Biodexa Pharmaceuticals PLC BDRX announced progress on eRapa, its drug to treat Familial Adenomatous Polyposis (FAP), an inherited disorder characterized by cancer of the large intestine (colon) and rectum.
12-month data from a phase 2 clinical trial were recently presented at the 2024 InSIGHT biannual meeting.
With FAP, hundreds or thousands of precancerous polyps grow throughout the gastrointestinal tract. There is no approved therapeutic option for treating FAP patients.
Biodexa believes eRapa could be the first therapeutic option to treat this precancerous condition, and its data support that assessment.
Results of a 12-month phase 2 clinical trial of eRapa demonstrated an overall 17% median decrease in overall polyp burden and an overall non-progression rate of 75%.
For patients in Cohort 2 (treated daily, alternate weeks), 89% were deemed non-progressors at 12 months, with a median reduction in polyp burden of 29%.
eRapa is a proprietary oral tablet formulation of rapamycin, also known as sirolimus, which slows down the mTOR (mammalian Target Of Rapamycin) protein. Too much mTOR has been linked to cancer.
Biodexa said the dosing given to cohort 2 – daily every other week – will likely be the preferred dosage regime for its phase 3 trial, which the company is gearing up to launch soon.
That study is planned to be a double-blind placebo-controlled design recruiting approximately 140 high-risk patients diagnosed with germline or phenotypic FAP.
Price Action: BDRX shares are up 47.7% at $1.05 at last check Thursday.
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