RCS - Arecor Therapeutics - Arecor Presents Positive Data for AT278 at EASD

Arecor TherapeuticsAnnouncement

20/09/2022 11:15

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RNS Number : 9926Z  Arecor Therapeutics PLC  20 September 2022

Arecor Therapeutics plc

("Arecor", the "Company" or the "Group")

 

ARECOR PRESENTS DATA FROM POSITIVE PHASE I CLINICAL TRIAL OF

AT278 ULTRA-CONCENTRATED ULTRA-RAPID ACTING INSULIN FOR DIABETES AT EASD 2022

 

-      Delivers significantly accelerated absorption of insulin compared
to gold standard, NovoRapid(®)(100U/mL), even with a 5-fold increase in
concentration

-      Potential to significantly improve post prandial glucose control
and reduce number of daily injections for people with diabetes who have high
insulin needs

-      Critical enabler in development of next generation miniaturised
insulin-delivery systems

-      Favourable safety profile with no safety signals detected

 

Cambridge, UK, 20 September 2022. Arecor Therapeutics plc (AIM: AREC), the
biopharmaceutical company advancing today's therapies to enable healthier
lives, today presents positive results from the Phase I clinical trial of its
ultra-rapid acting, ultra-concentrated insulin product candidate, AT278, at
the European Association for the Study of Diabetes (EASD) Annual Meeting.

 

The abstract, "Phase I study investigating PK and PD of highly-concentrated
insulin aspart AT278 U500", is being presented as part of the Short Oral
Discussion Session A, "How complicated is type 1 diabetes?" (11:45-12:45
CEST).

 

AT278 is Arecor's ultra-concentrated (500 U/mL), ultra-rapid acting insulin
candidate, formulated using the Company's Arestat(TM) technology and designed
to significantly accelerate insulin absorption post injection to enable more
effective and convenient management of blood glucose levels in people with
high daily insulin requirements.

 

Dr Thomas Pieber, investigator for the ARE-278-102 study, Professor of
Medicine, Head of the Division of Endocrinology and Metabolism and Chairman of
the Department of Internal Medicine, Medical University of Graz, Austria,
said: "The rapid-acting characteristics of AT278, even with its 5-fold
increase in concentration, are clinically significant, suggesting that AT278
has the potential to significantly improve post prandial glucose control and
reduce the number of daily injections for people with diabetes who have high
insulin needs."

 

Sarah Howell, Chief Executive Officer of Arecor, added: "By enabling reduced
injection volumes and fewer injections per day, whilst offering the potential
for improved blood glucose control with its superior PK/PD profile, AT278 has
the potential to become the gold standard insulin treatment for the growing
population of people living with diabetes, who have high daily insulin needs,
particularly those with type 2 diabetes. A truly rapid acting concentrated
insulin such as AT278 is also critical to the development of next generation
miniaturised insulin delivery devices, where the size of such devices is often
a barrier to use by patients."

 

In the double-blind, randomised, single dose, two-period cross over Phase I
clinical study (EudraCT:2020-002033-15) the pharmacokinetic (PK) and
pharmacodynamic (PD) profile of AT278 was compared to NovoRapid®, the current
gold standard treatment, in 38 patients with type 1 diabetes. The trial was
conducted in a glucose clamp setting at the Medical University of Graz and
Joanneum Research in Austria, an internationally recognised centre of
excellence in the field of diabetes research.

 

The PK/PD profile for AT278 was accelerated compared with NovoRapid®.
Following dosing, AT278 showed a faster onset of insulin exposure compared
with NovoRapid(®), as demonstrated by an earlier onset of appearance (-6.0
min, P<0.0001), earlier t(Early50%Cmax) (-23.0 min, P<0.0001) and 4.0
times higher AUC(Insulin,0-30min) (95% CI: 3.29; 4.90). AT278 also showed a
more rapid onset of glucose-lowering effect compared with NovoRapid(®) as
demonstrated by an earlier onset of action (-9.5 min, P<0.0001) and earlier
t(Early50%GIRmax) (-20.0 min, P<0.0001). Overall insulin exposure and
glucose-lowering effect were comparable between both insulins
(AUC(Insulin,0-8h) treatment ratio 0.98 [95% CI: 0.92; 1.00]; AUC(GIR,0-8h)
treatment ratio 1.02 [95% CI: 0.95; 1.09]). All reported adverse events were
mild in intensity and no safety signals were detected.

 

A further clinical trial of AT278, in people living with type 2 diabetes, is
expected to be initiated later this year. The randomised, double-blind Phase I
study in obese type 2 diabetes patients will recruit approximately 28 adult
patients with each receiving one subcutaneous dose (0.5 U/kg) of AT278,
NovoRapid® and Humulin® R U 500 in three separate treatment periods. The
PK/PD profile will be measured in each treatment period in a glycemic clamp
setting.

 

The abstract, "Phase I study investigating PK and PD of highly-concentrated
insulin aspart AT278 U500" is available on the EASD 2022 website
(https://www.abstractsonline.com/pp8/#!/10613/presentation/1139) . These data
were first presented at the 15th International Advanced Technologies and
Treatments for Diabetes (ATTD) meeting in May 2022.

 

-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)   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

 

Notes to Editors

 

About Arecor

Arecor Therapeutics plc is a globally focused biopharmaceutical company
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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