REG - Arecor Therapeutics - ARECOR PRESENTS AT278 PHASE I DATA AT ATTD MEETING

Arecor TherapeuticsAnnouncement

28/04/2022 07:00

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RNS Number : 6032J  Arecor Therapeutics PLC  28 April 2022

ARECOR PRESENTS FULL DATA FROM POSITIVE PHASE I CLINICAL TRIAL OF

AT278 ULTRA-CONCENTRATED ULTRA-RAPID ACTING INSULIN FOR DIABETES AT ATTD
MEETING

 

-      Demonstrates best-in-class potential for effective disease
management in patients requiring high daily doses of insulin

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

-      A critical enabler in the development of next generation
miniaturised insulin-delivery systems

-      Favourable safety profile

 

Cambridge, UK, 28 April 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 15(th) International Advanced Technologies and Treatments for Diabetes
(ATTD) meeting.  The abstract is available on the ATTD website
(https://attd.kenes.com/scientific-program/) .

 

Dr Eva Svehlikova, Investigator for the ARE-278-102 study, said: "Currently,
there are no concentrated (>200U/mL) rapid acting insulin products on the
market.  AT278's faster insulin absorption with an accelerated
pharmacokinetic (PK) and pharmacodynamic (PD) profile when compared to
NovoRapid®, the current gold standard treatment, offers the potential to
significantly improve post prandial glucose control and reduce the number of
daily injections for people with diabetes that have high insulin needs. These
results are clinically significant and suggest that AT278 has the potential to
be the first ultra-concentrated, ultra-rapid insulin available to diabetic
patients."

 

Sarah Howell, Chief Executive Officer of Arecor, added: "Presenting the
positive data achieved in our successful AT278 Phase I clinical study at ATTD
marks another significant step forward for Arecor's best-in-class diabetes
franchise. 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. AT278 has
the potential to disrupt the market, as the first ultra-concentrated (500U/mL)
ultra-rapid acting insulin, reducing the burden of managing this complex
disease 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. This combination has the potential to liberate
patients with fewer injections, deliver better health outcomes and reduce the
healthcare burden across the growing diabetes market. AT278 also has the
potential to enable the development of next generation miniaturised insulin
delivery devices, where the size of such devices is often a barrier to use by
patients."

 

AT278 is an investigational meal-time, concentrated (500 U/mL) novel
formulation of insulin, that aims to significantly accelerate the absorption
of insulin post injection, to enable more effective management of blood
glucose levels. It has been designed to achieve PK/PD properties that are
superior to existing rapid acting insulins, despite a 5-fold increase in
concentration, thus enabling a lower volume and/or a reduced number of daily
injections and offering a significant advancement in treatment for people
living with diabetes who require high daily insulin doses to effectively
manage their blood glucose.

 

The double-blind, randomised, single dose, two-period cross over Phase I
clinical study (EudraCT:2020-002033-15) compared the PK/PD profiles of AT278
to NovoRapid® 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.

 

The next step on the accelerated development pathway for AT278 will be to
explore its potential to improve blood glucose control in people with type 2
diabetes with high daily insulin needs. With no highly concentrated (500 U/mL)
rapid acting insulin products currently available, AT278 has the potential to
be the first such product for this patient group to address a significant
unmet need and enable better blood glucose control at meal-times.

 

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

 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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