REG - Arecor Therapeutics - Headline results from Phase I trial of AT247

Arecor TherapeuticsAnnouncement

11/10/2022 07:16

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RNS Number : 4116C  Arecor Therapeutics PLC  11 October 2022

Arecor Therapeutics plc

("Arecor", the "Company" or the "Group")

 

HEADLINE RESULTS FROM PHASE I CLINICAL TRIAL OF ULTRA-RAPID ACTING INSULIN
CANDIDATE AT247 DEMONSTRATE SIGNIFICANTLY ACCELERATED INSULIN ABSORPTION AND
EARLY EXPOSURE COMPARED TO GOLD STANDARD INSULINS NOVOLOG® AND FIASP®

 

-     AT247 delivers significantly accelerated insulin absorption and
early exposure (PK profile) compared with NovoLog® and Fiasp®, meeting
co-primary endpoint

-      AT247 delivers a statistically significant superior glucose
lowering effect compared with NovoLog® supporting the accelerated absorption
and early exposure PK profile

-      AT247 demonstrated a similar PD profile to Fiasp®. The
statistically superior co-primary endpoint was not met

-      AT247 shown to be safe and efficacious when delivered by
continuous subcutaneous (SC) infusion

-      Further supports potential to enable more effective disease
management for people with Type I diabetes via fully automated closed loop
insulin pump delivery (artificial pancreas)

 

Cambridge, UK, 11 October 2022: Arecor Therapeutics plc (AIM: AREC), the
biopharmaceutical company advancing today's therapies to enable healthier
lives, today announces headline results from the second Phase I clinical trial
of its ultra-rapid acting insulin, AT247, which support its potential to
facilitate a fully closed loop artificial pancreas.

 

AT247 is a 100U/mL ultra-rapid acting novel formulation of insulin that has
been designed to accelerate the absorption of insulin post injection. The
superior pharmacokinetics / pharmacodynamics ("PK"/"PD") profile of a single
dose of AT247 compared with gold standard insulins NovoLog® and Fiasp® has
been previously demonstrated in a Phase I study.

 

This second clinical study further confirms that AT247 has a superior PK
profile compared with NovoLog® and Fiasp®, showing a statistically
significant difference meeting the trial's co-primary endpoint. AT247 also
demonstrated a statistically superior early glucose lowering effect in the
trial's second primary endpoint compared with NovoLog® which was calculated
from baseline corrected Incremental AUC GIR (Glucose Infusion rate) 0-60min
(mg/kg) during post-hoc analysis. In addition, AT247 demonstrated a similar
glucose lowering profile to Fiasp®, however it did not meet superiority for
this endpoint within this study. The trial further demonstrated that AT247 can
be safely and effectively delivered via continuous SC infusion using an
insulin pump.

 

With a superior PK profile and promising PD results, this study supports the
potential that AT247 can enable even more effective disease management for
people with Type I diabetes using fully automated delivery of insulin via a
pump in closed loop mode.

 

Dr Victoria Mirza, Principal Investigator for the ARE-AT247-103 clinical
trial, said: "AT247 has clearly demonstrated faster insulin absorption,
superior to Fiasp® and NovoLog(®) when delivered by continuous infusion via
an insulin pump. With its PK profile, AT247 has the potential to significantly
improve blood glucose control when delivered via insulin pump and be an
important next step in enabling the development of a fully closed
loop/artificial pancreas system for people living with diabetes."

 

Sarah Howell, Chief Executive Officer of Arecor, said: "These results show,
once again, that AT247 has a stronger overall profile than the rapid acting
insulins currently available to patients and they reinforce our belief in its
potential to facilitate a fully closed loop artificial pancreas, a potentially
life changing treatment option for people living with diabetes. The successful
completion of this trial, the first to investigate the potential of AT247 when
delivered by subcutaneous infusion via an insulin pump over a period of 3
days, is an important milestone for Arecor. This study further demonstrates
the superior pharmacokinetic profile of AT247 with accelerated insulin
absorption and exposure compared to two gold standard insulins available
today. We will also continue to review the promising glucose lowering effect
for AT247, which achieved superiority compared with NovoLog®.  We look
forward to analysing the data in detail and defining our future clinical
development plan."

 

In the double-blind, randomised, three-way cross over Phase I clinical study
in 24 male and female participants with Type I diabetes, the pharmacokinetics
(PK) and pharmacodynamics (PD) and safety of AT247 were compared with those of
NovoLog® and Fiasp®, currently available rapid acting insulin treatments,
when delivered over 3 days by insulin pump. In this cross over study the PK/PD
profiles following a s.c. bolus dose of 0.15 U/Kg AT247, NovoLog® and
Fiasp®, delivered by insulin pump, were compared in a euglycemic clamp
setting.  The basal rate of insulin dosing was set at 0.02 U/Kg/Hr during the
clamp period.  No safety signals were detected.

 

Detailed data from the trial will be submitted for presentation at a future
international diabetes conference.

 

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 (http://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

 Mo Noonan, Communications                        Tel: +44 (0) 7876 444977

                                                  Email: mo.noonan@arecor.com

 Panmure Gordon (UK) Limited (NOMAD and Broker)   Tel: +44 (0) 20 7886 2500

 Freddy Crossley, Emma Earl (Corporate Finance)

 Rupert Dearden (Corporate Broking)

 Consilium Strategic Communications
 Chris Gardner, David Daley, Angela Gray          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 formulation 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 enhanced formulations of their 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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