Company: BDRX
Filing Date: 2025-08-18
Form Type: 424B3
Source: 0001214659-25-012378
Chunk: 3

Company: Biodexa Pharmaceuticals Plc
Filing Date: 2025-08-18
Form: 424B3
Chunk 3
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 team is committed to advancing eRapa as the first non-surgical treatment for the thousands of patients worldwide suffering from this debilitating disease. We recognize both the responsibility and the opportunity to be the first mover in this $7 billion addressable market. And none of this would have been possible without the support of CPRIT which has awarded $20 million in grant funding to support the program”.

Dr. Marcia Cruz-Correa, Clinical Investigator, added “At Pan American Center for Oncology Trials, we are pleased to be part of the Serenta trial and delighted to be recognized as the first enroller of patients. Its Phase 2 data are promising and, if replicated in the Phase 3 Serenta trial, eRapa could become the first therapeutic treatment for FAP patients who currently have no options other than life-altering surgery”.

eRapa Phase 3 program
The Serenta trial (NCT06950385) is a double-blind placebo-controlled trial in 168 patients, randomized 2:1 drug / placebo to evaluate the safety and efficacy of eRapa in individuals diagnosed with FAP. All study sites have been identified and are in the process of onboarding. The US component of the trial, incorporating 20 sites, is being managed by LumaBridge based in San Antonio, Texas. The European component, comprising 10 sites will be conducted by Precision for Medicine. For more information about the Serenta trial, including eligibility criteria and specific site locations, please visit https://serentatrial.com/

About FAP
Familial adenomatous polyposis is a rare, inherited disorder characterized by the development of hundreds to thousands of colorectal polyps and a near-100% lifetime risk of colorectal cancer if left untreated. There is a significant unmet need for effective, less invasive therapies for FAP patients. 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.. There is a significant hereditary component to FAP with a reported prevalence of one in 5,000 to 10,000 in the US 1and one in 11,300 to 37,600 in Europe 2.

About eRapa

eRapa is a proprietary oral capsule formulation of rapamycin, also known as sirolimus. Rapamycin is