CARDIFF, UK / ACCESSWIRE / November 21, 2024 / Biodexa Pharmaceuticals PLC (NASDAQ:BDRX), an acquisition-focused clinical-stage biopharmaceutical company focused on developing treatments for unmet medical needs, has made significant progress in transforming itself from a drug delivery innovator to a therapeutics company with a focus on drugs to fight diabetes and cancer.
Biodexa's strategy is not based on discovering new medicines; rather it looks to reduce the risk of failure in the clinic by re-purposing molecules with proven safety records for new indications. When Biodexa sees potential, it acquires these products from third parties under licensing agreements which generally call for the company to bear the costs of development and share the rewards of commercialization with the licensor.
eRapa soon to enter Phase 3
The shift to a therapeutics company is paying off for Biodexa as illustrated by its recent acquisition of eRapa for familial adenomatous polyposis, or FAP. FAP is an inherited condition that puts people at a much greater risk of developing colon cancer. With FAP, hundreds or thousands of precancerous polyps grow throughout the 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 adolescence - end up eventually having their entire colon removed and using a colostomy bag. If left untreated, there is a 100% chance the person will develop colorectal cancer.
"eRapa could be a transformational deal for Biodexa," says Biodexa CEO Stephen Stamp. "The deal included an upfront payment of only 5% of Biodexa in stock and zero development milestones."
As covered by Benzinga earlier this year, Biodexa published six-month phase 2 data, as well as 12-month data for eRapa that showed a median decrease in polyp burden of 29% and a non-progression rate of 89% in patients who received the preferred dosage regimen, reports Biodexa. "In a world where most drugs slow, or at best, halt progression, these results exceeded our expectations," said Stamp.
Phase 3 Through To NDA Largely Funded
The FAP program was awarded a $17 million grant from the Cancer Prevention Research Institute of Texas. The terms of the grant require a one to two match, and Biodexa said in September the final match payment was made, enabling Biodexa to access all of the remainder of the $25.5 million grant plus match. As a result, the company said the phase 3 study in FAP is largely funded through a New Drug Application (NDA) filing with the FDA, which it expects in three years' time. Biodexa said the next step is a "Type C" meeting with the FDA to finalize the Phase 3 protocol and start recruitment in early 2025.
"There are approximately 40,000 and 60,000 patients with FAP in the US and Europe respectively. As an orphan drug, eRapa will benefit from seven and 10 year exclusivity in the US and Europe, respectively, and based on the pricing of other orphan drugs, could achieve peak annual sales of $500 million to $1 billion," said Stamp.
It doesn't end there. Biodexa said there is currently an ongoing placebo-controlled phase 2 study of eRapa for non-muscle invasive bladder cancer (NMIBC), an early-stage bladder cancer. Biodexa said about 130 of 168 patients have been recruited so far, and it is evaluating the possibility of an interim analysis around the end of the year.
Furthermore, in October, the company announced the status of patients in Cohort A of the phase 1 study of its drug MTX110 - a solubilized formulation of the cancer drug panobinostat which is marketed as Farydak® - for recurrent glioblastoma, the most common and aggressive malignant primary brain cancer: all patients at that point had overall survival of between 12 and 13 months since starting treatment with MTX110, a significant improvement on overall survival of 2 to 9 months in the background population.
Tolimidone, a Phase 2-Ready Asset For Type 1 Diabetes
The company is currently working with the University of Alberta to initiate a Phase 2a dose confirmation study of tolimidone for the treatment of Type 1 diabetes. The study is designed to build on the preclinical data, which Biodexa said suggested tolimidone could have a proliferative impact on pancreatic beta cells, the cells responsible for insulin production.
Biodexa in-licensed tolimidone from Melior Discovery in December 2023 in return for 9.9% of Biodexa in stock with one modest development milestone, also payable in stock. Although as many as 8.5 million people worldwide suffer from Type 1 Diabetes, there are few therapeutic options outside the addition of exogenous insulin. If the preclinical data are borne out in human studies, tolimidone could halt disease progression, or maybe even reverse it, and offer hope to Type 1 sufferers,
"Over the next few months, we can expect the outcome of the Type C meeting with FDA on eRapa phase 3 program, the start of recruitment of the registrational Phase 3 study of eRapa in FAP, the start of recruitment of a Phase 2a study of tolimidone in Type 1 diabetes and interim analysis of eRapa phase 2 study in NMIBC," said Stamp. "Another busy and productive period for our team here at Biodexa."
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SOURCE: Biodexa Pharmaceuticals
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