- Three clinical trials on BioChaperone® Combo (THDB0207) were
conducted in Germany on subjects with type 1 diabetes, type 2
diabetes and on healthy volunteers with Chinese origin
- In comparison with premixed standard of care (Humalog® Mix25),
trials successfully demonstrated:
- Good safety and tolerability profile
- Faster effect, that could be translated in reduced
post-prandial hyperglycemia
- Improved basal control
- Reduced over-exposure that could limit hypoglycemia
- Data generated will be submitted to the CDE to support the
application for the next clinical development phase
Regulatory News:
Adocia (Euronext Paris: FR0011184241 – ADOC), a clinical-stage
biopharmaceutical company focused on the research and development
of innovative therapeutic solutions for the treatment of diabetes
and other metabolic diseases, announces that its partner Tonghua
Dongbao releases today positive results on the three clinical
studies conducted on BioChaperone® Combo THDB0207 (“BC Combo”)
formulation containing insulin glargine and insulin lispro from
Tonghua Dongbao.
Conducted by Adocia in Germany, these studies were fully funded
by Tonghua Dongbao, the Chinese insulin leader to whom BC Combo was
licensed in 2018. These studies were approved by the German Health
Authority (BfArM1), as well as by the Chinese Regulatory
Authorities (CDE2), as part of a Chinese IND3. As per these
interactions, the data generated on the three studies will be
submitted to the CDE and used to support the application to enter
the next clinical development phase.
“Our sales in insulin analogues have been recording an
impressive growth in recent years, and we are extremely pleased
about the prospect of soon adding BioChaperone® Combo to our
portfolio of innovative insulins," says Dr Chunsheng Leng, Chairman
and CEO of Tonghua Dongbao. "These three successful studies bring
the product one step closer to being available to Chinese people
suffering from diabetes".
"I would like to express our gratitude to Tonghua Dongbao for
entrusting us with the conduct of these studies," says Olivier
Soula, Chief Executive Officer of Adocia. "I am particularly
pleased with the results of these clinical studies, which underline
the potential of BC Combo to bring additional medical value to
people with diabetes, seeking once- or twice-daily insulin
injections, ensuring the basal and prandial glycemic control.
Tonghua Dongbao can count on our full support to continue the
successful development of BC Combo.”
Results
The following trials were conducted and all three were
positives:
- A Trial Investigating the Dose Linearity and Safety of
BioChaperone® Combo THDB0207 in Subjects with Type 2 Diabetes
(NCT05373212)
- A Trial Investigating the Pharmacodynamics of BioChaperone®
Combo THDB0207 Compared with Humalog® Mix25 and Simultaneous
Injections of Humalog® and Lantus® in Healthy Chinese Volunteers
(NCT05373186)
- A Trial Comparing the Pharmacodynamics and Pharmacokinetics of
BioChaperone® Combo THDB0207 and Lantus® and Humalog® in Subjects
with Type 1 Diabetes (NCT05373199)
These three trials demonstrated that BC Combo is effective, with
typical characteristics of a combination of long-acting and
rapid-acting insulins, and can thus ensure glycemic control during
postprandial and fasting phases.
Trials were conducted in comparison to Humalog® Mix, Humalog®
and Lantus®, in people with type 1 diabetes, type 2 diabetes or on
healthy volunteers with Chinese origin.
Compared with Humalog® Mix, BC Combo has a faster effect, that
could be translated in reduced post-prandial hyperglycemia. BC
Combo has a potential for enhanced fasting glucose control, with an
improved 24-hour basal control. It also demonstrated a reduced
over-exposure that could limit hypoglycemia.
Those data support the goal of effective once or twice daily
dosing.
BC Combo was safe and well tolerated; no new or unexpected
safety findings were reported during the trials.
The overall assessment showed that BC Combo had a good
benefit/risk ratio, supporting its clinical development into the
next phase.
About BioChaperone® Combo
BioChaperone® Combo THDB0207 (BC Combo) is a fixed combination
of two gold standard insulins: long-acting insulin glargine (as
contained in the commercial product Lantus®) and rapid-acting
insulin lispro (as contained in Humalog®). Many patients worldwide
prefer to use fixed combinations of long and rapid acting insulins
rather than two separate products (simplicity, reduced number of
daily injections).
BioChaperone® Combo targets the premixed insulin market, which
accounts for 65% of insulin volumes in China, a country with 140
million diabetic patients.
The different clinical studies conducted confirm the potential
of BC Combo to reduce postprandial hyperglycemia and the risk of
hypoglycemia, while providing 24-hour basal control.
About Tonghua Dongbao
Tonghua Dongbao Pharmaceutical Co. Ltd, is a pharmaceutical
company in Jilin Province, China, specializing in the R&D,
manufacturing and commercialization of insulins as well as other
diabetes treatment products. Currently Tonghua Dongbao has more
than 3,000 employees and a turnover of approximately US$400
million. It has been listed on the Shanghai Stock Exchange since
1994, with a market capitalization of US$3 billion.
Tonghua Dongbao acquired development and commercialization
rights on BioChaperone® Combo and BioChaperone® Lispro in 2018 for
Asia and other Middle East territories.
About Adocia
Adocia is a biotechnology company specializing in the discovery
and development of therapeutic solutions in the field of metabolic
diseases, primarily diabetes and obesity.
The company has a broad portfolio of drug candidates based on
four proprietary technology platforms: 1) The BioChaperone®
technology for the development of new generation insulins and
products combining insulins with other classes of hormones; 2)
AdOral®, an oral peptide delivery technology; 3) AdoShell®, an
immunoprotective biomaterial for cell transplantation, with a first
application in pancreatic cells transplantation; 4) AdoGel®, a
long-acting drug delivery platform.
Adocia holds more than 25 patent families. Based in Lyon, the
company has about 100 employees. Adocia is listed on the regulated
market of EuronextTM Paris (Euronext: ADOC; ISIN:
FR0011184241).
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 as being reasonable.
However, there can be no guarantee that the estimates contained in
such forward-looking statements will be achieved, as such estimates
are subject to numerous risks including those which are set forth
in the “Risk Factors” section of the universal registration
document that was filed with the French Autorité des marchés
financiers on April 26, 2023 updated by the amendment of 26 July
2023 (D.23-0346-A01) and amendment of 13 September 2023
(D.23-0346-A02), available at www.adocia.com, in particular
uncertainties that are linked to research and development, future
clinical data, analyses, and the evolution of the economic context,
the 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 considered
as material by Adocia as of this day. The occurrence of all or part
of such risks could cause that actual results, financial
conditions, performances, or achievements of Adocia be materially
different from those mentioned in the forward-looking
statements.
1 BfArM: Bundesinstitut für Arzneimittel und Medizinprodukte,
Federal Institute for Drugs and Medical Devices 2 CDE: Center for
Drug Evaluation of the National Medical Products Administration 3
IND: Investigational New Drug
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version on businesswire.com: https://www.businesswire.com/news/home/20231023518020/en/
Adocia Olivier Soula CEO
contactinvestisseurs@adocia.com +33 (0)4 72 610 610
www.adocia.com
Ulysse Communication Adocia Relations Presse et
Investisseurs Pierre-Louis Germain Bruno Arabian
adocia@ulysse-communication.com + 33 (0)6 64 79 97 51
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