REG - Arecor Therapeutics - Arecor presents positive AT278 data at EASD

Arecor TherapeuticsAnnouncement

11/09/2024 07:00

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RNS Number : 6615D  Arecor Therapeutics PLC  11 September 2024

Arecor Therapeutics plc

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

 

ARECOR PRESENTS POSITIVE DATA FROM PHASE I CLINICAL TRIAL OF
ULTRA-CONCENTRATED ULTRA-RAPID ACTING INSULIN AT278 IN OVERWEIGHT AND OBESE
PEOPLE WITH TYPE 2 DIABETES IN LATE-BREAKING ORAL PRESENTATION AT EASD 2024

 

-      AT278 delivers significantly accelerated early PK/PD profile
compared with NovoRapid® in people with Type 2 Diabetes and high BMI

-      Results confirm previous findings in people with Type 1 diabetes
and show that AT278 can maintain the faster action profile irrespective of
diabetes type and BMI

-      Critical enabler in development of miniaturised next-generation
insulin pumps

-      Favourable safety profile with no safety signals detected

 

Cambridge, UK, 11 September 2024: Arecor Therapeutics plc (AIM: AREC), the
biopharmaceutical group advancing today's therapies to enable healthier lives,
today presents positive results from its Phase I clinical trial of the
ultra-concentrated, ultra-rapid acting insulin candidate, AT278, in Type 2
diabetics with a high body mass index (BMI), at the 60(th) Annual Meeting of
the European Association for the Study of Diabetes (EASD
(https://www.easd.org/programme-2024.html) ) in Madrid.

 

AT278 (500 U/mL) is an ultra-concentrated, ultra-rapid acting, novel
formulation of insulin that accelerates the absorption of insulin post
injection, even when delivered at a high concentration, and hence a lower
injection volume. With no concentrated (>200 U/mL), rapid acting insulins
on the market, AT278 has potential to be the first, and only, insulin
available to the growing number of patients with high daily insulin
requirements and to be a critical enabler of next-generation miniaturised and
longer wear insulin pumps.

 

Professor Thomas Pieber, Principal Investigator for the ARE-278-104 study,
said: "The clinical significance of these findings is considerable. AT278's
accelerated early PK/PD profile compared with NovoRapid® in overweight and
obese people with type 2 diabetes confirms previous findings in people with
type 1 diabetes and shows that AT278 can maintain its faster action profile
irrespective of diabetes type and BMI. The faster onset and stronger early
glucose-lowering effect, consistent across BMI subgroups, indicate that AT278
could provide significantly better post-prandial glucose control and improved
convenience for anyone with diabetes who has a high daily insulin need. It
also, clearly, can be a catalyst in the progress towards miniaturised
next-generation insulin pumps, where the size of existing devices remains a
major hurdle for development."

 

Sarah Howell, Chief Executive Officer of Arecor, added: "Despite the
improvements in outcomes among people with diabetes who use insulin pumps and
automated insulin delivery systems they are still used by only 40% of people
with Type I diabetes and less than 10% of people with Type 2 diabetes in the
US where use is greatest. A critical barrier to further uptake is the size and
short duration of wear of existing insulin pumps. We believe the results we
are presenting today clearly demonstrate that AT278 has the potential to break
this barrier and make miniaturised, longer wear insulin pumps a reality and
thereby meet the needs of patients, and of device companies as they seek to
grow a market which is valued at c. $5.5 billion today and forecast to reach
more than $15.8bn by 2030."

 

In the double-blind, randomised, two-way crossover study, the pharmacokinetic
(PK)/pharmacodynamic (PD) and safety profiles of a single subcutaneous (SC)
dose of 0.5 U/kg AT278 (500 U/mL) were compared with those of a single SC dose
of 0.5 U/kg NovoRapid® (100 U/mL), a currently available gold standard,
rapid acting insulin, in 41 participants with Type 2 diabetes and a median BMI
of 29.7 kg/m(2). The trial was conducted in a glucose clamp setting at the
Medical University of Graz and Joanneum Research in Austria, an
internationally recognised centre of excellence in the field of diabetes
research.

 

The PK/PD profile for AT278 was accelerated compared with NovoRapid®. AT278
demonstrated a 1.7-fold (95% CI 1.32; 2.96) higher glucose-lowering effect
within the first 60 minutes which was statistically superior to NovoRapid®
(p< 0.0001). The glucose-lowering effect remained higher up to 2 hours
post-dosing (treatment ratio [95% CI] 1.19 [1.02; 1.39]). AT278 showed a
faster onset of glucose-lowering effect, with a 5-minute earlier onset of
action and 25-minute earlier t(Early50%GIRmax) than NovoRapid®. It also
showed a faster onset of insulin exposure compared with NovoRapid, with a
5-minute faster insulin appearance and 24-minute faster t(Early50%Cmax).
Insulin exposure with AT278 was 1.5-fold higher within the first 60 minutes
(95% CI 1.28; 1.71). The superior early glucose-lowering effect of AT278 was
maintained when the population was divided into BMI subgroups.

 

Both insulins were well tolerated. Adverse events were mostly mild to moderate
and not related to the study drugs.

 

Arecor is continuing to explore funding options for AT278, including but not
limited to co-development arrangements, to conduct a clinical pump study to
further demonstrate the potential of AT278 to disrupt the market by enabling
the next generation of truly miniaturised, longer-wear insulin pumps, a key
focus for patients, physicians and the industry.

 

Headline data from this clinical trial were previously announced by the
Company in May 2024.

 

-ENDS-

 

 

 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 (mailto:info@arecor.com)

 Panmure Liberum Limited (NOMAD and Broker)
 Freddy Crossley, Emma Earl (Corporate Finance)  Tel: +44 (0) 20 7886 2500

 Rupert Dearden (Corporate Broking)

 WG Partners LLP (Financial Advisor)
 Nigel Barnes, Satheesh Nadarajah                Tel: +44 (0)203 705 9321

 David Wilson, Claes Spang

 ICR Consilium
 Chris Gardner, David Daley, Lindsey Neville     Tel: +44 (0) 20 3709 5700

                                                 Email: arecor@consilium-comms.com (mailto:arecor@consilium-comms.com)

 

 

Notes to Editors

The abstract, "Pharmacokinetic and pharmacodynamic properties of highly
concentrated insulin aspart AT278 U500 in overweight and obese people with
type 2 diabetes" is available on the EASD 2024 website.

 

About the EASD

The European Association for the Study of Diabetes (EASD) is a non-profit,
medical scientific association, founded in 1965 to encourage and support
research in the field of diabetes, the rapid diffusion of acquired knowledge
and to facilitate its application. EASD holds its Annual Meeting in a
different European city each year with more than 15,000 delegates from over
130 countries attending. The scientific programme includes more than 1,200
talks and presentations on the latest results in diabetes research by leading
experts in the field.

 

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 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
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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