REG - Arecor Therapeutics - Positive headline results for AT278 clinical trial

Arecor TherapeuticsAnnouncement

20/05/2024 07:00

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RNS Number : 0062P  Arecor Therapeutics PLC  20 May 2024

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 patients(1) 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/m(2), 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/mL(2).
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 US(3). 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 today(4), 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
(https://www.lsegissuerservices.com/spark/ARECORTHERAPEUTICS/events/a20a7e23-a0c4-438a-81b2-a0a92369a846)
and to register for the conference line to ask questions click here
(https://registrations.events/direct/LON6794572) .

 

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
(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 (http://www.arecor.com/)
 Dr Sarah Howell, Chief Executive Officer        Tel: +44 (0) 1223 426060

                                                 Email: info@arecor.com (mailto:info@arecor.com)

 Susan Lowther, Chief Financial Officer          Tel: +44 (0) 1223 426060

                                                 Email: info@arecor.com (mailto:info@arecor.com)

 Panmure Gordon (UK) Limited (NOMAD and Broker)
 Freddy Crossley, Emma Earl (Corporate Finance)  Tel: +44 (0) 20 7886 2500

 Rupert Dearden (Corporate Broking)

 WG Partners LLP (Financial Advisor)
 Nigel Barnes, Satheesh Nadarajah                Tel: +44 (0)203 705 9321

 David Wilson, Claes Spang

 ICR Consilium
 Chris Gardner, David Daley, Lindsey Neville     Tel: +44 (0) 20 3709 5700

                                                 Email: arecor@consilium-comms.com (mailto: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
(http://www.arecor.com)

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