Biodexa Initiates Support Activities for FAP Patients and Treatment Centers in France
Rhea-AI Summary
Biodexa Pharmaceuticals (Nasdaq: BDRX) has initiated new support activities for Familial Adenomatous Polyposis (FAP) patients and prescribers in France, holding its first round table meeting in Paris to facilitate experience-sharing among patients, advocacy groups and clinicians and to inform its goal of improving outcomes and quality of life.
These initiatives build on Biodexa’s global Early Access Program and Named Patient prescribing, which allow clinicians to prescribe its investigational mTOR inhibitor eRapa for FAP outside clinical trials. eRapa has US Orphan Designation, with plans to seek similar status in Europe, and is being advanced into a double‑blind, placebo‑controlled Phase 3 registrational trial in FAP, targeting 30 clinical sites in the US and Europe and 168 patients randomized 2:1. The Phase 3 program is supported by a $20 million grant from the Cancer Prevention and Research Institute of Texas (CPRIT).
Positive
- $20 million CPRIT grant supporting eRapa Phase 3 FAP program
- Planned Phase 3 FAP trial with 168 patients across 30 sites
- eRapa access expanded via global Early Access and Named Patient programs
Negative
- None.
Key Figures
Historical Context
| Date | Event | Sentiment | 24h Move | Catalyst |
|---|---|---|---|---|
| Jun 30 | Annual meeting results | Positive | +3.1% | Most ordinary resolutions passed, with voting majorities ranging from 73% to 94%. |
| Jun 30 | Registered direct offering | Negative | +2.1% | Company priced equity financings totaling approximately $3.5 million. |
| Jun 29 | FAP trial expansion | Positive | -2.4% | Health Canada approved expansion of the Serenta Phase 3 trial into Canada. |
| Jun 17 | AGM postponement | Negative | +1.7% | Annual general meeting was adjourned because the required quorum was not reached. |
| May 14 | Share capital reorganization | Negative | -8.5% | Company proposed a 10,000:1 reverse split and changes to its ADS ratio. |
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
BDRX's reaction diverged from the apparent announcement direction in 3 of the 5 selected historical events.
Key Terms
familial adenomatous polyposis medical
mTOR inhibitor medical
orphan designation regulatory
molecular glue technical
open label medical
AI-generated analysis. How Rhea-AI works. Not financial advice.
July 28, 2026
Biodexa Initiates Support Activities for FAP Patients and Treatment Centers in France
Biodexa Pharmaceuticals PLC (Nasdaq: BDRX), a clinical stage biopharmaceutical company developing innovative products focused on the treatment or prevention of gastrointestinal cancers is pleased to announce that it has held its first round table meeting in Paris, France as part of expanding its support for Familial Adenomatous Polyposis (FAP) patients and prescribers. The sharing of experience and expertise amongst patients, patient advocacy groups and clinicians is informing Biodexa’s goal of improving outcomes and quality of life for FAP patients. These activities will augment Biodexa previous step of making eRapa available for FAP patients via an Early Access Program and Named Patient prescribing. A global initiative which gives clinicians who treat FAP patients the opportunity to prescribe this investigational medicine outside of a clinical trial for the first time.
Commenting, Stephen Stamp, Chief Executive Officer of Biodexa said “We are delighted to be expanding our support for the FAP community and are committed to improving the lives of patients. We are proud to be support clinicians and patients in this way in addition to making eRapa available to clinicians for whom there are no currently approved therapeutic options.”
About Familial Adenomatous Polyposis
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. If untreated, FAP typically leads to cancer of the colon and/or rectum. There is a significant hereditary component to FAP with a reported incidence of one in 5,000 to 10,000 in the US and one in 11,300 to 37,600 in Europe. eRapa has received Orphan Designation in the US with plans to seek such designation in Europe. Importantly, mTOR has been shown to be over-expressed in FAP polyps – thereby underscoring the rationale for using a potent and safe mTOR inhibitor like eRapa to treat FAP.
About eRapa
eRapa is a proprietary oral capsule formulation of rapamycin, also known as sirolimus. Rapamycin is an mTOR (mammalian Target Of Rapamycin) inhibitor. mTOR has been shown to have a significant role in the signalling pathway that regulates cellular metabolism, growth and proliferation and is activated during tumorigenesis. Importantly, mTOR has been shown to be over-expressed in FAP polyps – thereby underscoring the rationale for using a potent and safe mTOR inhibitor like eRapa to treat FAP. Data from an open label Phase 2 trial were presented at Digestive Disease Week and InSIGHT 2024 in May and June 2024, respectively. Based on those data, Biodexa initiated a double-blind, placebo-controlled Phase 3 registrational trial which is planned to initiate 30 clinical sites across the US and Europe and to enrol 168 patients randomized 2:1, drug: placebo. The Phase 3 program is supported by a
The Cancer Prevention and Research Institute of Texas
To date, CPRIT has awarded
About Biodexa Pharmaceuticals PLC
The Company’s lead development programs include eRapa, under development for Familial Adenomatous Polyposis and Non-Muscle Invasive Bladder Cancer, MTX240 under development for Gastrointestinal Stromal Tumors (GIST) and tolimidone, under development for the treatment of type 1 diabetes.
eRapa is a proprietary oral capsule formulation of rapamycin, also known as sirolimus. Rapamycin is an mTOR (mammalian Target Of Rapamycin) inhibitor. mTOR has been shown to have a significant role in the signalling pathway that regulates cellular metabolism, growth and proliferation and is activated during tumorigenesis.
MTX240 is a molecular glue, bringing two intracellular proteins, PDE3a and SLFN12, specifically co-expressed by GIST cancer cells, into close proximity to form a stable complex. This interaction stabilizes SLFN12, enabling it to drive RNase-mediated apoptosis in GIST cells through a mechanism independent of KIT of PDGFR signalling.
Tolimidone is an orally delivered, potent and selective inhibitor of Lyn kinase. Lyn is a member of the Src family of protein tyrosine kinases, which is mainly expressed in hematopoietic cells, in neural tissues, liver, and adipose tissue. Tolimidone demonstrates glycaemic control via insulin sensitization in animal models of diabetes and has the potential to become a first in class blood glucose modulating agent.
Biodexa’s headquarters and R&D facility is in Cardiff, UK. For more information visit www.biodexapharma.com.
For more company information, please contact:
Stephen Stamp, CEO
Fiona Sharp, CFO
Tel: +44 (0)29 20480 180
www.biodexapharma.com
For program information, contact;
https://clinicaltrials.gov/study/NCT07689942?cond=erapa&viewType=Card&rank=2
https://biodexapharma.com/clinical-trials/erapa-encapsulated-rapamycin-named-patient-programme/
Forward-Looking Statements
Certain statements in this announcement may constitute “forward-looking statements” within the meaning of legislation in the United Kingdom and/or United States. Such statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and are based on management’s belief or interpretation. All statements contained in this announcement that do not relate to matters of historical fact should be considered forward-looking statements. In certain cases, forward-looking statements can be identified by the use of words such as “plans”, “expects” or “does not anticipate”, or “believes”, or variations of such words and phrases or statements that certain actions, events or results “may”, “could”, “would”, “might” or “will be taken”, “occur” or “be achieved.” Forward-looking statements and information are subject to various known and unknown risks and uncertainties, many of which are beyond the ability of the Company to control or predict,
that may cause their actual results, performance or achievements to be materially different from those expressed or implied thereby, and are developed based on assumptions about such risks, uncertainties and other factors set out herein.
Reference should be made to those documents that Biodexa shall file from time to time or announcements that may be made by Biodexa in accordance with the rules and regulations promulgated by the SEC, which contain and identify other important factors that could cause actual results to differ materially from those contained in any projections or forward-looking statements. These forward-looking statements speak only as of the date of this announcement. All subsequent written and oral forward-looking statements by or concerning Biodexa are expressly qualified in their entirety by the cautionary statements above. Except as may be required under relevant laws in the United States, Biodexa does not undertake any obligation to publicly update or revise any forward-looking statements because of new information, future events or events otherwise arising.
