eRapa™ Phase 2 FAP Trial Results Presented at 2024 InSIGHT Meeting

June 10, 2024 - Biodexa Pharmaceuticals, a clinical-stage biopharmaceutical company listed on NASDAQ under the symbol BDRX, is set to present its latest findings from a Phase 2 clinical trial of eRapa™ in treating Familial Adenomatous Polyposis (FAP). These results will be featured at the renowned biennial InSIGHT 2024 meeting in Barcelona, Spain, on June 22, 2024.

Carol Burke, MD, the Principal Investigator of the study, will present both six and 12-month data from the trial (NCT04230499) during the meeting. Previously, Dr. Burke had showcased the six-month data at the Digestive Disease Weekly meeting in Washington D.C. on May 21, 2024.

Understanding FAP and eRapa

Familial Adenomatous Polyposis is a condition marked by the growth of numerous polyps in the gastrointestinal (GI) tract, often beginning in adolescence. If left untreated, these polyps can lead to colorectal cancer. Currently, there is no approved treatment for FAP, with active monitoring and surgical removal of the colon and/or rectum being the standard care. FAP has a notable hereditary component, with its occurrence reported at one in 5,000 to 10,000 people in the US and one in 11,300 to 37,600 in Europe. eRapa has received Orphan Designation in the US, and efforts are underway to secure a similar designation in Europe. The overexpression of mTOR in FAP polyps provides a strong rationale for using eRapa, a potent and safe mTOR inhibitor, to treat the condition.

Phase 2 Study Outcomes at Six Months

The Phase 2 study results at six months revealed encouraging data. In the duodenum, 78% (14 out of 18) of patients were non-progressors, with 61% (11 out of 18) showing partial response (PR). In the colorectum, 86% (25 out of 29) of patients were non-progressors, including all patients with an intact colon, with 67% (15 out of 29) showing PR. Only two drug-related Grade 3 Serious Adverse Events were observed, with no Grade 4 or 5 events reported. Impressively, 97% of patients continued treatment at the six-month mark. Overall, eRapa was found to be safe and well-tolerated, with a significant 24% reduction in total polyp burden compared to the baseline (p=0.04) and an 83% non-progression rate.

About eRapa

eRapa is an oral tablet formulation of rapamycin, also known as sirolimus, which functions as an mTOR inhibitor. mTOR plays a crucial role in the signaling pathways regulating cellular metabolism, growth, and proliferation and is activated during tumorigenesis. Rapamycin is currently approved in the US for preventing organ rejection in renal transplantation as Rapamune® (Pfizer). eRapa leverages nanotechnology and pH-sensitive polymers to address the limitations of rapamycin, such as poor bioavailability, variable pharmacokinetics, and toxicity. The formulation is protected by several patents extending through 2035, with additional patents pending to further extend protection beyond 2035.

About Biodexa Pharmaceuticals

Biodexa Pharmaceuticals PLC is dedicated to developing innovative products for treating diseases with unmet medical needs. In addition to eRapa, the company is working on tolimidone for type 1 diabetes and MTX110 for aggressive rare/orphan brain cancers. Biodexa, headquartered in Cardiff, UK, focuses on enhancing the bio-delivery and bio-distribution of drugs through its proprietary drug delivery technologies.

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