TIDMAREC
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(R) (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: "B y
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(R), 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(R). Following dosing, AT278 showed a faster onset of
insulin exposure compared with NovoRapid(R) , 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 (R)
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(R)
and Humulin(R) 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. 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
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
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(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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