Arecor Therapeutics plc
("Arecor" or "the Company")
AT278 ULTRA-CONCENTRATED ULTRA-RAPID ACTING
INSULIN DEMONSTRATES SUPERIORITY IN PHASE I CLINICAL TRIAL IN
OVERWEIGHT AND OBESE PEOPLE WITH TYPE 2 DIABETES
·
AT278 demonstrates
significantly accelerated PK/PD profile compared to NovoRapid® and Humulin® R U-500 in
people with Type 2 Diabetes and high
BMI
·
Confirms previous trial
results in people with Type 1 diabetes, demonstrating AT278 can
maintain fast and superior onset of action and glucose lowering
profile irrespective of diabetes type and BMI
·
Enables delivery of a
highly concentrated, low volume injection, offering more effective
mealtime glucose control to meet growing unmet need in patients
requiring high daily doses of insulin
·
Creates potential to be
the first, and only, ultra-concentrated (500 U/mL) ultra-rapid
insulin product enabling miniaturisation of next-generation insulin
pumps
·
Company will host a CEO
and key opinion leader webinar to discuss the results on Tuesday 21
May at 14.30 BST
Cambridge,
UK, 20 May 2024. Arecor Therapeutics plc (AIM: AREC), the
biopharmaceutical group advancing today's therapies to enable
healthier lives, today announces that its ultra-concentrated,
ultra-rapid acting insulin candidate, AT278, met all primary and
secondary endpoints, and also demonstrated superiority to
NovoRapid® and Humulin® R U-500, in a Phase I clinical trial in
Type 2 diabetics with a high body mass index (BMI).
AT278 (500 U/mL) is an ultra-concentrated,
ultra-rapid acting, novel formulation of insulin that accelerates
the absorption of insulin post injection, even when delivered at a
high concentration, and hence a lower injection volume. With no
concentrated (>200 U/mL), rapid acting insulins on the market,
AT278 has potential to be the first, and only, insulin available to
the growing number of patients with high daily insulin
requirements.
Sarah Howell, Chief
Executive Officer of Arecor, said: "We are delighted with the clinical results
from this second Phase I study, demonstrating AT278's superiority
over NovoRapid® and Humulin® R U-500 in Type 2 diabetics with a
high BMI. They further add to the positive results from our
previous clinical study in Type 1 diabetic patients, where
superiority was also demonstrated. This is a significant step in
AT278's development and extends our confidence
in its clear potential to provide a superior insulin
treatment option that lowers burden and improves outcomes for
people living with diabetes who require high daily doses of
insulin. Such patients make up a large segment of the target
market. In addition, as the only concentrated, yet very rapid
acting, insulin in development, AT278 has the capability to disrupt
the market by enabling the next generation of truly miniaturised,
longer-wear insulin pumps, a key focus for patients, physicians and
the industry."
Many Type 2 diabetics with a high BMI are currently
not well controlled, and improved treatments options such as AT278
are needed to reduce patient burden through fewer injections per
day, reduced injection volumes and dosing flexibility around
mealtimes. This lowering of burden for patients improves treatment
adherence and, allied with AT278's superior efficacy, should
improve both blood glucose control and outcomes. In addition, a
truly ultra-rapid, ultra-concentrated insulin is a critical step
towards next-generation miniaturised and long-wearing insulin
pumps, which are predicted to transform future diabetes
management.
Professor Thomas
Pieber, Principal Investigator for the ARE-278-104 clinical trial,
said: "These results are
highly significant, AT278
has clearly demonstrated faster insulin absorption with an
accelerated Pharmacokinetic (PK) and Pharmacodynamic (PD) profile
compared to the lower concentration standard insulin aspart
(NovoRapid®). The PK/PD profile of AT278 (500 U/mL) was also
greatly accelerated compared to Humulin® R U-500 (500 U/mL). Together with its
superior profile in the earlier Phase I clinical study in Type 1
diabetic patients1 AT278 has demonstrated its ability to
maintain a fast and superior onset of action and glucose lowering
profile irrespective of diabetes type and BMI. This makes AT278
completely unique in the competitive field of insulin analogues.
Not only does it have the potential to significantly improve
post-prandial glucose control whilst lowering burden for anybody
with diabetes who has a high daily insulin need, it can act as a
catalyst in the development of miniaturised insulin delivery
systems, where the size of
existing devices is a significant barrier to use for many
patients."
In the double-blind, randomised, two-way crossover
study, the pharmacokinetic (PK)/pharmacodynamic (PD) and safety
profiles of a single subcutaneous (SC) dose of 0.5 U/kg AT278 (500
U/mL) were compared with those of a single SC dose of 0.5 U/kg
NovoRapid® (100
U/mL), a currently available gold standard, rapid acting insulin
treatment, in 39 participants with Type 2 diabetes within a BMI
range of 25 and 39 kg/m2, in a euglycemic clamp setting.
The PK/PD profile of 0.5 U/kg AT278 (500 U/mL) was also compared to
a single SC dose of 0.5U/kg Humulin® R U-500 (500 U/mL) in an open label
manner.
· The trial met the primary endpoint
of non-inferiority with respect to glucose lowering actions
compared with NovoRapid®
· AT278 (500 U/mL) demonstrated a
significantly accelerated (superior) early PK/PD profile compared
to NovoRapid®
(100 U/mL), despite a 5-fold increase in concentration
· AT278 (500 U/mL) demonstrated a
significantly accelerated (superior) PK/PD profile compared to
Humulin® R U-500
(500 U/mL), the only other insulin available at a concentration of
500 U/mL
· No safety signals were detected
With around 537m people living with diabetes
worldwide, there are growing numbers of people who require insulin
to manage their blood glucose and, for many, their diabetes is
still poorly controlled. There is a growing need for highly
concentrated, much faster, and more physiological insulins to
effectively manage diabetes. In the US alone, nearly 10% of insulin
scripts written in 2022 were for products with a concentration of
>100 U/mL2. Furthermore, despite the improvements in
outcomes among people with diabetes who use insulin pumps and
automated delivery systems, they are still only used by less than
40% of people with Type 1 diabetes and less than 10% of people with
Type 2 diabetes in the US3. The size and short duration
of wear of existing insulin pumps remains a significant barrier to
use. AT278 has the potential to be the only highly concentrated,
ultra-rapid acting insulin to enable the next generation of
miniaturised, longer wear insulin pumps. The insulin pump market is
valued at circa $5.5bn market today4, with a
significant opportunity for substantial growth in this market by
expanding use across the Type 1 and Type 2 patient population that
can be further enabled by AT278 and a next generation insulin
pump.
A full analysis of the trial data is now underway to
enable the Company to determine and pursue a strategy for AT278
that maximises value for shareholders and patients. Detailed data
from the trial will be submitted for publication and presentation at a future international diabetes
conference.
AT278 clinical
results CEO and KOL webinar - Tuesday 21 May
Dr Sarah Howell, Chief Executive Officer, and
Professor Thomas Pieber, Principal Investigator for the ARE-278-104
clinical trial and Professor of Medicine, Head of the Division of
Endocrinology and Metabolism and Chairman of the Department of
Internal Medicine at Medical University of Graz, Austria will host
a CEO and key opinion leader webinar to discuss the clinical
results on Tuesday 21 May at 14.30 BST.
To register to join the live webcast click
here and to register for the conference line to ask questions
click here.
Please contact ICR Consilium for details on
arecor@consilium-comms.com.
This announcement contains inside
information for the purposes of the retained UK version of the EU
Market Abuse Regulation (EU) 596/2014 ("UK MAR").
-ENDS-
References
1.
Pharmacokinetics and Pharmacodynamics of a Novel
U500 Insulin Aspart Formulation: A Randomized, Double-Blind,
Crossover Study in People With Type 1 Diabetes Care
2023;46(4):757-764: https://doi.org/10.2337/dc22-1054
2. 2022
reports from Symphony. Retrieved October 2023
3. Seagrove
Partners Diabetes Bluebook 2022
4. Insulin
pump company annual reports and Company estimates
For more information,
please contact:
Arecor Therapeutics
plc
|
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
|
|
|
Panmure Gordon (UK)
Limited (NOMAD and Broker)
|
|
Freddy Crossley, Emma Earl (Corporate Finance)
Rupert Dearden (Corporate Broking)
|
Tel: +44 (0) 20 7886 2500
|
|
|
WG Partners
LLP (Financial Advisor)
|
|
Nigel Barnes, Satheesh Nadarajah
David Wilson, Claes Spang
|
Tel: +44 (0)203 705 9321
|
|
|
ICR
Consilium
|
|
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 company transforming patient care by bringing
innovative medicines to market through the enhancement of existing
therapeutic products. By applying our innovative proprietary
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 therapeutic products. The
Arestat™ platform is supported by an extensive patent
portfolio.
For further details please see our website, www.arecor.com