TIDMAREC
RNS Number : 2274M
Arecor Therapeutics PLC
20 September 2021
Arecor Therapeutics plc
("Arecor", the "Company" or the "Group")
ARECOR ANNOUNCES POSITIVE HEADLINE RESULTS FROM FIRST PHASE I
CLINICAL TRIAL OF
AT278 ULTRA-CONCENTRATED ULTRA-RAPID ACTING INSULIN CANDIDATE
FOR DIABETES
- AT278 delivers significantly accelerated PK/PD profile compared to NovoRapid (R)
- Potential to be first concentrated (500U/mL) ultra-rapid
acting insulin product enabling miniaturisation of next generation
insulin delivery devices
- Potential to enable more effective disease management for
insulin resistant patients requiring >200 units of insulin per
day
Cambridge, UK, 20 September 2021. Arecor Therapeutics plc (AIM:
AREC) , the biopharmaceutical company advancing today's therapies
to enable healthier lives, today announces that its
ultra-concentrated ultra-rapid acting insulin, AT278 met all of its
primary and secondary endpoints with positive headline results from
the Phase I clinical trial.
Sarah Howell, Chief Executive Officer of Arecor, said: "The
successful completion of our AT278 Phase I clinical trial is an
important milestone for Arecor. AT278 has the potential to disrupt
the market for insulin treatment in people with diabetes, as the
first concentrated, yet rapid acting, insulin - a critical enabler
in the development of next generation miniaturised insulin delivery
systems. The study had been designed to achieve PK/PD equivalence
with a comparable dose of lower concentration NovoRapid (R). The
achievement of a superior PK/PD profile goes beyond our
expectations and for that we are delighted.
"These positive data for AT278, the second product in our
diabetes franchise, follow the earlier positive results from the
Phase I clinical trial of AT247, our ultra-rapid acting insulin for
diabetes. Together they position Arecor with a unique combination
of ultra-concentrated and ultra-rapid insulin candidates offering
the potential to meet the broad needs of patients across the
growing diabetes market."
AT278 is an ultra-concentrated (500 U/mL) novel formulation of
insulin that has been designed to accelerate the absorption of
insulin post injection, even when delivered at a high
concentration, and hence via a lower injection volume. Currently,
there are no concentrated (>200 U/mL) rapid acting insulin
products on the market and therefore AT278 has the potential to be
the first such product available to patients. It has the potential
to enable more effective management of blood glucose levels to the
increasing number of people with diabetes with high daily insulin
requirements (>200 units/day) whilst maintaining the convenience
and compliance benefits of being able to deliver these high insulin
doses in a lower injection volume via a single injection. In
addition, a truly rapid acting concentrated insulin is also a
critical step towards the advancement and miniaturisation of the
next generation of insulin delivery devices.
In the double-blind, randomised, two-way crossover Phase I
clinical study in 38 participants with Type I diabetes, the
pharmacokinetics (PK), pharmacodynamics (PD) and safety of a single
subcutaneous (SC) dose of 0.3 U/Kg AT278 (500 U/mL) were compared
with those of a single SC dose of 0.3 U/Kg NovoRapid(R) (100 U/mL),
a currently available gold standard rapid acting insulin treatment,
in a euglycemic clamp setting. The trial met the primary endpoint
of non-inferiority with respect to glucose lowering action as
compared with NovoRapid(R). In addition to meeting this primary
endpoint, AT278 (500 U/mL) also demonstrated a significantly
accelerated early PK/PD profile compared to NovoRapid(R) (100
U/mL), despite a 5-fold increase in concentration. No safety
signals were detected.
These Phase I clinical results in diabetes patients are
clinically significant, and, as currently there are no concentrated
(>200U/mL) rapid acting insulin products on the market, AT278
has the potential to be the first such product available to
patients. AT278, enabled by Arecor's proprietary Arestat(TM)
technology platform, has been developed to overcome the challenge
whereby increasing the concentration of insulin typically results
in a slower absorption and delayed glucose lowering profile.
Professor Thomas Pieber, Principal Investigator for the
ARE-278-102 clinical trial, said: "AT278 has clearly demonstrated
faster insulin absorption with an accelerated Pharmacokinetic (PK)
and Pharmacodynamic (PD) profile compared to the lower
concentration NovoRapid(R) . With this superior PK/PD profile,
AT278 has the potential to significantly improve post prandial
glucose control as well as reducing the injection volume and/or
number of daily injections for people with diabetes that have a
high daily insulin need. In addition, AT278 has the potential to
catalyse the development of miniaturised insulin delivery device s
where the size of existing devices is a barrier to use for many
patients."
The next step will be further clinical investigation of the
potential benefits of the ultra-rapid acting profile of AT278 to
further optimise the positive results obtained in this first
clinical study.
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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