TIDMAREC
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(R) AND FIASP(R)
- AT247 delivers significantly accelerated insulin absorption
and early exposure (PK profile) compared with NovoLog(R) and
Fiasp(R), meeting co-primary endpoint
- AT247 delivers a statistically significant superior glucose
lowering effect compared with NovoLog(R) supporting the accelerated
absorption and early exposure PK profile
- AT247 demonstrated a similar PD profile to Fiasp(R). 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(R) and Fiasp(R) 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(R) and Fiasp(R), 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(R) 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(R),
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(R) and NovoLog(R) 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(R). 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(R) and
Fiasp(R), 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(R) and Fiasp(R), 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
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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