Shares of Biodexa Pharmaceuticals Plc (NASDAQ: BDRX) experienced a significant rise after the company provided an update on its clinical trial progress. In the latest pre-market session, BDRX stock surged 19.60%, reaching $2.41 per share. The company’s progress in getting ready for a Phase 3 study of eRapa, its patented encapsulated rapamycin formulation for treating familial adenomatous polyposis (FAP), has led to this notable rise.
Developments in the Preparation of Phase 3 Trials
Recent significant accomplishments for Biodexa include obtaining FDA Fast Track designation, completing its Phase 3 trial protocol with a successful Type C meeting, and selecting clinical research organizations (CROs) for the U.S. and European study components. These advancements represent important steps in the direction of starting a registrational study.
Resolving Unmet Health Needs
FAP is a genetic condition that causes many precancerous polyps to form, which dramatically raises the risk of colorectal cancer. There are currently no authorized pharmaceutical therapies; the mainstay of therapy is still surgery and observation. Biodexa’s eRapa, an oral formulation of rapamycin (sirolimus), inhibits the mammalian Target of Rapamycin (mTOR) protein, which has been linked to FAP polyp growth, making it a promising therapeutic candidate.
Encouraging Clinical Data and Study Design
Biodexa’s Phase 2 trial of eRapa demonstrated promising results, showing a 17% median reduction in polyp burden and a 75% non-progression rate. Additionally, after a 12-month period, individuals on the Phase 3 dose regimen saw a 29% median decrease in polyp burden and an 89% non-progression rate. 168 high-risk FAP patients from 30 locations in the US and Europe will participate in the next Phase 3 trial, which will be double-blind and placebo-controlled.
Strong Financial Backing for the Trial
The Phase 3 trial is backed by a $17 million grant from the Cancer Prevention Research Institute of Texas, with Biodexa contributing $8.5 million, bringing total funding to $25.5 million. With a well-defined regulatory path following the recent FDA meeting, Biodexa anticipates initiating the U.S. segment of the trial next quarter.