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Biodexa Pharmaceuticals | 6-K: Report of foreign private issuer [Rules 13a-16 and 15d-16]

Biodexa Pharmaceuticals | 6-K: Report of foreign private issuer [Rules 13a-16 and 15d-16]

Biodexa Pharmaceuticals | 6-K：外國發行人報告
美股sec公告 ·  06/24 20:50
牛牛AI助理已提取核心訊息
Biodexa Pharmaceuticals PLC, a clinical stage biopharmaceutical company, announced positive results from a Phase 2 clinical trial of eRapa™ for the treatment of Familial Adenomatous Polyposis (FAP). The trial, which was partially funded by a $3 million grant from the Cancer Prevention and Research Institute of Texas (CPRIT), reported a 75% non-progression rate at 12 months and a median decrease in overall polyp burden of 17%. Notably, Cohort 2 showed an 81% non-progression rate and a 29% median decrease in polyp burden. These results were presented by Dr. Carol Burke at the 2024 InSIGHT bi-annual meeting in Barcelona. The Phase 3 study of eRapa in FAP will be supported by a $17 million CPRIT grant. eRapa, a proprietary oral tablet formulation of rapamycin, is designed to improve bioavailability...Show More
Biodexa Pharmaceuticals PLC, a clinical stage biopharmaceutical company, announced positive results from a Phase 2 clinical trial of eRapa™ for the treatment of Familial Adenomatous Polyposis (FAP). The trial, which was partially funded by a $3 million grant from the Cancer Prevention and Research Institute of Texas (CPRIT), reported a 75% non-progression rate at 12 months and a median decrease in overall polyp burden of 17%. Notably, Cohort 2 showed an 81% non-progression rate and a 29% median decrease in polyp burden. These results were presented by Dr. Carol Burke at the 2024 InSIGHT bi-annual meeting in Barcelona. The Phase 3 study of eRapa in FAP will be supported by a $17 million CPRIT grant. eRapa, a proprietary oral tablet formulation of rapamycin, is designed to improve bioavailability and reduce toxicity. The drug has received Orphan Designation in the US, with plans to seek the same in Europe. Biodexa's CEO, Stephen Stamp, expressed optimism that the Phase 2 results, if confirmed in Phase 3, could delay or eliminate the need for surgical resection in FAP patients. The upcoming Phase 3 registrational study will be a double-blind placebo-controlled trial involving approximately 140 high-risk FAP patients.
臨床階段生物製藥公司Biodexa Pharmaceuticals PLC宣佈了eRapa™用於治療家族性腺瘤性息肉病（FAP）的2期臨床試驗的積極結果。該試驗部分資金來自得克薩斯州癌症預防和研究研究所（CPRIT）的300萬美元補助金，報告了在12個月內75%的非進展率和總息肉負擔中位數下降17%。值得注意的是，Cohort 2表現出81%的無進展率和29%的息肉負擔中位數下降。這些結果由Carol Burke博士在2024年巴塞羅那InSIGHT雙年會上宣佈。eRapa在FAP的3期研究將獲得1700萬美元的CPRIT撥款支持。一種專有的雷帕黴素口服片劑製劑eRapa，旨在提高生物利用度並...展開全部
臨床階段生物製藥公司Biodexa Pharmaceuticals PLC宣佈了eRapa™用於治療家族性腺瘤性息肉病（FAP）的2期臨床試驗的積極結果。該試驗部分資金來自得克薩斯州癌症預防和研究研究所（CPRIT）的300萬美元補助金，報告了在12個月內75%的非進展率和總息肉負擔中位數下降17%。值得注意的是，Cohort 2表現出81%的無進展率和29%的息肉負擔中位數下降。這些結果由Carol Burke博士在2024年巴塞羅那InSIGHT雙年會上宣佈。eRapa在FAP的3期研究將獲得1700萬美元的CPRIT撥款支持。一種專有的雷帕黴素口服片劑製劑eRapa，旨在提高生物利用度並減少毒性。該藥物在美國已獲得孤兒藥物認證，計劃在歐洲尋求同樣認證。Biodexa的CEO Stephen Stamp表示，如果第3期的結果證實2期結果，將會推遲或消除FAP患者手術切除的需要。即將到來的第3期註冊研究將是一項雙盲安慰劑對照試驗，涉及約140名高風險FAP患者。

該公告為獨立文件：

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譯文內容由第三人軟體翻譯。


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