Arecor Therapeutics PLC FDA clearance of IND (1925L)
September 09 2021 - 1:00AM
UK Regulatory
TIDMAREC
RNS Number : 1925L
Arecor Therapeutics PLC
09 September 2021
Arecor Therapeutics plc
("Arecor" or the "Group")
FDA CLEARANCE OF Investigational New Drug application for AT247,
AN ULTRA-RAPID INSULIN FOR THE TREATMENT OF DIABETES
Cambridge, UK, 9 September 2021. Arecor Therapeutics plc (AIM:
AREC), the biopharmaceutical group advancing today's therapies to
enable healthier lives, today announces U.S. Food and Drug
Administration (FDA) clearance of the Group's Investigational New
Drug (IND) application for AT247, the Group's proprietary wholly
owned ultra-rapid insulin for the treatment of diabetes.
The IND supports a Phase I clinical trial in the US in
approximately 24 participants with type I diabetes, to further
explore the clinical benefits of AT247. The trial is a double
blind, randomised, three way crossover study comparing the
pharmacokinetics (PK) and pharmacodynamics (PD) of AT247 with Novo
Nordisk's NovoRapid(R) and Fiasp(R), two market-leading rapid
acting insulin treatments. It will be the first trial to
investigate the product's potential when delivered by continuous
subcutaneous infusion via insulin pump over a period of 3 days and
follows a previous successful first-in-man clinical study.
AT247, a novel formulation of insulin, aims to accelerate
insulin absorption, post injection, to enable more effective
management of blood glucose levels for people living with diabetes.
AT247 has the potential to significantly improve post prandial
glucose control so avoiding episodes of both hypo and
hyperglycemia. In a recently published European Phase I clinical
study in Type I diabetic patients, AT247 exhibited an earlier
insulin appearance, exposure, and offset, with corresponding
enhanced early glucose-lowering effect compared with NovoRapid(R)
and Fiasp(R). This Phase I clinical data suggests that AT247 may
also facilitate a fully closed loop artificial pancreas, a
potentially life changing treatment option for people living with
diabetes. This trial is expected to complete in 2022.
Sarah Howell, Chief Executive Officer of Arecor, said: " FDA
clearance of the IND for AT247 marks an important milestone for
this product, which has been enabled with our proprietary
formulation technology platform, Arestat(TM). We look forward to
initiating the next clinical study, which will be our first study
in the US, and has been designed to further demonstrate the
superiority of AT247 compared to current market leaders. With c.
463 million people living with diabetes world-wide, of which
approximately 56 million are insulin users, the management of blood
glucose control remains a serious issue. We believe that AT247 has
the potential to help patients lead healthier lives."
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
group 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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