REG - Arecor Therapeutics - ARECOR TO COMMENCE SECOND TRIAL WITH AT278

Arecor TherapeuticsAnnouncement

22/11/2022 07:00

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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® (100 U/mL) in a Phase
I clinical study in Type 1 diabetic patients
(https://arecor.com/wp-content/uploads/2022/09/2022-09-20-ARECOR-PRESENTS-DATA-FROM-POSITIVE-PHASE-I-CLINICAL-TRIAL-OF-AT278-AT-EASD.pdf)
.  This type 2 diabetes trial will also focus on exploring the PK/PD profile
of AT278 compared with NovoRapid® (100 U/mL), as well as Humulin-R U500®.

 

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® (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® 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® (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 (http://www.arecor.com/)
 Dr Sarah Howell, Chief Executive Officer         Tel: +44 (0) 1223 426060

                                                  Email: info@arecor.com (mailto:sarah.howell@arecor.com)

 Susan Lowther, Chief Financial Officer           Tel: +44 (0) 1223 426060

                                                  Email: info@arecor.com (mailto:susan.lowther@arecor.com)

 Mo Noonan, Communications                        Tel: +44 (0) 7876 444977

                                                  Email: mo.noonan@arecor.com (mailto:mo.noonan@arecor.com)

 Panmure Gordon (UK) Limited (NOMAD and Broker)   Tel: +44 (0) 20 7886 2500

 Freddy Crossley, Emma Earl (Corporate Finance)

 Rupert Dearden (Corporate Broking)

 Consilium Strategic Communications
 Chris Gardner, David Daley, Angela Gray          Tel: +44 (0) 20 3709 5700

                                                  Email: arecor@consilium-comms.com (mailto: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™, 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™
platform is supported by an extensive patent portfolio.

 

For further details please see our website, www.arecor.com
(http://www.arecor.com)

 

 

 

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