REG - Arecor Therapeutics - FIRST PATIENT DOSED IN AT278 CLINICAL TRIAL

Arecor TherapeuticsAnnouncement

22/03/2023 07:15

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RNS Number : 7742T  Arecor Therapeutics PLC  22 March 2023

Arecor Therapeutics plc

("Arecor" or the "Group")

 

FIRST PATIENT DOSED IN SECOND PHASE I CLINICAL TRIAL OF AT278
ULTRA-CONCENTRATED, ULTRA-RAPID ACTING INSULIN CANDIDATE

 

-      Disrupter insulin with potential to be the first
ultra-concentrated and ultra-rapid acting insulin available for patients

-      AT278 aims to significantly improve post prandial glucose control
and reduce injection volume and potentially enable fewer injections per day
for people with Type 2 diabetes who have high insulin needs

-      Ultra-concentrated, ultra-rapid acting insulin such as AT278 is
critical to development of next generation miniaturised insulin delivery
devices

-      Trial expected to complete in Q4 2023

 

Cambridge, UK, 22 March 2023: Arecor Therapeutics plc (AIM: AREC), the
biopharmaceutical group advancing today's therapies to enable healthier lives,
today announces that the first patient has been dosed in its Phase I clinical
trial investigating AT278, an ultra-rapid acting, ultra-concentrated (500
U/mL) insulin candidate, in Type 2 diabetic patients, the primary target
population.

 

The trial is a double blind, randomised, crossover study comparing the
pharmacokinetic (PK) and pharmacodynamic (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,
which is expected to complete within Q4 2023, is being 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.

 

Sarah Howell, Chief Executive Officer at Arecor, said: "Having already
demonstrated AT278's very promising profile in Type 1 diabetes patients, we
look forward to furthering our understanding of its potential impact in Type 2
diabetes patients, the primary target market for this potential insulin
treatment.

 

"The number of people living with Type 2 diabetes is increasing year-on-year
and driven by the obesity epidemic, many are becoming insulin resistant,
requiring large volumes of insulin and multiple injections to manage their
condition, which is a heavy daily burden. With no concentrated (>200 U/mL)
rapid acting insulin products on the market, AT278 could be the first such
product available to patients, enabling effective blood glucose management
alongside the convenience and compliance benefits of high insulin doses in a
lower injection volume via a single injection. In addition, a truly rapid
acting, concentrated insulin is a critical step towards the advancement and
miniaturisation of the next generation of insulin delivery devices."

 

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. In the previous Phase I clinical study
(https://diabetesjournals.org/care/article/doi/10.2337/dc22-1054/148357/Pharmacokinetics-and-Pharmacodynamics-of-a-Novel)
in people with Type I diabetes, AT278 clearly demonstrated faster insulin
absorption with an accelerated PK/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 the UK
Market Abuse Regulation.

 

-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

 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 and Broker)
 Freddy Crossley, Emma Earl (Corporate Finance)  Tel: +44 (0) 20 7886 2500

 Rupert Dearden (Corporate Broking)

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

                                                 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™, 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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