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A first subject has been treated in the CT046-ADO05 clinical trial. Last Patient Last Visit is planned for December 2022. Préliminary results expected in Q1 2023.
Together with CT047 and CT048, CT046 results should be submitted to the Chinese Drug Agency by Tonghua Dongbao in order to obtain the authorization to start a phase 3 pivotal program
LYON, France, May 18, 2022--(BUSINESS WIRE)--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, announced today the first subject treated in the BioChaperone® Combo ("BC Combo") CT046 clinical study.
CT046 is one of the three clinical studies – together with CT047 and CT048 - financed by Tonghua Dongbao and conducted by Adocia in Germany. Final approval by the German (BfArM) regulatory authorities to conduct these studies has been communicated in a press release on 2022, April 11th.
CT046 is a trial investigating the pharmacodynamics of BC Combo compared with Humalog® Mix25 and simultaneous injections of Humalog® and Lantus® in healthy chinese volunteers.
CT047 will be comparing the pharmacodynamics and pharmacokinetics of BC Combo and Lantus® and Humalog® in subjects with Type 1 Diabetes.
CT048 will be investigating the dose linearity and safety of BC Combo in subjects with Type 2 Diabetes
"We are delighted with the progress of this clinical program conducted by Adocia in Germany and fully funded by our partner Tonghua Dongbao," said Olivier Soula, Adocia's Deputy CEO & Head of R&D. "The preliminary results of these studies on BC Combo, our combination of rapid-acting (lispro) and long-acting (glargine) modern insulins, are expected in Q1 2023 and should provide a solid basis for a direct entry into phase 3 in China".
This program on BC Combo is part of the license to Tonghua Dongbao, signed in 2018. Under the terms of this agreement, Adocia received a $40 million upfront fee and is eligible for up to $50 million in milestone payments plus double-digit royalties on future sales of the product in China and other Tonghua Dongbao territories.
About BioChaperone® Combo
BioChaperone® Combo (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 the commercial product 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).
BC Combo offers a number of advantages over traditional premixes: it reduces the level of postprandial hyperglycemia and the risk of hypoglycemia, and provides better 24-hour basal control.
Currently, the only premix product co-formulating a long-acting and a rapid-acting insulin is Novo Nordisk fixed combination of degludec and aspart (Novojia® or Ryzodeg®). Ryzodeg® is marketed since 2012 in many territories such as the USA, Europe and Japan but it has only been approved in China since May 2019 under Novojia® brand name.
BC Combo is patent protected until 2038.
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. Founded in 1985, Tonghua Dongbao was the first Chinese company which developed and commercialized insulins. Till now it has advanced a pipeline consisting of insulins / insulin analogs, GLP-1RA, novel drugs, etc., for diabetes and other metabolic diseases. Currently Tonghua Dongbao has more than 2,700 employees and a turnover of approximately US$500 million. It has been listed on the Shanghai Stock Exchange since 1994, with a market capitalization of US$3.3 billion.
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 three 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® Islets, an immunoprotective biomaterial for cell transplantation with a first application in pancreatic cells transplantation for patients with "brittle" diabetes.
Adocia holds more than 25 patent families.
Based in Lyon, the company has 115 employees. Adocia is listed on the EuronextTM Paris market (Euronext: ADOC; ISIN: FR0011184241).
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 20, 2021 (a copy of which is 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.
This press release and the information contained herein do not constitute an offer to sell or the solicitation of an offer to buy Adocia’s shares in any jurisdiction.
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