RECCE-327

▎药明康德内容团队编辑 Recce Pharmaceuticals公司日前宣布，其在研创新抗生素R327的外用凝胶制剂，在针对急性细菌性皮肤及皮肤结构感染（ABSSSI）的2期临床试验中获得积极数据。数据显示，R327在14天内有效率达到93%，达到研究所有临床终点。 本研究共纳入30例患者，其中29例纳入最终数据分析。1名患者因原有伤口部位疼痛而退出，且被认为与R327治疗无关。 经7天治疗后，接受R327治疗的患者中有86％（25/29）获得临床缓解。14天时，93％的患者（27/29）达到了主要疗效终点。R327显示出良好的安全性和耐受性，未报告严重不良事件（SAE），研究同时达到所有其它临床终点。 R327用于治疗ABSSSI的3期临床试验已经启动，目前它还在注册性3期临床试验中用于治疗糖尿病患者的足部感染（DFI）。鉴于在这项2期研究中的积极结果，专家表示，治疗DFI的3期临床试验有望在今年年底之前获得具有统计学显著的中期结果。 图片来源：123RF R327是一款基于聚合物的广谱抗生素，正被开发用于治疗由革兰氏阳性菌和革兰氏阴性菌引起的严重且可能危及生命的感染，包括针对这些细菌的耐药菌株。它通过影响细菌的能量生成起到杀菌作用，代表着一种新的抗菌机制。 作为创新的赋能者、客户信赖的合作伙伴以及全球健康产业的贡献者，药明康德致力于通过其独有的CRDMO模式，以及其业内领先的感染性疾病新药研发赋能平台，助力全球共同应对AMR这一重大的健康威胁。早在2022年“即刻行动”药明康德健康产业论坛上，AMR就是我们重点关注的方向之一。在2024“世界提高微生物药物耐药性认识周”（World Antimicrobial Resistance Awareness Week）期间，药明康德内容团队就如何解决AMR这一研究健康挑战，分享了业界多位专家的洞见。其中，开发具有创新机制的抗生素，是多位专家提到的重要努力方向之一。期待更多创新抗生素早日获批上市，为解决AMR提供更多工具。 相关阅读：死亡人数即将反超癌症，药物研发却严重滞后，如何应对这一全球健康威胁？ ▲欲了解更多前沿技术在生物医药产业中的应用，请长按扫描上方二维码，即可访问“药明直播间”，观看相关话题的直播讨论与精彩回放 参考资料： [1] Recce Pharmaceuticals Reports Positive Data from Phase II Trial of RECCE® 327 Gel in Acute Bacterial Skin and Skin Structure Infections, Supporting Accelerated Commercialization Pathway. Retrieved February 20, 2025, from https://www.globenewswire.com/news-release/2025/02/19/3028726/0/en/Recce-Pharmaceuticals-Reports-Positive-Data-from-Phase-II-Trial-of-RECCE-327-Gel-in-Acute-Bacterial-Skin-and-Skin-Structure-Infections-Supporting-Accelerated-Commercialization-Path.html 免责声明：药明康德内容团队专注介绍全球生物医药健康研究进展。本文仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。 版权说明：本文来自药明康德内容团队，欢迎个人转发至朋友圈，谢绝媒体或机构未经授权以任何形式转载至其他平台。转载授权请在「药明康德」微信公众号回复“转载”，获取转载须知。 分享，点赞，在看，聚焦全球生物医药健康创新

Recce noted that its phase 2 data “aligns with the FDA’s increased demand for novel broad-spectrum antibiotics to address antimicrobial resistance.”\n 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.”