Biodexa Moves Into Phase 3 With eRapa For FAP With First Patients Enrolled
Rhea-AI Summary
Biodexa Pharmaceuticals (NASDAQ:BDRX) has initiated its Phase 3 trial for eRapa, a proprietary encapsulated rapamycin treatment for familial adenomatous polyposis (FAP). The company received an additional $3 million grant from the Cancer Prevention & Research Institute of Texas, bringing total non-dilutive funding to $20 million for the Phase 3 trial.
The Phase 2 trial showed promising results with a 29% median decrease in polyp burden and 89% non-progression rate at 12 months in cohort 2. The Phase 3 study will involve 168 patients across approximately 30 clinical sites in the U.S. and Europe. With Fast Track status and Orphan Drug designation, Biodexa is positioned to be first-to-market in an estimated $7.3 billion addressable market with no current therapeutic options.
Positive
- Secured total non-dilutive funding of $20 million for Phase 3 trial
- Achieved 29% median decrease in polyp burden and 89% non-progression rate in Phase 2 cohort 2
- Obtained both FDA Fast Track status and EU Orphan Drug designation
- Potential first-mover advantage in $7.3B addressable market with no current therapeutic options
- Secured market exclusivity for 7 years in US and 10 years in Europe upon launch
Negative
- Small market capitalization of only $3.5M suggests significant financing needs ahead
- Faces potential competition from Recursion Pharmaceuticals and Tempest Therapeutics in Phase 2 trials
- Complex Phase 3 trial requiring coordination across 30 clinical sites in US and Europe
News Market Reaction
On the day this news was published, BDRX declined 5.84%, reflecting a notable negative market reaction. Argus tracked a peak move of +9.4% during that session. Argus tracked a trough of -24.2% from its starting point during tracking. Our momentum scanner triggered 16 alerts that day, indicating notable trading interest and price volatility. This price movement removed approximately $219K from the company's valuation, bringing the market cap to $4M at that time. Trading volume was exceptionally heavy at 18.6x the daily average, suggesting significant selling pressure.
Data tracked by StockTitan Argus on the day of publication.
On Track To Be First Mover In
By: Benzinga Staff Writer
CARDIFF, UK / ACCESS Newswire / September 8, 2025 / Biodexa Pharmaceuticals PLC. (NASDAQ:BDRX), a late clinical-stage biopharmaceutical company developing a pipeline of innovative products for the treatment of diseases with unmet medical needs, has launched its registrational Phase 3 trial of eRapa - its proprietary encapsulated form of rapamycin being developed for the treatment of familial adenomatous polyposis (FAP), a debilitating disease of the lower GI tract.
This post was written and published as a collaboration between the in-house editorial team at Benzinga and Biodexa Pharmaceuticals PLC. with financial support from Biodexa. The two organizations work to ensure that any and all information contained within is true and accurate as of the date hereof to the best of their knowledge and research. This content is for informational purposes only and not intended to be investing advice.
Multiple Key Milestones So Far in 2025
The company just enrolled the first patients in the Phase 3 trial. Earlier this year, its collaboration partner, Rapamycin Holdings, Inc., which does business as Emtora Biosciences, was awarded an additional
All three milestones put the company in a clear leadership position in advancing a drug that could bring relief to people suffering from this largely genetic disease.
A Rare Disease But A
FAP causes hundreds or thousands of precancerous polyps to grow throughout the lower gastrointestinal tract. 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. People with FAP, which usually appears in the patient's mid-teens, end up eventually having their entire colon and rectum removed. If left untreated, there is a near
Biodexa Pharmaceuticals (BDRX) | |
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ADSs outstanding | 619,523 |
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There are reported prevalence's of FAP of one in 5,000 to 10,000 population in the U.S. and one in 11,300 to 37,600 population in Europe. Based on the lowest estimates of prevalence of 1/10,000 and 1/37,600 in the US and Europe, respectively, the adult populations in each territory of approximately 258 million and 358 million and the median annual cost of approved non-biologic orphan drugs in the US of
eRapa Could Have First Mover Advantage
Treating FAP has proven difficult over the years. While Pfizer Inc.'s (PFE) Celecoxib (Celebrex), a Cox-2 inhibitor, was approved to reduce the number of polyps for FAP about eight years ago, it failed a post approval study and the label was pulled. Recursion Pharmaceuticals, Inc. (RXRX) is developing REC-4881 and Tempest Therapeutics Inc (TPST) is developing TPST-1495, both for FAP and both are in Phase 2. Biodexa, with compelling Phase 2 data in hand, is already in Phase 3 and could have first mover advantage in a significant market. Orphan drug designation provides market exclusivity for eRapa of 7 years and 10 years from launch in the U.S. and Europe, respectively.
Phase 3 Trial Fueled By Additional Grant On Back Of Compelling Phase 2 Data
Biodexa's Phase 3 trial is a double-blind, placebo-controlled trial in 168 patients, randomized 2:1 drug to placebo. It is expected that the study will be conducted in approximately 30 clinical sites across the U.S. and Europe. The U.S. component of the study is being managed by LumaBridge, and the European component by Precision for Medicine LLC.
The Phase 3 trial advanced after Biodexa completed a Phase 2 trial that demonstrated a
On the back of the Phase 2 data, the Cancer Prevention & Research Institute of Texas (CPRIT) initially awarded a
Featured image from Shutterstock.
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ir@biodexapharma.com
Important notice, please read: The information and statistical data contained herein may contain forward-looking statements that reflect the company's intentions, expectations, assumptions, or beliefs concerning future events, including, but not limited to, expectations with respect to FDA and other regulatory bodies approval of new products, technology, and product development milestones, the ability of the company to leverage its product development and negotiate favorable collaborative agreements, the commencement of sales, the size of market opportunities with respect to the company's product candidates and sufficiency of the company's cash flow for future liquidity and capital resource needs and other risks identified in the Risk Factor Section of the company's Annual Report and any subsequent reports filed with the SEC. We do not undertake to advise you as to any change in this information. The forward-looking statements are qualified by important factors that could cause actual results to differ materially from those in the forward-looking statements. In addition, significant fluctuations in quarterly results may occur as a result of varying milestone payments and the timing of costs and expenses related to the company's research and development programs. This is not a solicitation of any offer to buy or sell. Redington, Inc. is paid by Biodexa Pharmaceuticals PLC to provide investor relations services, and its employees or members of their families may from time to time own an equity interest in companies mentioned herein.
SOURCE: Biodexa Pharmaceuticals
View the original press release on ACCESS Newswire
FAQ
What are the Phase 3 trial details for Biodexa's (BDRX) eRapa treatment?
What were the Phase 2 results for Biodexa's (BDRX) eRapa in FAP treatment?
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What is the market potential for Biodexa's (BDRX) eRapa FAP treatment?
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