TIDMAREC
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(R) (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.
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(R), 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(R) 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.
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
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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