REG - Arecor Therapeutics - Positive FDA Feedback on Phase 2 Study Design

Arecor TherapeuticsAnnouncement

04/09/2025 07:00

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RNS Number : 8918X  Arecor Therapeutics PLC  04 September 2025

Arecor Therapeutics plc

("Arecor" or the "Company")

 

Positive FDA feedback on Phase 2 clinical study design for ultra-concentrated
and ultra-rapid acting insulin, AT278, in combination with an Automated
Insulin Delivery (AID) system

-      First-of-a-kind study of ultra-concentrated (500 U/mL) ultra-rapid
insulin in combination with an AID system

-      Primary efficacy endpoint will use Time-in-Range (TIR), enabling
much faster development than using standard HbA1c

-      Arecor on track to commence Phase 2 study in mid-2026, subject to
further funding

-      Strategy to partner with US insulin pump company to conduct the
Phase 2 study as a key step towards developing a unique next generation AID
system addressing unmet needs in diabetes treatment

 

Cambridge, UK, 4 September 2025: Arecor Therapeutics plc (AIM: AREC), the
biopharmaceutical company focused on drug development and delivery in diabetes
and other cardiometabolic diseases, announces that it has concluded a positive
Type C meeting with the US Food and Drug Administration (FDA) for AT278 in
people with both type 1 and type 2 diabetes with high daily insulin needs.

The purpose of the meeting was to discuss the design of a proposed Phase 2
clinical study for AT278 delivered by continuous infusion via an AID system,
ahead of a planned Investigational New Drug (IND) submission. Positive FDA
feedback and guidance on the clinical trial design is a major achievement for
Arecor and a significant step toward a successful Phase 2 study.

Key features of the study include using TIR as a primary efficacy endpoint
which will provide real-time information on glycaemic variability and
alongside continuous glucose monitoring (CGM)-derived metrics will provide
meaningful insights on drug effect to help optimize further development. This
primary end-point data can also be generated over a 6-week dosing period
compared with a minimum 12-week dosing period for HbA1c, enabling much faster
development. The design of the trial in combination with an AID system, will
also generate key data that will lay the foundations in demonstrating the
benefit to patients and the economic value of this new treatment option.

AT278 is Arecor's proprietary formulation of an ultra-concentrated (500 U/mL)
and ultra-rapid acting insulin and is the only insulin in development with the
potential to enable longer-wear for high daily insulin users in existing AID
systems as well as future insulin pump miniaturisation. With its best-in-class
profile, it has the potential to disrupt the market for insulin treatment in a
growing population of people with diabetes.

AT278 combines two fundamental properties, ultra-high concentration and an
ultra-rapid profile, which provide the potential to enable next generation AID
systems that address strong unmet needs in diabetes treatment.  This will be
the first time that such an insulin will be assessed in combination with an
AID system in a clinical study.

Arecor plans to submit the Phase 2 IND to the FDA during 2026 with the aim of
commencing enrolment for the Phase 2 study later in that year.  The proposed
study will be conducted in the US and is a Phase 2 six week cross-over study
comparing AT278 (500 U/mL) with NovoLog® (100 U/mL) expected to be in less
than 100 subjects with type 1 and type 2 diabetes. Continuous glucose
monitoring (CGM) derived percentage time-in-range (TIR) will be used as the
primary efficacy endpoint.

The study will build upon the positive Phase 1 data already generated on AT278
in both type 1 and type 2 diabetes where it demonstrated superiority to
existing insulin products, NovoRapid® (NovoLog® in the US) and Humulin® R
U-500.

Sarah Howell, CEO of Arecor said:

"Such positive and constructive feedback from the FDA for our first-of-a-kind
insulin and AID system combination study represents a significant milestone in
our drug development program. We believe we will generate crucial data towards
demonstrating the economic value of AT278 in combination with an innovative
AID system.

"This FDA response, coupled with our Phase 1 data, means that we are on track
to commence our Phase 2 trial next year, once further financing has been
secured, options for which are already being assessed. We are aiming to
establish a new frontier for the treatment of diabetes, and to bring more
accessible next generation treatment options, that simplify care and improve
outcomes for people living with diabetes."

-ENDS-

For more information, please contact:

 

 Arecor Therapeutics plc                                 +44 (0) 1223 426060

Dr Sarah Howell, Chief Executive Officer

David Ellam, Chief Financial Officer                   info@arecor.com

 Singer Capital Markets Advisory LLP (NOMAD and Broker)  +44 (0) 20 7496 3000
 Phil Davies, Sam Butcher

 Vigo Consulting                                         +44 (0) 20 7390 0230
 Melanie Toyne-Sewell, Rozi Morris

                                                         arecor@vigoconsulting.com

Notes to Editors

 

About Arecor
Arecor Therapeutics plc is a clinical stage biopharmaceutical company focused
on drug development and delivery in diabetes and other cardiometabolic
diseases. The Company is applying its proprietary technology platform,
Arestat®, to develop a portfolio of proprietary products, as well as working
with leading pharmaceutical and biotechnology companies to deliver therapeutic
products. Its lead product is AT278, the only ultra-concentrated (500U/mL)
ultra-rapid acting insulin. Arecor is also developing a novel oral delivery
platform for peptides (e.g. GLP-1 receptor agonists) targeting the obesity and
diabetes markets. The Company is listed on AIM (AIM: AREC) and is based in
Cambridge, UK.  For further details please see www.arecor.com
(http://www.arecor.com) .

Arecor® and Arestat® are registered trademarks of Arecor Limited.

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