Biodexa Announces Allowance of U.S. Patent Covering Tolimidone
2024年2月7日 - 10:30PM
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 including Type 1 diabetes (“T1D”) and
rare/orphan brain cancers, today announced that the U.S. Patent and
Trademark Office allowed U.S. patent application No. 16/546,595
titled “Prevention of Pancreatic Cell Degeneration” which was
exclusively licensed to Biodexa by Melior Pharmaceuticals, Inc.,
along with other patents, in a transaction which closed in December
2023.
Stephen Stamp, CEO and CFO of Biodexa, commented
“This soon-to-be-issued patent is expected to provide market
exclusivity for tolimidone in the U.S. and underpins our investment
thesis in ongoing preclinical studies and an upcoming Phase 2
program in Type 1 diabetes patients which we expect to start in
next quarter.”
About tolimidoneTolimidone is a
selective activator of the enzyme Lyn kinase which increases
phosphorylation of insulin substrate -1, thereby amplifying the
signalling cascade initiated by the binding of insulin to its
receptor.
Tolimidone’s potential utility in the treatment
of T1D has been demonstrated in several preclinical studies in
which Lyn kinase was identified as a key factor for beta cell
survival in in vitro and in vivo models.
As a first step in the continuing clinical
development of tolimidone, Biodexa plans to initiate an open-label
Phase 2a dose confirmation study in 2Q24 to establish the preferred
dose of tolimidone in patients with T1D. This will be followed by a
double-blind, placebo-controlled Phase 2b study. End points of both
studies will include C-peptide levels, HbA1c and the number of
hyperglycemic events.
Tolimidone was discovered by Pfizer Inc.
(“Pfizer”) which developed it through Phase 2 for the treatment of
gastric ulcers. Pfizer undertook a broad preclinical program to
characterize the pharmacology, pharmacokinetics, metabolism and
toxicology of tolimidone. Melior, together with Bukwang
Pharmaceutical Co Ltd, subsequently conducted two Phase 2 studies
in Type 2 diabetes. The two Phase 2 studies together with Pfizer’s
earlier work exposed more than 700 patients to tolimidone, creating
an extensive safety data package. For more information,
please contact:
Biodexa Pharmaceuticals PLC |
Stephen Stamp, CEO, CFO |
Tel: +44 (0)29 20480 180 |
www.biodexapharma.com |
Edison Group (US Investor Relations) |
Laine Yonker |
Tel: +1 (610) 716
2868 |
Email:
lyonker@edisongroup.com |
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 programmes
include tolimidone, under development as a novel agent for the
treatment of type 1 diabetes and MTX110, which is being studied in
aggressive rare/orphan brain cancer indications.
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 tumour, 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.” Examples of forward-looking statements include,
among others, statements we make regarding our pre-clinical
data and clinical trials. 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
the Company shall file from time to time or announcements that may
be made by the Company in accordance with the rules and regulations
promulgated by the United States Securities and Exchange
Commission, 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 the Company are expressly qualified in
their entirety by the cautionary statements above. Except as
may be required under relevant laws in the United States, the
Company does not undertake any obligation to publicly update or
revise any forward-looking statements because of new information,
future events or events otherwise arising.
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