Approval from Health Canada to expand Serenta Registrational Phase 3 trial in FAP and Update on Serenta Progress
Rhea-AI Summary
Biodexa (Nasdaq: BDRX) received approval from Health Canada to expand its registrational Serenta Phase 3 trial in familial adenomatous polyposis (FAP) into Canada.
The study is recruiting in 29 centers across the US and Europe, with Canada expected to add 3–4 sites. Serenta plans to enroll 168 patients; 73 are enrolled to date.
Positive
- Health Canada approval to expand Serenta Phase 3 FAP trial into Canada
- Serenta recruiting at 29 active clinical centers across US and five European countries
- Canada expected to add 3–4 additional Serenta Phase 3 trial centers
- Serenta Phase 3 trial target enrollment of 168 FAP patients
- 73 FAP patients enrolled in Serenta as of June 29, 2026
- Company reports recent acceleration in Serenta patient enrollment
Negative
- None.
News Market Reaction – BDRX
In the Jun 29 session, BDRX declined 2.40%, reflecting a moderate negative market reaction. Argus tracked a peak move of +2.3% during that session. Argus tracked a trough of -14.9% from its starting point during tracking. Our momentum scanner triggered 3 alerts that day, indicating moderate trading interest and price volatility.
Data tracked by StockTitan Argus on the day of publication.
Key Figures
Previous Clinical trial Reports
| Date | Event | Sentiment | 24h Move | Catalyst |
|---|---|---|---|---|
| Feb 04 | Clinical asset license | Positive | -11.0% | Exclusive license of Phase 1–ready OPB-171775 (MTX240) for GIST development. |
| Dec 01 | Serenta enrollment update | Positive | +2.2% | First three European patients enrolled into pivotal Phase 3 Serenta FAP trial. |
| Nov 24 | Serenta site activation | Positive | -1.4% | First European Serenta site activated following EMA clinical trial application approval. |
| Nov 03 | CTA approval Europe | Positive | -2.4% | EMA approval of Serenta Phase 3 CTA and outline of $7B addressable FAP market. |
| Aug 18 | First Serenta patients | Positive | +2.8% | Enrollment of first two patients in pivotal Phase 3 Serenta FAP trial. |
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
Clinical trial updates have produced mixed reactions, with slightly more negative than positive 24-hour moves.
Key Terms
registrational phase 3 clinical
familial adenomatous polyposis medical
standard of care medical
AI-generated analysis. How Rhea-AI works. Not financial advice.
June 29, 2026
Approval from Health Canada to expand Serenta Registrational Phase 3 trial in FAP
and
Update on Serenta Progress
Biodexa Pharmaceuticals PLC (Nasdaq: BDRX) (“Biodexa” or “the Company”), a clinical stage biopharmaceutical company developing innovative products focused on the treatment or prevention of gastrointestinal cancers is pleased to announce that it has received approval from Health Canada to expand its registrational Phase 3 trial in familial adenomatous polyposis (“FAP”) into Canada.
The Phase 3 study, branded Serenta, is already up and running in a total of 29 active recruiting clinical centers spread across the US and five countries in Europe. Canada is expected to add a further three or four new centers.
The Serenta trial is expected to enrol 168 patients. As of today, 73 patients have been enrolled.
Commenting, Stephen Stamp, Chief Executive Officer of Biodexa said “We have seen an acceleration in enrolment in the last few months as the European centers have opened. The addition of Canada underpins our enrolment goals. Serenta has been received positively by clinicians and FAP patients for whom there is currently no approved therapeutic option and life-altering surgery remains standard of care.”
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 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
Tel: +44 (0)29 20480 180
www.biodexapharma.com
For information on the Company’s Early Access Program for eRapa, please contact erapa@tannerpharma.com
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.
