Arecor Therapeutics PLC ARECOR TO COMMENCE SECOND TRIAL WITH AT278 (1352H)
November 22 2022 - 2:00AM
UK Regulatory
TIDMAREC
RNS Number : 1352H
Arecor Therapeutics PLC
22 November 2022
Arecor Therapeutics plc
("Arecor" or the "Group")
ARECOR TO COMMENCE SECOND CLINICAL TRIAL WITH AT278
ULTRA-Concentrated ULTRA-RAPID ACTIng INSULIN CANDIDATE FOR TYPE 2
DIABETES
Clinical Trial Application approved
EU Phase I clinical trial expected to commence in December
2022
Cambridge, UK, 22 November 2022: Arecor Therapeutics plc (AIM:
AREC), the biopharmaceutical group advancing today's therapies to
enable healthier lives, today announces the BASG ( Bundesamt für
Sicherheit im Gesundheitswesen) clearance of the Group's Clinical
Trial Application (CTA) for AT278, an ultra-rapid acting,
ultra-concentrated (500 U/mL) insulin candidate, in Type 2 diabetic
patients, the primary target population.
The approval of the CTA means that Arecor may now initiate the
second Phase I clinical trial for AT278, to further explore the
potential for AT278 to disrupt the market for insulin treatment, as
the first concentrated, yet rapid acting insulin. AT278 has
previously demonstrated a faster insulin absorption with an
accelerated Pharmacokinetic (PK) and Pharmacodynamic (PD) profile
compared to the lower concentration NovoRapid(R) (100 U/mL) in a
Phase I clinical study in Type 1 diabetic patients . This type 2
diabetes trial will also focus on exploring the PK/PD profile of
AT278 compared with NovoRapid(R) (100 U/mL), as well as Humulin-R
U500(R).
The trial is a double blind, randomised, crossover study
comparing the PK/PD profile following a single subcutaneous dose of
0.5 U/Kg of AT278 (500 U/mL) with NovoRapid(R) (100 U/mL) in 32
people with Type 2 diabetes in a euglycemic clamp setting. In
addition, the PK/PD profile following a single subcutaneous dose of
0.5 U/Kg Humulin-R U500(R) will be evaluated in each of the
participants. The trial will be conducted at the Medical University
of Graz, Austria, an expert clinical research facility in metabolic
diseases research and euglycaemic clamp methodology, with Professor
Thomas Pieber as the trial's Principal Investigator. This trial is
expected to initiate within 2022 and complete within Q4 2023.
Sarah Howell, Chief Executive Officer of Arecor, said: "With
regulatory approval to commence our second clinical trial for
AT278, we can continue the rapid progress we are making across our
proprietary diabetes focused portfolio. With its very promising
profile already demonstrated in our previous study, AT278 has the
potential to disrupt the market for insulin treatment as the first
concentrated, yet very rapid acting insulin and to become the gold
standard insulin for the growing population of people with diabetes
with high daily insulin needs as well a critical enabler in the
development of next generation miniaturised insulin delivery
systems. With approximately 537 million people living with diabetes
worldwide, of which approximately 56 million are insulin users,
there has never been a greater need for improved treatment
options."
AT278 is an ultra-concentrated (500 U/mL) novel formulation of
insulin that has been designed to accelerate the absorption of
insulin post injection, even when delivered at a high
concentration, and hence via a lower injection volume. Currently,
there are no concentrated (>200 U/mL) rapid acting insulin
products on the market, and therefore, AT278 has the potential to
be the first such product available to patients. It has the
potential to enable more effective management of blood glucose
levels to the increasing number of people with diabetes with high
daily insulin requirements (>200 units/day) whilst maintaining
the convenience and compliance benefits of being able to deliver
these high insulin doses in a lower injection volume via a single
injection. In addition, a truly rapid acting concentrated insulin
is also a critical step towards the advancement and miniaturisation
of the next generation of insulin delivery devices.
In the previous Phase I clinical study in people with Type I
diabetes, AT278 (500U/mL) clearly demonstrated faster insulin
absorption with an accelerated pharmacokinetic (PK) and
pharmacodynamic (PD) profile compared to gold-standard insulin
NovoRapid(R) (100U/mL) despite a 5-fold increase in
concentration.
This announcement contains inside information for the purposes
of Article 7 of Regulation (EU) 596/2014 (MAR)
-ENDS-
For more information, please contact:
Arecor Therapeutics plc www.arecor.com
Dr Sarah Howell, Chief Executive Tel: +44 (0) 1223 426060
Officer Email: info@arecor.com
Susan Lowther, Chief Financial Officer Tel: +44 (0) 1223 426060
Email: info@arecor.com
Mo Noonan, Communications Tel: +44 (0) 7876 444977
Email: mo.noonan@arecor.com
Panmure Gordon (UK) Limited (NOMAD Tel: +44 (0) 20 7886 2500
and Broker)
Freddy Crossley, Emma Earl (Corporate
Finance)
Rupert Dearden (Corporate Broking)
Consilium Strategic Communications
Chris Gardner, David Daley, Angela Tel: +44 (0) 20 3709 5700
Gray Email: arecor@consilium-comms.com
Notes to Editors
About Arecor
Arecor Therapeutics plc is a globally focused biopharmaceutical
group transforming patient care by bringing innovative medicines to
market through the enhancement of existing therapeutic products. By
applying our innovative proprietary formulation technology
platform, Arestat(TM), we are developing an internal portfolio of
proprietary products in diabetes and other indications, as well as
working with leading pharmaceutical and biotechnology companies to
deliver enhanced formulations of their therapeutic products. The
Arestat(TM) platform is supported by an extensive patent
portfolio.
For further details please see our website, www.arecor.com
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