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Phase 1b clinical trial of KM-001 demonstrated favorable safety profile and high responder rate of 87% in patients with palmoplantar keratoderma and pachyonychia congenita In vitro and in vivo data of KM-001 and KM-023 demonstrated significant improvements in skin histology and significant reductions in scratching NESS ZIONA, Israel, May 17, 2024 (GLOBE NEWSWIRE) -- Kamari Pharma, a privately-held clinical stage biotechnology company developing first and best-in-class treatments for rare and severe genetic skin diseases, today announced two presentations reporting results for its novel TRPV3 inhibitors, KM-001 (topical) and KM-023 (oral), were given at the 81st Annual Meeting of the Society for Investigative Dermatology (SID) that is taking place May 15-18, 2024 in Dallas, TX, USA.
KM-001的1b期临床试验显示,掌plant角化病和先天性厚甲症患者在体外和体内均具有良好的安全性和87%的高反应率。KM-001和KM-023的数据显示,皮肤组织学有了显着改善,抓挠性显着降低,以色列锡安,2024年5月17日(全球新闻通讯社)——Kamari Pharma是一家私营临床阶段生物技术公司,开发了罕见和严重遗传性皮肤病的一流治疗方法,今天在该协会第81届年会上宣布了其新型TRPV3抑制剂KM-001(局部)和KM-023(口服)的两次报告结果2024年5月15日至18日在美国德克萨斯州达拉斯举行的调查性皮肤病学(SID)。
Below are summaries of the presentations: Poster #LB941: “KM-001, a novel TRPV3 inhibitor, demonstrates safety and preliminary efficacy in Phase 1b clinical study for the treatment of palmoplantar keratoderma” presented by Edel O’Toole, M.D., Ph.D. Professor of Molecular Dermatology and Centre Lead of the Centre for Cell Biology and Cutaneous Research, Blizard Institute, Queen Mary University of London and lead investigator in the study.
以下是介绍摘要:海报#LB941:“KM-001是一种新型TRPV3抑制剂,在治疗掌plant角化病的1b期临床研究中显示出安全性和初步疗效”,由Edel O'Toole医学博士,分子皮肤病学博士教授和伦敦玛丽女王大学Blizard研究所细胞生物学和皮肤研究中心中心负责人和该研究的首席研究员介绍。
Presented results from twelve-week, Phase 1b open-label studies (UK and Israel) assessing 4g/day of KM-001 1% cream applied to each foot twice daily for the treatment of pachyonychia congenita (PC) and punctate palmoplantar keratoderma type 1 (PPPK1). Eight patients in the UK (7 PC;1 PPPK1) and seven patients in Israel (3 PC;4 PPPK1) completed the treatment period.Safety: No drug-related severe adverse events nor systemic side effects were observed.
介绍了为期12周的1b期开放标签研究(英国和以色列)的结果,该研究评估了每天两次将4g/天的KM-001 1%乳膏涂抹在每只脚上,用于治疗先天性厚甲症(PC)和点状掌plant角化病1型(PPPK1)。英国的8名患者(7名患者;1名PPPK1)和以色列的7名患者(3名患者;4名PPPK1)完成了治疗期。安全性:未观察到与药物相关的严重不良事件或全身副作用。
Minimal treatment emergent adverse events occurred (n=11); all were mild and did not lead to patient disconti.
发生最小的治疗紧急不良事件(n=11);所有这些都是轻微的,并没有导致患者的不满。