27 November 2023
Biodexa Pharmaceuticals
PLC(“Biodexa” or the “Company”)
Biodexa Enters Into Agreements to Acquire
Exclusive Worldwide License to Tolimidone, a Phase II Ready Asset
for Type 1 Diabetes
Highlights:
- Acquisition of exclusive worldwide license to develop and
commercialize tolimidone
- Phase II ready with encouraging signals of β cell proliferation
in preclinical models
- Extensive safety database as Tolimidone exposed to
approximately [700] patients in other indications
Biodexa Pharmaceuticals PLC, (Nasdaq: BDRX), a
clinical stage biopharmaceutical company developing a pipeline of
innovative products for the treatment of diseases with unmet
medical needs, is pleased to announce that it has entered into an
agreement for the assignment of Adhera Therapeutics,
Inc.’s (“Adhera’s”) rights to tolimidone (formerly coded
MLR-1023) under an exclusive, worldwide, sub-licensable license
from Melior Pharmaceuticals I, Inc. (“Melior”) to develop,
manufacture, commercialize or otherwise exploit tolimidone.
About tolimidoneTolimidone was
originally discovered by Pfizer Inc. (“Pfizer”) and was developed
through Phase II for the treatment of gastric ulcers. Pfizer
undertook a broad pre-clinical program to characterize the
pharmacology, pharmacokinetics, metabolism and toxicology of
tolimidone. Pfizer discontinued development of the drug due to lack
of efficacy for that indication in a Phase II clinical trial.
Tolimidone 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.
Commenting, Stephen Stamp, CEO and CFO
of Biodexa, said: “Tolimidone offers the exciting
potential to radically improve disease management for millions of
Type-1 diabetes patients. We are eager to initiate a Phase II
clinical programme as expeditiously as possible to deliver a
positive impact on those patient’s lives. For Biodexa, we believe
this deal will significantly strengthen and diversify our pipeline
offering existing and new investors greater opportunities for value
creation.”
Tolimidone in T1DBiodexa plans
to develop tolimidone for the treatment of Type-1 diabetes
(T1D).
Tolimidone’s potential utility in T1D has been
demonstrated by several ground-breaking studies conducted by
Professor Jean Buteau at the University of Alberta, where lyn
kinase was identified as a key factor for beta cell survival and
proliferation in in vitro and in vivo models. Most importantly,
tolimidone was able to induce proliferation in beta cells isolated
from human cadavers. From a mechanism of action perspective,
tolimidone has been shown to both prevent beta cell degradation and
to stimulate beta cell proliferation.
As a first step in the planned continued
clinical development of tolimidone, the Company intends to conduct
a Phase Ib dose confirmation study in conjunction with the Alberta
Diabetes Institute at the University of Alberta to establish the
minimum effective dose of tolimidone in patients with T1D. The
Phase II study is expected to be a double-blind, placebo-controlled
study of approximately 35 patients with T1D over a period of four
months with C-peptide levels as primary end-point. C-peptide is
known to correlate with insulin levels in the body.
Type 1 and Type 2
Diabetes T1D and Type 2 diabetes (“T2D”) both occur
when the body cannot produce sufficient levels of insulin, the
hormone essential for regulating glucose levels in the blood.
Insufficient levels of insulin results in high blood sugar levels
leading to potentially serious complications. T1D
usually appears first in children and adolescents, but it can also
occur in adults. In T1D, the body’s immune system attacks
pancreatic beta cells so that they can no longer produce insulin.
The causes of T1D are not fully understood and there is currently
no cure. Patients with T1D are dependent on daily administration of
insulin (via injection or infusion). In a meta analysis of 1,202
articles and 193 studies, the incidence of T1D was shown to be 15
per 100,000 with a prevalence of 9.5 per 10,000 of the population1.
Tolimidone in T2DMelior initially evaluated tolimidone
for the treatment of T2D. In studies conducted in in
vivo models of T2D diabetes, tolimidone decreased blood
glucose levels in mouse and rat oral glucose tolerance tests, in
db/db mice and Zucker rats. Blood glucose lowering was produced
with both acute and chronic dosing regimens.
Melior, in partnership with Bukwang
Pharmaceutical Co. Ltd. (“Bukwang”), conducted two Phase II studies
in T2D. In the first Phase II study, 130 patients were treated with
four active doses; 100mg once daily, 100mg twice daily, 200mg one
daily and 200mg twice daily for four weeks. The primary endpoint
was a mixed meal tolerance test, or MMTT, conducted on day one and
day 29 and fasting plasma glucose, or FPG, was monitored weekly.
Top line results from analyses of covariance, or ANCOVA, showed
statistically significant (p=0.0079) improvement in MMTT and FPG in
the 100mg once daily dosed group. In addition, there was a
statistically significant decrease in MMTT in the 100mg twice daily
dosed group. In general, favorable drug effects in all dose groups
were suggestive of decreases in MMTT and FPG even when not
statistically significant. Beneficial changes were also observed in
all lipid parameters, though only triglycerides exhibited
statistically significant differences.
About the Proposed
Transaction
In connection with the assignment, the Company
agreed to pay up an upfront payment to Adhera and certain secured
noteholders of Adhera, in the form of cash, with respect to Adhera,
and the Company’s American Depositry Shares, with respect to the
secured noteholders, and such parties are eligible to receive
additional payments, in the form of cash and/or American Depositary
Shares, upon the achievement of certain milestones. In addition, in
connection with the license, the Company has agreed to issue to
Melior and Bukwang American Depositary Shares. The Company would
also be obligated to pay single digit tiered royalties on net sales
of tolimidone.
The assignment of rights by Adhera, and the
related effectiveness of the license, are each subject to certain
closing conditions. The transaction is expected to close in the
fourth quarter of 2023.
- National Library of Medicine, Mobasseri et al., published
online 2020 Mar 30. doi: 10.34172/hpp.2020.18
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) |
Alyssa
Factor |
Tel: +1 (860) 573
9637 |
Email:
afactor@edisongroup.com |
About Biodexa Pharmaceuticals PLC
Biodexa Pharmaceuticals PLC (listed on NASDAQ: BDRX) is a
clinical stage biopharmaceutical company developing a pipeline of
products aimed at primary and metastatic cancers of the
brain. The Company’s lead candidate, MTX110, is being studied
in aggressive rare/orphan brain cancer indications including
recurrent glioblastoma and diffuse midline glioma.
MTX110 is a liquid formulation of the histone deacetylase (HDAC)
inhibitor, panobinostat. This proprietary formulation enables
delivery of the product via convection-enhanced delivery (CED) at
potentially therapeutic doses directly to the site of the tumour,
by-passing the blood-brain barrier and 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 the assignment of rights
to tolimidone and related license from Melior and the Company’s
ability to close the transaction, potential uses by the Company of
tolimidone, information related to clinical trials, and
potential benefits of tolimidone.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.
Biodexa Pharmaceuticals PLC
Stephen Stamp, CEO, CFO
Tel: +44 (0)29 20480 180
www.biodexapharma.com
Edison Group (US Investor Relations)
Alyssa Factor
Tel: +1 (860) 573 9637
Email: afactor@edisongroup.com
Biodexa Pharmaceuticals (NASDAQ:BDRX)
過去 株価チャート
から 4 2024 まで 5 2024
Biodexa Pharmaceuticals (NASDAQ:BDRX)
過去 株価チャート
から 5 2023 まで 5 2024