Update
$Biodexa Pharmaceuticals (BDRX.US)$ 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.
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.
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