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SAN ANTONIO, Texas - Biodexa Pharmaceuticals PLC (NASDAQ: BDRX), a clinical-stage biopharmaceutical company with a market capitalization of $2.04 million, announced today a successful outcome from its Type C meeting with the U.S. Food and Drug Administration (FDA) regarding its Phase 3 study protocol for eRapa in familial adenomatous polyposis (FAP). According to InvestingPro data, the company maintains a healthy current ratio of 2.16, indicating strong short-term liquidity despite challenging market conditions. This paves the way for the finalization of the Phase 3 protocol and the recruitment of clinical sites in the U.S.
The FDA’s feedback, received after a productive End of Phase 2 discussion, supports the initiation of a registrational Phase 3 trial for eRapa, which is expected to commence next quarter. The study will be a double-blind placebo-controlled trial involving 168 patients, randomized in a 2:1 ratio of drug to placebo. Approximately 30 clinical sites across the U.S. and Europe will participate, with the U.S. component managed by LumaBridge and the European component by Precision for Medicine LLC.
The Phase 3 trial is substantially funded by a $17.0 million grant from the Cancer Prevention Research Institute of Texas (CPRIT) and an $8.5 million company match, both of which have been fully paid into escrow. InvestingPro analysis reveals the company holds more cash than debt on its balance sheet, though it’s currently burning through cash rapidly - a crucial factor for investors monitoring the trial’s progression. Get access to 10+ additional ProTips and detailed financial metrics with InvestingPro.
Dr. Gary Shangold, Chief Medical Officer of Biodexa, remarked on the absence of approved products for FAP and the importance of collaborating with the FDA and LumaBridge to define the regulatory pathway for eRapa. The agreement on the composite endpoint is particularly crucial for advancing the study.
eRapa is an oral tablet formulation of rapamycin, designed to treat FAP by targeting the mTOR pathway involved in cellular metabolism, growth, and proliferation. Phase 2 data indicated that eRapa is safe and well-tolerated, showing a median 17% reduction in total polyp burden at 12 months and a 75% non-progression rate.
Biodexa’s pipeline also includes treatments for Non-Muscle Invasive Bladder Cancer, type 1 diabetes, and rare/orphan brain cancer indications. The company utilizes proprietary drug delivery technologies to improve the bioavailability and distribution of its medications.
This announcement is based on a press release statement and contains forward-looking statements subject to risks and uncertainties. It reflects management’s current expectations and does not constitute an update on the company’s public filings or announcements. With revenue of just $0.1 million in the last twelve months and an overall WEAK financial health score according to InvestingPro, investors should carefully consider the company’s development timeline and cash runway.
In other recent news, Biodexa Pharmaceuticals PLC has appointed Precision for Medicine, LLC as the clinical research organization for the European segment of its upcoming Phase 3 study of eRapa in Familial Adenomatous Polyposis (FAP). The trial is set to be a double-blind, placebo-controlled study involving 168 patients and will be conducted at approximately 30 clinical sites across the U.S. and Europe. This development highlights Biodexa’s continued efforts in advancing treatments for diseases with unmet medical needs. The U.S. portion of the trial will be managed by LumaBridge.
eRapa is an oral tablet formulation of rapamycin, designed to inhibit mTOR, a protein associated with cell growth and tumor development in FAP polyps. Precision for Medicine, with over two decades of experience in rare diseases, will bring its expertise to this project. Biodexa’s pipeline also includes other potential treatments, such as tolimidone for type 1 diabetes and MTX110 for rare brain cancers. The company is known for its drug delivery technologies aimed at improving the bio-delivery and bio-distribution of medicines. These recent developments are part of Biodexa’s ongoing efforts to enhance its therapeutic offerings.
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