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June 10, 2024 Biodexa Pharmaceuticals PLC(“Biodexa” or the “Company”) Twelve month Phase 2 Clinical Trial Results of eRapa™ in Familial Adenomatous Polyposis (FAP) to be Presented at Prestigious Biennial InSIGHT 2024 Meeting in Barcelona Biodexa Pharmaceuticals PLC, (Nasdaq: BDRX), an acquisition-focused clinical stage biopharmaceutical company developing a pipeline of innovative products for the treatment of diseases with unmet medical needs, announces that 12 month data of a Phase 2 clinical trial of eRapa in Familial Adenomatous Polyposis (“FAP”) are to be presented at the prestigious biennial InSIGHT 2024 meeting in Barcelona, Spain on June 22, 2024.
2024年6月10日Biodexa Pharmaceuticals PLC(“Biodexa”或“公司”)将在巴塞罗那Biodexa Pharmaceuticals PLC(Nasdaq:BDRX)举行的著名的InSIGHT 2024两年期会议上提交eRapa™治疗家族性腺瘤性息肉病(FAP)的12个月2期临床试验结果,该公司是一家专注于收购的临床阶段生物制药公司,开发了一系列创新产品,用于治疗未满足医疗需求的疾病,宣布eRapa治疗家族性腺瘤性息肉病(FAP)的2期临床试验的12个月数据将于2024年6月22日在西班牙巴塞罗那举行的著名的InSIGHT 2024两年期会议上提交。
Carol Burke, MD, the Principal Investigator, will present the six and 12 month data (NCT04230499) in an oral presentation at the meeting. Dr Burke presented the six-month data at the Digestive Disease Weekly meeting in Washington D.C. on May 21, 2024. eRapa in FAPFAP is characterized as a proliferation of polyps in the GI tract, usually occurring in mid-teens.
首席研究员卡罗尔·伯克医学博士将在会议上口头介绍六个月和十二个月的数据(NCT04230499)。伯克博士于2024年5月21日在华盛顿举行的消化系统疾病周会上介绍了这六个月的数据。FAPFAP中的eRapa的特征是胃肠道息肉的增殖,通常发生在青少年中期。
There is no approved therapeutic option for treating FAP patients, for whom active surveillance and surgical resection of the colon and/or rectum remain the standard of care. If untreated, FAP typically leads to cancer of the colon and/or rectum. There is a significant hereditary component to FAP with a reported incidence of one in 5,000 to 10,000 in the US2 and one in 11,300 to 37,600 in Europe3.
目前还没有批准的治疗FAP患者的治疗选择,对于FAP患者,主动监测和结肠和/或直肠的手术切除仍然是护理的标准。如果不治疗,FAP通常会导致结肠癌和/或直肠癌。FAP具有重要的遗传成分,据报道,美国2的发病率为5000至10000分之一,欧洲3的发病率为11300至37600分之一。
eRapa has received Orphan Designation in the US with plans to seek such designation in Europe. Importantly, mTOR has been shown to be over-expressed in FAP polyps – thereby underscoring the rationale for using a potent and safe mTOR inhibitor like eRapa to treat FAP. Results of the Phase 2 study at six monthsIn the duodenum, 14/18 (78%) patients were non-progressors with.
eRapa已在美国获得孤儿指定,并计划在欧洲寻求此类指定。重要的是,mTOR已被证明在FAP息肉中过度表达,从而强调了使用有效且安全的mTOR抑制剂(如eRapa)治疗FAP的基本原理。结果在十二指肠6个月的2期研究中,14/18(78%)患者为非进展患者。