.ai/client/w_868,q_lossy,to_auto,ret_wait/https://150309019.v2.pressablecdn.com/wp-content/uploads/2025/09/Recce-Pharmaceutical-ASX-RCE-Phase-3-Trial-opical-Gel-Diabetic-Foot-Infections.jpg"],"rights":{"source":"smallcap_stock","url":"https://smallcaps.com.au/recce-pharmaceuticals-commences-phase-3-trial-topical-gel-diabetic-foot-infections/","rn_cache_url":null,"directOrigin":true},"url":"https://stock-news.laohu8.com/highlight/detail?id=2570056420","pubTimestamp":1758768202,"columns":[],"sourceInfo":{"source_id":"smallcap_stock","name":"Small Caps"},"weMediaInfo":null,"summary":"Recce Pharmaceuticals has commenced patient dosing for a registrational Phase 3 clinical trial of its RECCE 327 topical gel  to treat diabetic foot infections .The company has activated five clinical study sites across one of the world’s largest DFI patient populations in Indonesia, where estimates place the prevalence of diabetes at 20.9 million adults or approximately 11.3% of the nation’s adult population.Recce expects to meet a “highly statistically-significant positive endpoint” after the dosing the first 155 patients in the Phase 3 trial, which the Indonesian and Australian governments as well as Indonesian biomedical collaborator PT Etana are supporting.Up to 310 patients in the randomised trial will receive either R327G or placebo, with the primary objective of assessing clinical responses according to the Lipsky Scale, which the US Food and Drug Administration  recognises as a valid and reliable method for evaluating DFI treatment outcomes.Secondary endpoints include a DFI tot","collect":0,"end_time":0,"defaultTopTitle":"smallcaps.com.au","property":[],"viewcount":null,"language":"en","relate_stocks":{"BK7096":"制药","RCE.AU":"RECCE PHARMACEUTICALS LTD"},"translate_title":"Recce Pharmaceuticals开始外用凝胶治疗糖尿病足感染的3期试验","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"RCE.AU":1},"content_text":"Recce Pharmaceuticals (ASX: RCE) has commenced patient dosing for a registrational Phase 3 clinical trial of its RECCE 327 topical gel (R327G) to treat diabetic foot infections (DFI).\nThe company has activated five clinical study sites across one of the world’s largest DFI patient populations in Indonesia, where estimates place the prevalence of diabetes at 20.9 million adults or approximately 11.3% of the nation’s adult population.\nRecce expects to meet a “highly statistically-significant positive endpoint” after the dosing the first 155 patients in the Phase 3 trial, which the Indonesian and Australian governments as well as Indonesian biomedical collaborator PT Etana are supporting.\nLipsky Scale Responses\nUp to 310 patients in the randomised trial will receive either R327G or placebo, with the primary objective of assessing clinical responses according to the Lipsky Scale, which the US Food and Drug Administration (FDA) recognises as a valid and reliable method for evaluating DFI treatment outcomes.\nSecondary endpoints include a DFI total wound score and safety of R327G, including clinical observations and adverse events.\nThe Indonesian Drug and Food Regulatory Authority’s approved protocol requires an interim analysis of trial results as well as expedited regulatory review status.\nAn independent data management committee aims to complete this analysis and make recommendations early in the new year after which Recce will complete a submission for accelerated approval, with a targeted commercial launch of R327G before end-2026.\nGlobal Rise in Diabetes\nRecce chief executive officer James Graham said the Phase 3 trial was proceeding to plan.\n“R327G is the first potential treatment for DFI and we see ourselves being well-positioned to meet infectious disease challenges amid the global rise in diabetes,” he said.\nThe company previously demonstrated R327G’s clinical efficacy in a Phase 2 trial on patients with acute bacterial skin and skin structure infections (including DFI), with participants reporting the drug as “very well tolerated” with no signs of any serious adverse events.\nThe results aligned with the FDA’s increased demand for novel broad-spectrum antibiotics to address antimicrobial resistance in skin infections.\nMr Graham confirmed that Recce designed the Phase 3 trial with minimal changes in order to replicate the Phase 2 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