Announces Payment of $3.0MM Final Match Payment Enabling Access to Remainder of $17.0MM CPRIT Grant
Rhea-AI Summary
Biodexa Pharmaceuticals PLC (Nasdaq: BDRX) has made the final match payment for a $17 million grant from the Cancer Prevention Research Institute of Texas (CPRIT). This payment enables access to the remaining grant funds, which will be used to finance the upcoming Phase 3 registrational study of eRapa for Familial Adenomatous Polyposis (FAP). FAP is an inherited disease causing precancerous polyps in the GI tract, affecting approximately 100,000 patients in the U.S. and Europe. A previous 12-month Phase 2 trial of eRapa showed promising results, with a 17% median decrease in overall polyp burden and a 75% non-progression rate. The Phase 3 trial is expected to begin enrollment in early 2025.
Positive
- Secured access to remainder of $17 million CPRIT grant
- Funding secured for Phase 3 registrational study of eRapa
- Positive Phase 2 results: 17% median decrease in polyp burden
- 75% non-progression rate in Phase 2 trial
- Targeting an orphan indication with 100,000 patients in U.S. and Europe
- No approved therapeutic options for FAP, indicating potential market opportunity
Negative
- Required to make match payments to access grant funds
- Phase 3 trial enrollment not starting until early 2025
News Market Reaction 1 Alert
On the day this news was published, BDRX declined 2.89%, reflecting a moderate negative market reaction.
Data tracked by StockTitan Argus on the day of publication.
September 16, 2024
Biodexa Pharmaceuticals PLC
Announces Payment of
Funds to Advance Development of Phase 3 Asset
Biodexa Pharmaceuticals PLC (“Biodexa” or the “Company”) (Nasdaq: BDRX), an acquisition-focused clinical stage biopharmaceutical company developing a pipeline of innovative products for the treatment of diseases with unmet medical needs, today announces it made the final match payment with respect to a
Commenting, Stephen Stamp, CEO and CFO of Biodexa said “Having made the second and final match payment, we now have access to the remainder of the
Familial Adenomatous Polyposis (FAP) is an inherited disease that causes the growth of hundreds or thousands of precancerous polyps throughout the GI tract, putting those afflicted at great risk of developing colon cancer. There is no approved therapeutic option for treating the approximately 100,000 FAP patients in the U.S. and Europe. The current standard of care is active surveillance and surgical resection of the colon and/or rectum.
Results of a 12cmonth Phase 2 clinical trial of eRapa in FAP demonstrated a 17 per cent median decrease in overall polyp burden and an overall non-progression rate of 75 per cent. A Phase 3 registrational trial is expected to begin enrollment early next year.
About the Cancer Prevention and Research Institute of Texas
CPRIT was created by the Texas Legislature and approved by a statewide vote in 2007 to lead the Lone Star State’s fight against cancer. In 2019, Texas voters again voted overwhelmingly to continue CPRIT with an additional
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 signaling pathway that regulates cellular metabolism, growth and proliferation and is activated during tumorgenesis.
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 glycemic 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 solubilised 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 including, but not limited to, the anticipated net proceeds, and the anticipated use of proceeds therefrom, and projected cash runway. 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.
For more information, please contact:
| Biodexa Pharmaceuticals PLC |
| Stephen Stamp, CEO, CFO Tel: +44 (0)29 20480 180 www.biodexapharma.com |
FAQ
What is the total amount of the CPRIT grant received by Biodexa Pharmaceuticals (BDRX)?
What is the purpose of the CPRIT grant for Biodexa Pharmaceuticals (BDRX)?
When is Biodexa Pharmaceuticals (BDRX) expected to begin enrollment for the Phase 3 trial of eRapa?
What were the key results from the Phase 2 clinical trial of eRapa conducted by Biodexa Pharmaceuticals (BDRX)?
