CARDIFF, UK - Biodexa Pharmaceuticals PLC (NASDAQ:BDRX), a biopharmaceutical company, has reported positive results from a Phase 2 clinical trial for eRapa, its investigational drug for Familial Adenomatous Polyposis (FAP). The study findings, presented at the InSIGHT biannual meeting, indicated a significant reduction in polyp burden among FAP patients.
FAP is a genetic disorder characterized by the growth of numerous precancerous polyps in the gastrointestinal tract, often leading to colorectal cancer if untreated. Currently, patients with FAP typically undergo regular screenings and surgeries, including the removal of the colon and/or rectum.
The 12-month Phase 2 trial data showed a median decrease in overall polyp burden of 17% and a non-progression rate of 75%. Notably, patients in Cohort 2, who received the drug daily every alternate week, saw an 89% non-progression rate and a 29% median reduction in polyp burden. These results suggest that eRapa could potentially reduce the need for surgical interventions and improve patients' quality of life.
eRapa, an oral tablet formulation of rapamycin, acts on the mTOR protein, which is associated with cancer development. The Phase 2 study was conducted across seven U.S. centers, enrolling 30 adults with FAP. The trial was partially funded by the Cancer Prevention and Research Institute of Texas (CPRIT), which has also granted $17 million for the upcoming phase 3 trial.
Biodexa's CEO, Stephen Stamp, expressed optimism about the Phase 2 outcomes, which, if replicated in the Phase 3 study, could offer a therapeutic alternative for FAP treatment. The Phase 3 trial is expected to be a double-blind placebo-controlled study involving approximately 140 high-risk FAP patients.
This development is particularly significant for the estimated 100,000 individuals worldwide afflicted with this condition. The Phase 3 trial's results could potentially provide a less invasive treatment option for FAP patients, marking a substantial advancement in the management of the disease.
The information in this article is based on a press release statement from Biodexa Pharmaceuticals PLC.
InvestingPro Insights
Biodexa Pharmaceuticals PLC (NASDAQ:BDRX) has recently drawn attention with its promising clinical trial results for eRapa, yet its financials paint a complex picture. According to InvestingPro data, BDRX holds a market capitalization of just $6.85 million USD, reflecting a niche player in the biopharmaceutical industry. Despite the potential breakthrough in treating Familial Adenomatous Polyposis (FAP), the company's revenue for the last twelve months as of Q4 2023 stood at a modest $0.49 million USD, with a significant decline of 45.49% compared to the previous period.
One of the standout InvestingPro Tips for BDRX is the fact that it holds more cash than debt on its balance sheet, which can be an indicator of financial stability and the ability to fund ongoing research and trials without the immediate need for additional financing. This could be particularly relevant for investors looking at the company's ability to sustain its operations through the upcoming phase 3 trial for eRapa.
On the other hand, the same InvestingPro Tips highlight that BDRX is quickly burning through cash and analysts do not anticipate the company will be profitable this year. This suggests that while the company may have adequate cash reserves now, its current spending rate could pose risks for future liquidity, especially if additional capital is not raised or if the company does not start generating more significant revenue.
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