Biodexa Pharmaceuticals has enrolled the initial two subjects in the placebo-controlled Phase III Serenta study of an oral capsule formulation of rapamycin, eRapa, involving individuals with familial adenomatous polyposis (FAP).
FAP is said to be an inherited condition that often progresses to colorectal cancer without intervention.
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The subjects have been enrolled by the Pan American Center for Oncology Trials in Puerto Rico.
According to the company, individuals with FAP have limited treatment options currently, which primarily involve sequential resection of the gastrointestinal tract.
The double-blind trial aims to test the efficacy and safety of eRapa. It will include 168 subjects, with a 2:1 ratio of drug to placebo randomisation.
The trial is set to be conducted across multiple sites, with the US portion being managed by LumaBridge in Texas, encompassing 20 locations.
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By GlobalDataAdditionally, Precision for Medicine will oversee the European segment, which includes ten sites. All sites have been recognised and are in the process of preparing for the study.
Biodexa Pharmaceuticals CFO and CEO Stephen Stamp stated: “Enrolling the first patients in our pivotal Phase III study in FAP is a seminal event for our company, our collaborator Emtora Biosciences, and our CRO, LumaBridge.
“As the only drug candidate for FAP in Phase III, our combined team is committed to advancing eRapa as the first non-surgical treatment for the thousands of patients worldwide suffering from this debilitating disease.”
Rapamycin, also referred to as sirolimus, is a mammalian Target Of Rapamycin (mTOR) inhibitor.
Overexpression of mTOR has been observed in the polyps associated with FAP, providing a scientific basis for using eRapa as a targeted treatment.
Currently, rapamycin has received approval in the US for organ rejection in renal transplants under the brand name Rapamune by Pfizer.
eRapa leverages nanotechnology and pH-sensitive polymers to improve upon the issues of bioavailability, pharmacokinetics, and toxicity that are common with existing rapamycin treatments.
The drug is supported by several issued patents, ensuring protection until at least 2035, with additional pending applications that could extend this period.
