June 24, 2024 Biodexa Pharmaceuticals PLC Biodexa Announces Positive Phase 2 Clinical Trial Results of eRapa™ at 12 months in Familial Adenomatous Polyposis (FAP) Overall 75% Non-progression Rate at 12 Months Median Decrease in Overall Polyp Burden at 12 Months of 17% Cohort 2 Non-progression Rate at 12 months of 81% and Median Decrease in Poly Burden of 29% Informs Phase 3 Dosage Regimen Data Reported in Oral Presentation at 2024 Bi-Annual InSIGHT Meeting (DATELINE) JUNE 24 -- Biodexa Pharmaceuticals PLC (“Biodexa” or the “Company”) (Nasdaq: BDRX), an acquisition-focused clinical stage biopharmaceutical company developing a pipeline of innovative products for the treatment of diseases with unmet medical needs, announced that 12 month results of a Phase 2 clinical trial of eRapa™ in Familial Adenomatous Polyposis (“FAP”) (NCT04230499) were reported in an oral presentation at the prestigious 2024 InSIGHT bi-annual meeting in Barcelona by Carol Burke, M.D., a specialist gastroenterologist at the Cleveland Clinic and a leading authority in FAP, a mostly genetic disease of precancerous polyps for which the only current remedy is surgical removal of the colon and/or rectum.

2024年6月24日Biodexa Pharmaceuticals PLC Biodexa宣布eRapa™在家族性腺瘤性息肉病（FAP）12个月时的2期临床试验结果为阳性，12个月时总体无进展率为75%，12个月时总体息肉负担中位数下降17%，队列2 12个月时无进展率为81%，多负担中位数下降29%，这为6月24日在2024年双年度洞察会议（DATELINE）上口头报告的3期剂量方案数据提供了信息。Biodexa Pharmaceuticals PLC（“Biodexa”或“Company”）（纳斯达克：BDRX），一家以收购为重点的临床阶段生物制药公司，正在开发用于治疗疾病的创新产品管道在医疗需求未得到满足的情况下，宣布eRapa™治疗家族性腺瘤性息肉病（“FAP”）的2期临床试验（NCT04230499）的12个月结果由医学博士卡罗尔·伯克（CarolBurke）在巴塞罗那著名的2024 InSIGHT双年度会议上口头报告。，克利夫兰诊所（Cleveland Clinic）的胃肠病专家，FAP（一种主要是癌前息肉的遗传性疾病）的权威人士，目前唯一的治疗方法是手术切除结肠和/或直肠。

The Phase 2 study was partially supported by $3 million in grant funding from the Cancer Prevention and Research Institute of Texas (CPRIT) under product development awards DP22053 and DP190069.   The Phase 3 study of eRapa in FAP is supported by a $17 million grant from CPRIT. Dr. Burke is the Principal Investigator for the both the Phase 2 study and the upcoming Phase 3 registrational study.

第二阶段研究得到了德克萨斯州癌症预防与研究所（CPRIT）在产品开发奖DP22053和DP190069下的300万美元赠款的部分支持。FAP中eRapa的第三阶段研究得到了CPRIT 1700万美元赠款的支持。伯克博士是第二阶段研究和即将到来的第三阶段注册研究的主要研究者。

Stephen Stamp, CEO of Biodexa, said, “The promising Phase 2 results, if confirmed in a registrational Phase 3 study, may delay or potentially obviate the need for resection of the colon and/or rectum in FAP patients.

Biodexa首席执行官斯蒂芬·斯塔姆（StephenStamp）说：“如果在注册的第三阶段研究中得到证实，那么有希望的第二阶段结果可能会延迟或潜在地避免FAP患者切除结肠和/或直肠的需要。