Promising Phase 2 Results For Biodexa's eRapa(TM) Indicates Hope for FAP Patients Who Otherwise Have a 100% Lifetime Risk of Colorectal Cancer
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.
- 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.
- 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.
Insights
eRapa represents a potential breakthrough for patients with Familial Adenomatous Polyposis (FAP), a genetic condition leading to a nearly inevitable risk of developing colorectal cancer. The phase 2 trial results showing a 24% reduction in polyp burden after six months are statistically significant and suggest that eRapa could delay or even prevent the need for invasive surgical intervention. This is particularly important in FAP cases where current options are limited to surgeries that severely impact the patient's quality of life. The use of pH-sensitive polymers to enhance the drug's bioavailability and minimize its toxicity is a noteworthy innovation. If these results hold through the 12-month analysis and upcoming phase 3 trials, eRapa could become a groundbreaking non-surgical treatment for FAP patients.
The financial backing from the Cancer Prevention Research Institute of Texas (CPRIT) with a $17 million grant is a substantial vote of confidence in eRapa's potential, indicating robust support for the phase 3 trial. Biodexa securing $7 million in financing through existing warrants further strengthens its financial position, reducing the risk of additional equity dilution for current shareholders. The potential market for eRapa is significant, with an estimated 100,000 individuals in the US and Europe affected by FAP. If phase 3 results are positive, this could lead to regulatory approvals and commercial availability, positioning Biodexa as a key player in gastrointestinal oncology treatments. However, investors should be aware of the inherent risks associated with clinical trials and regulatory approvals.
Biodexa's focus on a niche but unmet medical need with eRapa is a strategic move that could pay off significantly. The fact that FAP currently has no FDA-approved drug treatments means that eRapa, if successful, could dominate this market segment. Furthermore, the potential applications of eRapa in treating other cancers like bladder and prostate cancer expand its marketability and revenue potential. The upcoming announcement of the 12-month results at the InSIGHT conference will be crucial. Positive results could not only boost Biodexa's stock but also attract partnerships or acquisition interest from larger pharmaceutical companies looking to bolster their oncology pipelines. Nevertheless, the company must carefully navigate the regulatory landscape and ensure successful completion of the phase 3 trial to realize these benefits.
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
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
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
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.
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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
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