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Biodexa's Licensor Emtora To Announce Phase 2 Clinical Trial Results Of ERapa In Familial Adenomatous Polyposis To Be Presented At Prestigious 2024 Digestive Disease Week Annual Meeting

Biodexa's Licensor Emtora To Announce Phase 2 Clinical Trial Results Of ERapa In Familial Adenomatous Polyposis To Be Presented At Prestigious 2024 Digestive Disease Week Annual Meeting

Biodexa的许可方Emtora将公布eRapa在家族性腺瘤性息肉中的2期临床试验结果,将在久负盛名的2024年消化疾病周年会上公布
Benzinga ·  04/30 11:53

Biodexa's Licensor Emtora to Announce Phase 2 Clinical Trial Results of eRapa in Familial Adenomatous Polyposis to be Presented at Prestigious 2024 Digestive Disease Week Annual Meeting

Biodexa的许可方Emtora将公布eRapa在家族性腺瘤性息肉病中的2期临床试验结果,将在久负盛名的2024年消化疾病周年会上公布

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, is pleased to announce that's its licensor Emtora Biosciences has announced that results of a Phase 2 clinical trial of eRapa in Familial Adenomatous Polyposis ("FAP") are to be presented at the prestigious 2024 Digestive Disease Week annual meeting in Washington DC on May 18-21, 2024. Carol Burke, MD, the Principal Investigator, will present the six month data (NCT04230499) in an oral presentation at the meeting.

Biodexa Pharmicals PLC(纳斯达克股票代码:BDRX)是一家专注于收购的临床阶段生物制药公司,正在开发一系列用于治疗医疗需求未得到满足的疾病的创新产品。该公司很高兴地宣布,其许可方Emtora Biosciences宣布,eRapa治疗家族性腺瘤性息肉病(“FAP”)的2期临床试验结果将在久负盛名的会议上公布 2024 年消化系统疾病周年会将于 2024 年 5 月 18 日至 21 日在华盛顿特区举行。首席研究员卡罗尔·伯克医学博士将在会议上的口头陈述中介绍六个月的数据(NCT04230499)。

On April 26, 2024, Biodexa announced that it had entered into a definitive agreement with a Emtora for the rights to eRapa under an exclusive, worldwide license (with the ability to grant sublicenses) to develop, manufacture, commercialize and otherwise advance the clinical potential of eRapa.

2024年4月26日,Biodexa宣布已与Emtora签订了最终协议,根据独家全球许可(能够授予分许可)获得eRapa的权利,以开发、制造、商业化和以其他方式推进eRapa的临床潜力。

About eRapa
eRapa is a proprietary oral tablet formulation of rapamycin, also known as sirolimus. Rapamycin is an mTOR (mammalian Target Of Rapamycin) inhibitor. mTOR has been shown to have a significant role in the signalling pathway that regulates cellular metabolism, growth and proliferation and is activated during tumorgenesis1. Rapamycin is approved in the US for organ rejection in renal transplantation as Rapamune(Pfizer). Through the use of nanotechnology and pH sensitive polymers, eRapa is designed to address the poor bioavailability, variable pharmacokinetics and toxicity generally associated with the currently available forms of rapamycin. eRapa is protected by a number of issued patents which extend through 2035, with other pending applications potentially providing further protection beyond 2035.

关于 eRapa
eRapa 是雷帕霉素(也称为西罗莫司)的专有口服片剂配方。雷帕霉素是一种 mTOR(哺乳动物雷帕霉素靶标)抑制剂。mTOR 已被证明在调节细胞代谢、生长和增殖的信号通路中具有重要作用1。雷帕霉素在美国获准作为雷帕蒙(辉瑞)用于肾移植中的器官排斥反应。通过使用纳米技术和对pH敏感的聚合物,eRapa旨在解决与当前可用的雷帕霉素相关的低生物利用度、可变的药代动力学和毒性问题。eraPA受多项已颁发的专利保护,这些专利将持续到2035年,其他待处理的申请可能会在2035年之后提供进一步的保护。

eRapa in FAP
FAP is characterized as a proliferation of polyps in the colon and/or rectum, usually occurring in mid-teens. 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. 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.

AFP 中的 eRapa
FAP 的特征是息肉在结肠和/或直肠增生,通常发生在青少年中期。目前尚无经批准的治疗FAP患者的治疗方案,对他们来说,结肠和/或直肠的积极监测和手术切除仍然是治疗的标准。如果不进行治疗,FAP 通常会导致结肠和/或直肠癌。FAP具有重要的遗传成分,据报道,美国的发病率为每5,000至10,000人中就有一人2,在欧洲为11,300至37,600人中有1例3。eRapa已在美国获得孤儿称号,并计划在欧洲寻求这种认定。重要的是,mTOR已被证明在FAP息肉中过度表达,从而突显了使用像eRapa这样的强效安全的mTOR抑制剂来治疗FAP的理由。

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