November 24, 2025 Biodexa Activates First European Site for Registrational Phase 3 Serenta Trial in FAP Biodexa Pharmaceuticals PLC (Nasdaq: BDRX) announced today that the University of Bonn, Germany is now actively screening patients for the Phase 3 Serenta clinical trial evaluating eRapa in familial adenomatous polyposis (FAP). This marks the first European site activation for the registrational Serenta trial, representing a major milestone in expanding FAP treatment options to European patients who curr ...

Core Viewpoint - Biodexa Pharmaceuticals has received approval from the European Medicines Agency (EMA) for a Clinical Trial Application (CTA) to initiate the Phase 3 Serenta trial for eRapa in patients with familial adenomatous polyposis (FAP), targeting a significant unmet medical need in a $7 billion market [2][5]. Company Overview - Biodexa Pharmaceuticals PLC is a clinical stage biopharmaceutical company focused on developing innovative treatments for diseases with unmet medical needs, including eRapa for FAP and other programs for type 1 diabetes and rare brain cancers [10][14]. Clinical Trial Details - The Serenta trial is a randomized, double-blind, placebo-controlled Phase 3 study designed to evaluate the safety and efficacy of eRapa in FAP patients, with an expected enrollment of 168 patients in a 2:1 drug to placebo ratio [5]. - The trial will initially take place in Denmark, Germany, the Netherlands, and Spain, with Italy expected to be added later [3][4]. Market Potential - The addressable market for FAP treatment is estimated at $7 billion, highlighting the significant opportunity for Biodexa to be a first mover in this space [5]. Disease Background - Familial adenomatous polyposis (FAP) is a rare inherited disorder that leads to a near-100% lifetime risk of colorectal cancer if untreated, with no approved therapeutic options currently available [7]. - The prevalence of FAP is reported to be between 1 in 5,000 to 10,000 in the US and 1 in 11,300 to 37,600 in Europe, indicating a significant need for effective treatments [7]. Product Information - eRapa is an oral formulation of rapamycin, an mTOR inhibitor, designed to improve bioavailability and reduce toxicity compared to existing forms of rapamycin [8][11].

Core Insights - Biodexa Pharmaceuticals has enrolled the first two patients in its pivotal Phase 3 Serenta trial for eRapa, targeting familial adenomatous polyposis (FAP), a hereditary condition that significantly increases the risk of colorectal cancer [2][3] - The company aims to be the first mover in a $7.3 billion addressable market for FAP treatments, with eRapa being the only drug candidate currently in Phase 3 trials [3][8] Company Overview - Biodexa Pharmaceuticals is a clinical-stage biopharmaceutical company focused on developing innovative treatments for diseases with unmet medical needs, including eRapa for FAP and other products for different conditions [2][10] - The company has received $20 million in grant funding from the Cancer Prevention and Research Institute of Texas (CPRIT) to support the Serenta trial [3][9] Trial Details - The Serenta trial is a double-blind, placebo-controlled study involving 168 patients, with a randomization ratio of 2:1 for drug versus placebo [5] - The trial will be conducted across multiple sites, including 20 in the US and 10 in Europe, managed by LumaBridge and Precision for Medicine, respectively [5] Disease Context - Familial adenomatous polyposis (FAP) is characterized by the development of numerous colorectal polyps and a near-100% lifetime risk of colorectal cancer if untreated, highlighting the urgent need for effective therapies [6] - Current treatment options are limited to surgical interventions, underscoring the significance of developing non-surgical alternatives like eRapa [4][6] Market Opportunity - The estimated addressable market for eRapa in FAP is approximately $7.3 billion, based on prevalence rates and the median annual cost of approved non-biologic orphan drugs [8]

Core Viewpoint - Biodexa Pharmaceuticals has filed a Clinical Trial Application (CTA) with the European Medicines Agency (EMA) for its Phase 3 Serenta trial targeting familial adenomatous polyposis (FAP), a hereditary condition that significantly increases the risk of colorectal cancer if untreated [2][4]. Company Overview - Biodexa Pharmaceuticals PLC is a clinical stage biopharmaceutical company focused on developing innovative treatments for diseases with unmet medical needs, including eRapa for FAP and other conditions [2][11]. - The company has received Fast Track Designation from the FDA and Orphan Drug designation in Europe for its eRapa program [4]. Clinical Trial Details - The Serenta trial (NCT06950385) is a randomized, double-blind, placebo-controlled Phase 3 study aimed at evaluating the safety and efficacy of eRapa in FAP patients [5]. - The trial will initially cover clinical sites in Denmark, Germany, Netherlands, and Spain, with Italy expected to be added later [3]. Funding and Support - The Cancer Prevention and Research Institute of Texas (CPRIT) has awarded $20 million in grant funding to support the eRapa program [4]. - CPRIT has a history of significant investment in cancer research, having awarded $2.9 billion in grants to date [9]. Disease Context - Familial adenomatous polyposis (FAP) is characterized by the development of hundreds to thousands of colorectal polyps, leading to a near-100% lifetime risk of colorectal cancer if untreated [7]. - There is a significant unmet need for effective therapies for FAP, as current treatment options primarily involve surgical resection [7]. Product Information - eRapa is a proprietary oral formulation of rapamycin (sirolimus), an mTOR inhibitor, designed to improve bioavailability and reduce toxicity compared to existing formulations [8][12]. - The product is protected by multiple patents extending through 2035, with additional applications pending [8].

Core Viewpoint - Biodexa Pharmaceuticals has filed a Clinical Trial Application (CTA) with the European Medicines Agency (EMA) for its Phase 3 Serenta trial targeting familial adenomatous polyposis (FAP), a hereditary condition that significantly increases the risk of colorectal cancer if untreated [2][4]. Company Overview - Biodexa Pharmaceuticals PLC is a clinical stage biopharmaceutical company focused on developing innovative treatments for diseases with unmet medical needs, including eRapa for FAP and other conditions [2][11]. - The company has received Fast Track Designation from the FDA and Orphan Drug designation in Europe for its eRapa program [4]. Clinical Trial Details - The Serenta trial (NCT06950385) is a randomized, double-blind, placebo-controlled Phase 3 study aimed at evaluating the safety and efficacy of eRapa in FAP patients [5]. - The trial will initially cover clinical sites in Denmark, Germany, Netherlands, and Spain, with Italy expected to be added later [3]. Funding and Support - The Cancer Prevention and Research Institute of Texas (CPRIT) has awarded $20 million in grant funding to support the eRapa program, contributing to the advancement of the trial [4][9]. Disease Context - Familial adenomatous polyposis (FAP) is characterized by the development of hundreds to thousands of colorectal polyps, leading to a near-100% lifetime risk of colorectal cancer if untreated [7]. - There is a significant unmet need for effective and less invasive therapies for FAP patients, as current treatment options primarily involve surgical resection [7]. Product Information - eRapa is a proprietary oral formulation of rapamycin (sirolimus), an mTOR inhibitor, designed to improve bioavailability and reduce toxicity compared to existing formulations [8][12]. - The product is protected by multiple patents extending through 2035, with additional applications potentially providing further protection [8].

Core Viewpoint - Biodexa Pharmaceuticals has activated the first clinical study site for its Phase 3 Serenta trial targeting familial adenomatous polyposis (FAP), marking a significant milestone in developing a new treatment option for this condition [1][3]. Group 1: Clinical Trial Details - The Serenta trial (NCT06950385) is a randomized, double-blind, placebo-controlled study aimed at evaluating the safety and efficacy of eRapa in individuals diagnosed with FAP [2]. - The first clinical site in the US is now open and actively screening eligible participants for the trial [2]. Group 2: Company Achievements and Support - Biodexa's CEO, Stephen Stamp, highlighted the importance of the first clinical site activation following the Fast Track Designation and a positive Type C Meeting, emphasizing the collaborative efforts with Emtora Biosciences and LumaBridge [3]. - The Cancer Prevention and Research Institute of Texas (CPRIT) has awarded $20 million in grant funding to support the eRapa program, showcasing significant financial backing for the initiative [3][6]. Group 3: Background on Familial Adenomatous Polyposis (FAP) - FAP is a rare inherited disorder characterized by the development of hundreds to thousands of colorectal polyps, with a near-100% lifetime risk of colorectal cancer if untreated [4]. - There is a significant unmet need for effective and less invasive therapies for FAP patients, as current standard care involves active surveillance and surgical resection [4]. Group 4: About eRapa - eRapa is a proprietary oral formulation of rapamycin (sirolimus), an mTOR inhibitor, which plays a crucial role in regulating cellular metabolism, growth, and proliferation [5][8]. - The formulation is designed to improve bioavailability and reduce toxicity associated with existing rapamycin forms, with patent protection extending through 2035 [5][11].

Core Insights - Biodexa Pharmaceuticals PLC has announced the brand name "Serenta" for its upcoming Phase 3 clinical study in Familial Adenomatous Polyposis (FAP) [1][2] - The company has launched a dedicated website, www.serentatrial.com, to provide information and resources for patients, caregivers, and healthcare professionals [1][2] Company Overview - Biodexa is a clinical stage biopharmaceutical company focused on developing innovative products for diseases with unmet medical needs, with its lead programs including eRapa for FAP and Non-Muscle Invasive Bladder Cancer, tolimidone for type 1 diabetes, and MTX110 for aggressive rare/orphan brain cancer [4][8] - eRapa is a proprietary oral tablet formulation of rapamycin, an mTOR inhibitor, designed to improve bioavailability and reduce toxicity associated with existing rapamycin formulations [3][5] - The company utilizes proprietary drug delivery technologies to enhance the bio-distribution of its medicines [8]

Core Viewpoint - Biodexa Pharmaceuticals has received Orphan Drug Designation in Europe for eRapa in familial adenomatous polyposis (FAP), following a similar designation from the FDA in 2019, and is preparing to initiate a Phase 3 study targeting a market opportunity of approximately $7.3 billion [1][2][5]. Company Overview - Biodexa Pharmaceuticals PLC is a clinical stage biopharmaceutical company focused on developing innovative treatments for diseases with unmet medical needs, including eRapa for FAP and other products for type 1 diabetes and rare brain cancers [9][13]. Orphan Drug Designation - The Orphan Drug Designation in the EU is granted by the European Commission based on a positive opinion from the EMA Committee for Orphan Medicinal Products, aimed at encouraging the development of drugs for rare, life-threatening diseases [2]. Phase 3 Study Details - The Phase 3 study of eRapa in FAP will be a double-blind placebo-controlled trial involving 168 patients, with a 2:1 randomization of drug to placebo, conducted across approximately 30 clinical sites in the US and Europe [3]. Market Opportunity - The addressable market for eRapa in FAP is estimated at $7.3 billion, based on the prevalence of FAP and the adult populations in the US and Europe, with a median annual cost of approved non-biologic orphan drugs in the US being $206,176 [5]. FAP Disease Overview - Familial adenomatous polyposis (FAP) is characterized by the proliferation of polyps in the colon and rectum, typically diagnosed in mid-teens, with no approved therapeutic options currently available [4]. eRapa Product Information - eRapa is a proprietary oral formulation of rapamycin, an mTOR inhibitor, designed to improve bioavailability and reduce toxicity compared to existing forms of rapamycin [6][10]. Clinical Study Results - Data from the Phase 2 study of eRapa indicated a median 17% reduction in total polyp burden at 12 months and a 75% non-progression rate, with cohort 2 showing an 89% non-progression rate and a 29% median reduction in polyp burden [7].