Promising Phase 2 Results For Biodexa's eRapa(TM) Indicates Hope for FAP Patients Who Otherwise Have a 100% Lifetime Risk of Colorectal Cancer

Rhea-AI Summary

Biodexa Pharmaceuticals (NASDAQ:BDRX) reported promising results from a Phase 2 trial of eRapa, a drug aimed at treating familial adenomatous polyposis (FAP). This genetic condition, which almost always leads to colorectal cancer if untreated, currently has no non-surgical treatments. The trial included 30 adults and showed a statistically significant 24% reduction in polyp burden after six months, with an 83% non-progression rate. The Cancer Prevention Research Institute of Texas (CPRIT) awarded a $17 million grant for a Phase 3 study, requiring a $8.5 million match, of which Biodexa has secured $7 million. The 12-month results of the Phase 2 trial will be presented at the InSIGHT conference in Barcelona on June 19-22, and a Phase 3 trial is planned for early 2025.

Positive

• eRapa showed a 24% reduction in polyp burden after six months.
• 83% non-progression rate observed in the Phase 2 trial.
• $17 million grant from CPRIT to support Phase 3 study.
• Biodexa secured $7 million of the $8.5 million required match funding.
• Potential for eRapa to delay or prevent the need for surgery in FAP patients.
• Phase 3 trial expected to start in early 2025.
• eRapa could elevate Biodexa to a commercial organization.

Negative

• Current phase 2 trial results are interim; full 12-month data pending.
• Success of phase 3 trial is important for potential marketing approvals.
• Long-term safety and efficacy of eRapa still needs validation.
• Financial reliance on grants and match funding introduces risk.

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CARDIFF, UK / ACCESSWIRE / June 3, 2024 / Biodexa Pharmaceuticals (NASDAQ:BDRX) just announced promising phase 2 results for its newly in-licensed drug eRapa for treating familial adenomatous polyposis (FAP), a mainly genetic disease of the lower GI tract for which there is currently no remedy except surgical removal of the colon and/or rectum.

In a clinical trial involving 30 adult patients, three groups received the same dose of the drug but with different regimens over a period of 12 months. Safety, tolerability and changes from baseline in polyp burden (measured by the sum of polyp diameters) were evaluated using endoscopic exams.

After the first six months, eRapa appeared to be safe and well-tolerated with a statistically significant 24% reduction (p=0.04) in the total polyp burden compared with baseline, as well as an overall 83% non-progression rate. In other words, the drug has been proven to have a high success rate at stopping the growth of polyps before they get a chance to turn into cancer.

Biodexa claims that no drug before has shown such promise in stalling the progression of this disease. The company plans to announce the 12-month results of the phase 2 trial at the InSIGHT scientific conference in Barcelona on June 19-22.

Understanding FAP

FAP is an inherited disease affecting the gastrointestinal tract. If left untreated, it causes hundreds to thousands of polyps to grow inside the colon or rectum. The condition is typically diagnosed in the early teenage years and results in a nearly 100% lifetime risk of colorectal cancer.

Treatment options are very limited, with the only current remedy for FAP being surgical removal of the colon and/or rectum, a surgery that always results in the lifelong use of a colostomy bag.

With roughly 100,000 individuals in the United States and Europe affected by FAP, there is a considerable need for an effective non-surgical intervention.

Introducing eRapa: A New Hope

In April, Biodexa acquired worldwide exclusive rights to eRapa, a drug that the company hopes will delay or prevent the need for surgery.

eRapa is a proprietary oral tablet formulation of rapamycin, which is known to play a role in regulating cellular metabolism, growth and proliferation - all crucial factors in cancer development. Using nanotechnology and pH-sensitive polymers, Biodexa has designed eRapa to address the poor bioavailability, variable pharmacokinetics and toxicity generally associated with the currently available forms of rapamycin.

The medication can also potentially be used to treat bladder and prostate cancers. Results of an ongoing phase 2 study into bladder cancer are expected to be announced in the second quarter of 2025.

Non-Dilutive Financial Backing And Next Steps

Crucially, the Cancer Prevention Research Institute of Texas (CPRIT) has awarded a $17 million grant to support the phase 3 registrational study of eRapa in FAP. The grant requires a 1 for 2 match and Biodexa recently announced that it secured $7 million, most of the required $8.5 million match, in financing through the exercise of existing warrants, which the company intends to use to advance eRapa through the final clinical stage. A phase 3 trial is expected to start in the first quarter of 2025 which, if successful, is expected to lead to applications for marketing approvals in the U.S. and Europe.

eRapa has the potential to catapult Biodexa from a clinical-stage biotech to a commercial organization, supported by non-dilutive grant funding for a devastating disease that currently has no FDA-approved drugs.

All eyes are now on the upcoming 12-month results of the phase 2 trial to be announced later this month, and the subsequent phase 3 trial next year.

Click here for more information on Biodexa Pharmaceuticals.

Featured photo by National Cancer Institute on Unsplash.

Contact:

Stephen Stamp, CEO, CFO
ir@biodexapharma.com

SOURCE: Biodexa Pharmaceuticals Plc

View the original press release on accesswire.com

FAQ

What are the recent results of Biodexa's Phase 2 trial for eRapa?

Biodexa reported a 24% reduction in polyp burden and an 83% non-progression rate after six months in their Phase 2 trial for eRapa.

When will Biodexa announce the 12-month results of the Phase 2 trial for eRapa?

The 12-month results will be presented at the InSIGHT scientific conference in Barcelona on June 19-22, 2024.

What funding has Biodexa received for the Phase 3 trial of eRapa?

Biodexa received a $17 million grant from the Cancer Prevention Research Institute of Texas, requiring an $8.5 million match, of which $7 million has been secured.

When is the Phase 3 trial for eRapa expected to start?

The Phase 3 trial for eRapa is expected to start in the first quarter of 2025.

What is the potential impact of eRapa on Biodexa's business?

If successful, eRapa could transform Biodexa from a clinical-stage biotech to a commercial organization.