Biodexa Announces Allowance of U.S. Patent Covering Oral Rapamycin Nanoparticle Preparations (“eRapa”) and Use

Rhea-AI Summary

Biodexa Pharmaceuticals (Nasdaq: BDRX) has received allowance for U.S. patent application No. 17/391.495, titled 'Oral Rapamycin Nanoparticle Preparations and Use' for its eRapa technology. The patent, exclusively licensed from Rapamycin Holdings (d/b/a Emtora Biosciences) in April 2024, will issue on March 4, 2025, and is expected to expire in March 2034.

The company plans to initiate a Phase 3 registrational study of eRapa in Familial Adenomatous Polyposis (FAP) next quarter. The FDA has already granted orphan drug designation for eRapa in FAP, providing seven years of market exclusivity upon approval in the US. This new patent adds an additional layer of protection for the novel drug formulation as Biodexa explores additional indications.

Positive

• Patent protection secured until March 2034 for eRapa technology
• FDA orphan drug designation provides 7 years market exclusivity
• Phase 3 trial for FAP indication starting next quarter

Negative

• None.

Insights

Pharmaceutical Patent & Clinical Development Expert

The USPTO's allowance of Biodexa's patent application for eRapa represents a important milestone that significantly strengthens the company's market position. The patent, extending to 2034, combined with the seven-year orphan drug exclusivity, creates a formidable dual layer of market protection that could potentially extend beyond 2041 for the FAP indication.

The nanoparticle formulation technology covered by this patent is particularly significant as it typically enables enhanced bioavailability and more precise drug delivery compared to conventional formulations. This technological advantage could translate into improved efficacy and potentially better patient compliance, critical factors for success in rare disease markets like FAP.

The timing of the Phase 3 study initiation next quarter is strategically important, as it positions Biodexa to potentially capture first-mover advantage in the FAP market. The company's strategy of investigating additional indications beyond FAP is particularly noteworthy, as it could unlock multiple revenue streams from a single patented formulation - a common strategy employed by successful rare disease companies to maximize return on investment.

The patent's scope covering both the preparation method and use provides broad protection against potential competitors, while the exclusive licensing agreement with Rapamycin Holdings suggests a well-structured intellectual property strategy. This comprehensive IP protection could make Biodexa an attractive partner for larger pharmaceutical companies looking to expand their rare disease portfolios.

February 24, 2025

Biodexa Announces Allowance of U.S. Patent Covering
Oral Rapamycin Nanoparticle Preparations (“eRapa”) and Use

Biodexa plans to initiate a Phase 3 registrational study of eRapa in
Familial Adenomatous Polyposis (FAP) next quarter

Biodexa Pharmaceuticals PLC (“Biodexa” or the “Company”)(Nasdaq: BDRX), a clinical stage biopharmaceutical company developing a pipeline of innovative products for the treatment of diseases with unmet medical needs, today announced that the U.S. Patent and Trademark Office allowed has U.S. patent application No. 17/391.495 titled “Oral Rapamycin Nanoparticle Preparations and Use” which was exclusively licensed to Biodexa by Rapamycin Holdings, Inc. d/b/a Emtora Biosciences, along with other patents, in a transaction which closed in April 2024. The patent is due to issue on March 4, 2025 and, in the absence of any patent term extensions, is expected to expire in March, 2034.

Stephen Stamp, CEO and CFO of Biodexa, commented “The FDA has already granted orphan drug designation for our most advanced program, eRapa in FAP which confers seven years market exclusivity from approval in the US. This patent provides a welcome additional layer of exclusivity for the novel eRapa drug formulation as we investigate additional indications.”

About eRapa

eRapa is a proprietary oral tablet formulation of rapamycin, also known as sirolimus. Rapamycin is an mTOR (mammalian Target Of Rapamycin) inhibitor. mTOR has been shown to have a significant role in the signalling pathway that regulates cellular metabolism, growth and proliferation and is activated during tumorgenesis³. Importantly, mTOR has been shown to be over-expressed in FAP polyps – thereby underscoring the rationale for using a potent and safe mTOR inhibitor like eRapa to treat FAP. Rapamycin is approved in the US for organ rejection in renal transplantation as Rapamune®(Pfizer). Through the use of nanotechnology and pH sensitive polymers, eRapa is designed to address the poor bioavailability, variable pharmacokinetics and toxicity generally associated with the currently available forms of rapamycin. Compelling six month data from a Phase 2 study of eRapa in FAP were presented at Digestive Disease Week in April 2024 and 12 month data were presented at InSIGHT, Barcelona in June 2024. A registrational Phase 3 study in approximately 30 centers in the US and Europe is expected to begin recruitment next quarter. The Phase 3 program is substantially funded by a $17.0 million grant from the Cancer Prevention Research Institute of Texas (CPRIT) which has been matched by Company contributions of $8.5 million.
The Cancer Prevention and Research Institute of Texas
To date, CPRIT has awarded $2.9 billion in grants to Texas research institutions and organizations through its academic research, prevention and product development research programs. CPRIT has recruited 237 distinguished researchers, supported the establishment, expansion or relocation of 43 companies to Texas and generated over $5.7 billion in additional public and private investment. CPRIT funding has advanced scientific and clinical knowledge and provided 7.4 million life-saving cancer prevention and early detection services reaching Texans from all 254 counties. On November 5, 2019, Texas voters overwhelmingly approved a constitutional amendment to provide an additional $3 billion to CPRIT for a total $6 billion investment in cancer research and prevention. Learn more at https://cprit.texas.gov/.

About Biodexa Pharmaceuticals PLC

Biodexa Pharmaceuticals PLC (listed on NASDAQ: BDRX) is a clinical stage biopharmaceutical company developing a pipeline of innovative products for the treatment of diseases with unmet medical needs. The Company’s lead development programs include eRapa, under development for Familial Adenomatous Polyposis and Non-Muscle Invasive Blader Cancer; tolimidone, under development for the treatment of type 1 diabetes; and MTX110, which is being studied in aggressive rare/orphan brain cancer indications.

eRapa is a proprietary oral tablet formulation of rapamycin, also known as sirolimus. Rapamycin is an mTOR (mammalian Target Of Rapamycin) inhibitor. mTOR has been shown to have a significant role in the signalling pathway that regulates cellular metabolism, growth and proliferation and is activated during tumorigenesis.

Tolimidone is an orally delivered, potent and selective inhibitor of Lyn kinase. Lyn is a member of the Src family of protein tyrosine kinases, which is mainly expressed in hematopoietic cells, in neural tissues, liver, and adipose tissue. Tolimidone demonstrates glycaemic control via insulin sensitization in animal models of diabetes and has the potential to become a first in class blood glucose modulating agent.

MTX110 is a solubilized formulation of the histone deacetylase (HDAC) inhibitor, panobinostat. This proprietary formulation enables delivery of the product via convection-enhanced delivery (CED) at chemotherapeutic doses directly to the site of the tumor, by-passing the blood-brain barrier and potentially avoiding systemic toxicity.

Biodexa is supported by three proprietary drug delivery technologies focused on improving the bio-delivery and bio-distribution of medicines. Biodexa’s headquarters and R&D facility is in Cardiff, UK. For more information visit www.biodexapharma.com.

Forward-Looking Statements
Certain statements in this announcement may constitute “forward-looking statements” within the meaning of legislation in the United Kingdom and/or United States. Such statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and are based on management’s belief or interpretation. All statements contained in this announcement that do not relate to matters of historical fact should be considered forward-looking statements. In certain cases, forward-looking statements can be identified by the use of words such as “plans”, “expects” or “does not anticipate”, or “believes”, or variations of such words and phrases or statements that certain actions, events or results “may”, “could”, “would”, “might” or “will be taken”, “occur” or “be achieved.” Forward-looking statements and information are subject to various known and unknown risks and uncertainties, many of which are beyond the ability of the Company to control or predict, that may cause their actual results, performance or achievements to be materially different from those expressed or implied thereby, and are developed based on assumptions about such risks, uncertainties and other factors set out herein.

Reference should be made to those documents that Biodexa shall file from time to time or announcements that may be made by Biodexa in accordance with the rules and regulations promulgated by the SEC, which contain and identify other important factors that could cause actual results to differ materially from those contained in any projections or forward-looking statements. These forward-looking statements speak only as of the date of this announcement. All subsequent written and oral forward-looking statements by or concerning Biodexa are expressly qualified in their entirety by the cautionary statements above. Except as may be required under relevant laws in the United States, Biodexa does not undertake any obligation to publicly update or revise any forward-looking statements because of new information, future events or events otherwise arising.

FAQ

When will Biodexa's (BDRX) eRapa patent expire?

The patent is expected to expire in March 2034, barring any patent term extensions.

When is Biodexa (BDRX) starting the Phase 3 trial for eRapa in FAP?

Biodexa plans to initiate the Phase 3 registrational study for eRapa in Familial Adenomatous Polyposis (FAP) in the next quarter.

What market exclusivity protection does eRapa have for BDRX?

eRapa has FDA orphan drug designation providing 7 years of market exclusivity upon approval, plus patent protection until March 2034.

When will Biodexa's (BDRX) new eRapa patent be issued?

The patent will be issued on March 4, 2025.