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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 ·  05/21 22:54
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 its drug eRapa in treating Familial Adenomatous Polyposis (FAP). The trial, which was partially funded by a $20 million grant from the Cancer Prevention and Research Institute of Texas, showed an 83% non-progression rate and a statistically significant decrease in overall mean polyp burden at 6 months. The results are scheduled for presentation at the 2024 Digestive Disease Week annual meeting in Washington D.C. The open-label study involved 30 adult patients across seven U.S. centers, with three different dosing cohorts over a 12-month treatment period. The primary endpoints were safety, tolerability, and percentage change from baseline in polyp burden at six months. The drug...Show More
Biodexa Pharmaceuticals PLC, a clinical stage biopharmaceutical company, announced positive results from a Phase 2 clinical trial of its drug eRapa in treating Familial Adenomatous Polyposis (FAP). The trial, which was partially funded by a $20 million grant from the Cancer Prevention and Research Institute of Texas, showed an 83% non-progression rate and a statistically significant decrease in overall mean polyp burden at 6 months. The results are scheduled for presentation at the 2024 Digestive Disease Week annual meeting in Washington D.C. The open-label study involved 30 adult patients across seven U.S. centers, with three different dosing cohorts over a 12-month treatment period. The primary endpoints were safety, tolerability, and percentage change from baseline in polyp burden at six months. The drug was well-tolerated with only two drug-related Grade 3 Serious Adverse Events reported, and 97% of patients remained on treatment at six months. eRapa, a proprietary oral tablet formulation of rapamycin, is designed to improve bioavailability and reduce toxicity. It has received Orphan Designation in the US, with plans to seek the same in Europe. Biodexa Pharmaceuticals, which focuses on developing treatments for diseases with unmet medical needs, also has other products in its pipeline, including treatments for Non Muscle Invasive Bladder Cancer, type 1 diabetes, and rare/orphan brain cancer indications. The company's R&D facility is based in Cardiff, UK.
臨床階段的生物製藥公司Biodexa Pharmaceuticals PLC宣佈了其治療家族性腺瘤性息肉病(FAP)的藥物eRapa的2期臨床試驗取得積極成果。該試驗部分由德克薩斯州癌症預防與研究所的2000萬美元撥款資助,顯示6個月的非進展率爲83%,總體平均息肉負擔在統計學上顯著下降。研究結果計劃在華盛頓特區舉行的2024年消化疾病週年會上公佈。這項開放標籤研究涉及來自美國七個中心的30名成年患者,在12個月的治療期內採用了三種不同的劑量群體。主要終點是安全性、耐受性以及六個月時息肉負擔與基線相比的百分比變化。該藥物耐受性良好,僅報告了兩種與藥物相關的3級嚴重不良事件,97%的患者在六個月...展開全部
臨床階段的生物製藥公司Biodexa Pharmaceuticals PLC宣佈了其治療家族性腺瘤性息肉病(FAP)的藥物eRapa的2期臨床試驗取得積極成果。該試驗部分由德克薩斯州癌症預防與研究所的2000萬美元撥款資助,顯示6個月的非進展率爲83%,總體平均息肉負擔在統計學上顯著下降。研究結果計劃在華盛頓特區舉行的2024年消化疾病週年會上公佈。這項開放標籤研究涉及來自美國七個中心的30名成年患者,在12個月的治療期內採用了三種不同的劑量群體。主要終點是安全性、耐受性以及六個月時息肉負擔與基線相比的百分比變化。該藥物耐受性良好,僅報告了兩種與藥物相關的3級嚴重不良事件,97%的患者在六個月後仍在接受治療。eRapa是雷帕黴素的專有口服片劑,旨在提高生物利用度並降低毒性。它已在美國獲得孤兒稱號,並計劃在歐洲尋求同樣的孤兒稱號。Biodexa Pharmicals專注於爲醫療需求未得到滿足的疾病開發治療方法,其產品還包括非肌肉浸潤性膀胱癌、1型糖尿病和罕見/孤兒腦癌適應症的治療方法。該公司的研發設施位於英國加的夫。

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