04.06.2014 18:30:00
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Adocia to Present Successful Clinical Results for BioChaperone® Lispro and BioChaperone Combo at the American Diabetes Association 74th Scientific Sessions on June 15th 2014
Regulatory News:
ADOCIA (Paris:ADOC) (Euronext Paris: FR0011184241 - ADOC) announced today that two posters on the company’s research in diabetes have been accepted for presentation at the 74th Scientific Sessions of the American Diabetes Association (ADA) which will take place in San Francisco, CA from June 13 – 17.
The annual meeting of the ADA is the largest worldwide scientific meetings for clinicians and researchers involved in diabetes. During this meeting, Dr. Tim Heise, MD (Profil Neuss), medical advisor to Adocia for insulins, will present two posters on final phase 2 clinical results of Adocia’s two lead insulin products, BioChaperone® Ultra-Fast-Lispro and BioChaperone Combo.
"We are very pleased to share the complete clinical data for BioChaperone Lispro and BioChaperone Combo. It is clear from these results that our products are competitive with both the ultra-fast insulin and the insulins combo from Novo Nordisk,” said Olivier Soula, R&D Director and Deputy General Manager of Adocia. "We are convinced that insulin treatments will undergo significant evolution in the coming years, ultra-fast insulins should replace fast-acting insulin analogs and insulins combos should supplant insulin analogs premixes.”
BioChaperone Lispro is an ultra-fast formulation of insulin lispro (Eli Lilly’s Humalog®), which aims to improve prandial glycemic control for patients under insulin therapy. BioChaperone Lispro presents an action profile closer to the physiological prandial insulin response compared to insulin analogs. Adocia will present detailed Pharmacokinetic (PK) and Pharmacodynamic (PD) profiles for this product, obtained in a phase IIa clinical trial conducted on 36 type 1 diabetics versus Humalog.
Presentation of the poster 78-LB "The Ultra-Rapid BioChaperone Insulin Lispro shows a Faster Onset of Action and Stronger Early Metabolic Effect than Native Insulin Lispro” in category 01-B Clinical Therapeutics/New Technology–Insulins
Sunday Jun 15, 2014 12:00 PM - 2:00 PM Pacific Time
BioChaperone Combo is a unique combination of two insulin analogs, glargine, the gold standard of basal insulins (Sanofi’s Lantus®) and lispro, one of the best-selling prandial insulins (Eli Lilly’s Humalog®). BioChaperone Combo allows patients to limit the number of daily injections to two or even one meanwhile improving glycemic control compared to a Premix. BioChaperone Combo is the only glargine-based combination tested in clinics. Adocia will present detailed PK and PD profiles for this product obtained in a phase I/II clinical trial conducted on 20 type 1 diabetics versus HumalogMix 25.
Presentation of the poster 83-LB "Pharmacokinetic (PK) and Pharmacodynamic (PD) Characteristics of BioChaperone Combo (BC Combo), the First Fixed Combination of Glargine and Lispro, in Type 1 Diabetes” in category 01-B Clinical Therapeutics/New Technology–Insulins
Sunday Jun 15, 2014 12:00 PM - 2:00 PM Pacific Time
About the ADA Scientific Sessions
The annual meeting of the
ADA is the largest diabetes meeting in the world, bringing together
nearly 18,000 participants — including more than 14,000 clinicians and
researchers from the U.S. and 117 countries. The 5-day annual meeting
features timely and significant advances in basic science and the
prevention, diagnosis, and treatment of diabetes. There are over 3,000
original presentations which include symposia, oral abstract sessions,
meet the expert sessions, interest group discussions, guided audio
poster tours, and poster presentations. It also includes approximately
175 exhibitors showcasing the latest in diabetes-related products,
services, and technology available to health care professionals. For
more information, go to http://www.diabetes.org.
About diabetes
Diabetes is a chronic condition in which the
person has high blood glucose (hyperglycemia), either because insulin
production is inadequate, or because the body's cells do not respond
properly to insulin, or both. Over time, chronic hyperglycemia
contributes to disease progression and results in macrovascular and
microvascular complications. Worldwide, more than 382 million
individuals are currently suffering from diabetes, with a forecast of
592 million individuals by 2035, i.e. an average increase of 55%, and an
increase of as much as 70% in emerging countries. (Source: International
Diabetes Federation, 2013). All type 1 diabetic patients require insulin
to manage their disease. In the case of type 2 diabetes, disease
intensification also leads most patients to use insulin.
About BioChaperone Lispro
BioChaperone Lispro is an
ultra-fast formulation of insulin analog Lispro (Eli Lilly’s Humalog®).
Available prandial insulin treatments act with a delay of 15 to 30 min
after injection, which fails to replicate the immediate secretion of
insulin observed in healthy individuals during a meal. This delay
results in an unsatisfactory glycemic control (hyper and hypoglycemias),
itself responsible for long-term complications and weight gain.
Ultra-fast BioChaperone Lispro aims to accelerate the action of insulin
lispro, thus improving prandial glycemic control for insulin-dependent
diabetics. In a Phase IIa clinical trial, BioChaperone Lispro showed
significant acceleration of its onset of action compared to insulin
lispro.
About BioChaperone Combo
BioChaperone Combo is a
combination, in one product of two insulin analogs, glargine, the gold
standard of basal insulins (Sanofi’s Lantus) and lispro, one of the best
sellers in prandial insulins (Eli Lilly’s Humalog®).
Combining basal and prandial insulins in one injection is crucial to
improve both compliance and treatment comfort for diabetic patients. To
date, combining glargine to a prandial insulin was considered
impossible, due to physical chemical incompatibilities between both
types of products. While premix products are available, they do not
match the efficacy profile of a double injection. BioChaperone Combo
allows to combine both products in one single injection, while
preserving their respective efficacy profiles. BioChaperone Combo showed
superiority to HumalogMix (Eli Lilly’s lispro-based premix product) both
in terms of onset of action and duration of action. In particular, the
duration of action of BioChaperone Combo suggests that it could be used
once-a-day, while available Premix products require two injections daily.
About Adocia
To be a global leader in the delivery of
insulins and therapeutic proteins
Adocia is clinical-stage
biotechnology company that specializes in the development of innovative
formulations of already-approved therapeutic proteins. It has a
particularly strong expertise in the field of insulins. Adocia’s
proprietary BioChaperone® technological platform is designed
to enhance the effectiveness and safety of therapeutic proteins and
their ease of use for patients.
Adocia has successfully completed
two Phase I and II studies of a fast-acting human insulin formulation,
two Phase I and II studies of an ultra-fast-acting insulin lispro and a
Phase I/II of a unique combination of insulin glargine, the
gold-standard of basal insulin and insulin lispro, a fast-acting insulin
analog. Dose-escalation Phase IIa studies of all three products are
scheduled for 2014.
The company has also obtained positive results
in a Phase I/II study of a diabetic-foot-ulcer-healing product based on
PDGF-BB (Platelet-Derived Growth-Factor BB). A phase III clinical trial
dossier has been filed with Indian regulatory authorities, and the trial
is expected to start in 2014.
Adocia has extended its activities to
the formulation of monoclonal antibodies, which are gold-standard
biologics for the treatment of various chronic pathologies (cancer,
inflammation, etc.). Adocia is engaged in collaborative programs with
two major pharmaceutical companies in this field.
Fighting cancer with targeted treatments
DriveIn®
is a nanotechnology which is remarkably efficient in delivering active
compounds into cancer cells. This new platform constitutes an
exceptional opportunity to enter the oncology market by improving the
efficacy of both already approved treatments and novel proprietary
molecules.
"Innovative medicine for everyone, everywhere”
Adocia’s
therapeutic innovations aim at providing solutions in a profoundly
changing global pharmaceutical and economic context, characterized by
(i) an increased prevalence and impact of the targeted pathologies, (ii)
a growing and ageing population, (iii) a need to control public health
expenditures and (iv) an increasing demand from emerging countries.
Adocia is listed on the regulated market of Euronext Paris (ISIN:
FR0011184241; Reuters/Bloomberg ticker: ADOC, ADOC.PA, ADOC.FP) and its
share price is included in the Next Biotech index.
American
Depositary Receipts representing Adocia common stock are traded on the
US OTC market under the ticker symbol ADOCY.
For more information,
visit www.adocia.com
Disclaimer
This press release contains certain
forward-looking statements concerning Adocia and its business. Such
forward-looking statements are based on assumptions that Adocia
considers to be reasonable. However, there can be no assurance that the
estimates contained in such forward-looking statements will be verified,
which estimates are subject to numerous risks including the risks set
forth in the ‘Risk Factors’ section of the Reference Document registered
by the Autorite des marches financiers on April 24, 2014 under number
R.14-020 (a copy of which is available on hhtp://www.adocia.com)
and to the development of economic conditions, financial markets and the
markets in which Adocia operates. The forward-looking statements
contained in this press release are also subject to risks not yet known
to Adocia or not currently considered material by Adocia. The occurrence
of all or part of such risks could cause actual results, financial
conditions, performance or achievements of Adocia to be materially
different from such forward-looking statements.
This press release and the information contained herein do not constitute an offer to sell or the solicitation of an offer to buy Adocia shares in any jurisdiction.
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