ADOCIA Announces the Successful Phase 1 Study for BioChaperone® Lispro with Partner Tonghua Dongbao

Rhea-AI Summary

Adocia announced positive results for BioChaperone Lispro in a Phase 1 study, confirming its accelerated absorption and efficacy compared to traditional insulin lispro. The ongoing Phase 3 studies are the last steps before submitting a marketing authorization application to Chinese authorities. BioChaperone Lispro, expected to be the first ultra-rapid insulin marketed in China by a domestic company, aims to improve the lives of over 20 million daily insulin users in a market worth over $5 billion.

Positive

• Phase 1 study confirmed accelerated absorption of BioChaperone Lispro compared to insulin lispro.
• Ongoing Phase 3 studies are the final steps before marketing authorization submission in China.
• BioChaperone Lispro expected to be first ultra-rapid insulin marketed by a Chinese company.
• $5 billion Chinese insulin market presents significant growth potential.

Negative

• None.

• Adocia’s partner, Tonghua Dongbao, announced that the primary endpoint of this Phase 1 study was reached, and the results confirmed the accelerated profile of BioChaperone Lispro in comparison to lispro.
• Ongoing Phase 3 studies are the only remaining clinical activities planned before submitting the marketing authorization file to the Chinese Regulatory Authorities.
• BioChaperone Lispro is expected to be the first analog of Ultra-Rapid Insulin to be marketed in China by a Chinese company.

LYON, France--(BUSINESS WIRE)-- Regulatory News:

Adocia (Euronext Paris: FR0011184241 – ADOC) (Paris: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 new positive results for BioChaperone^® Lispro insulin (named THDB0206 in China) with partner Tonghua Dongbao.

BioChaperone Lispro was compared with Humalog (insulin lispro) and pharmacokinetic/pharmacodynamic properties of BioChaperone Lispro were significantly faster. Moreover, BioChaperone Lispro confirmed its good tolerability and safety profiles.

“These results confirm once again the robustness of our technology and the advantages of our product in comparison to the global market leader of mealtime insulin”, said Olivier Soula, Adocia's Deputy CEO. “We would like to thank our partner Tonghua Dongbao for its rigorous execution of the clinical development plan, including on ongoing Phase 3 studies.”

Conducted in parallel of the Phases 3, this Phase 1 study was conducted in an open label, positive control, randomized, crossover trial to evaluate pharmacokinetics and pharmacodynamics of single dose of BioChaperone Lispro in healthy Chinese volunteers. The primary objective of this study was to evaluate whether a BioChaperone Lispro injection has a faster absorption and onset of action compared to an insulin Lispro injection.

Adocia licensed BioChaperone Lispro to Tonghua Dongbao for China and major Asian territories that represents 200 million people suffering from diabetes¹, with an estimated 20 million using insulin daily for their survival.

In 2021, the Chinese insulin market represented more than US$5 billion².

About BioChaperone^® Lispro

BioChaperone^® (BC) Lispro is an Ultra-Rapid Insulin obtained by combining Adocia’s proprietary BioChaperone technology with the rapid-acting market leader insulin lispro (as contained in the commercial product Humalog^®).

Distributed more rapidly into the bloodstream than previous generations of insulins, BC Lispro reduces post-meal hyperglycemic excursions that are responsible for long-term comorbidities such as retinopathy, diabetic foot ulcer, and kidney failure. Moreover, as BC Lispro is eliminated faster from the body, it may also reduce the risk of hypoglycemic events that are caused when insulin remains too long in the bloodstream after the post-meal hyperglycemia peak has declined.

On top of its direct clinical benefits, the onset of action of BC Lispro results in improved quality of life with more dose-timing flexibility at mealtime. A mealtime injection, or even right-after-mealtime, enables patients to better determine the appropriate insulin dose as the exact timing and contents of their meal are known. This avoids overdosing or delayed dosing, which can lead to hypo- or hyperglycemia respectively, and prevents the severe short and long-term consequences. It significantly reduces the stress and the mental load of those affected by insulin-dependent diabetes and their caretakers which is important in day-to-day life.

Currently, the only drugs providing similar effects in the world are Fiasp^® from Novo Nordisk Co. and Lyumjev^® from Eli Lilly and Company. Fiasp^® and Lyumjev^® are not marketed in China.

Since licensing BC Lispro to Tonghua Dongbao in 2018, Adocia has already received $15 million in upfront fees and a milestone payment for the first patient dosed in Phase 3. The agreement also includes up to $30 million additional development milestones and double-digit royalties on sales to be paid to Adocia by Tonghua Dongbao.

BC Lispro is currently being studied in a large Phase 3 program that consists of two studies treating people with Type 1 and Type 2 diabetes in more than 100 clinical centers across China and will enroll a total of c. 1,300 patients. The aim of this program is to demonstrate safety and efficacy of BC Lispro in comparison to standard of care (Humalog^®). Results of this program will then be submitted to the Chinese Regulatory Authorities by Tonghua Dongbao to obtain marketing authorization.

BC Lispro is patent protected until 2033.

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. To date, 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 2,800 employees and a turnover of approximately US$513 million³. It has been listed on the Shanghai Stock Exchange since 1994, with a market capitalization of US$2.6 billion⁴.

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 Euronext^TM 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 21, 2022 (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.

¹ International Diabetes Federation, 10Atlas, 2021
² China Industry Information website
³ 2021 year-end exchange rate (637.57 CNY per 100 USD) applied for 2021 turnover
⁴ Exchange rate on 23 Dec 2022 (698.10 CNY per 100 USD) applied for the current market capitalization

View source version on businesswire.com: https://www.businesswire.com/news/home/20221228005300/en/

Adocia

Gérard Soula

CEO

contactinvestisseurs@adocia.com

Tel : +33 4 72 610 610

www.adocia.com

Ulysse Communication

Adocia Press and Investors Relations

Pierre-Louis Germain

plgermain@ulysse-communication.com / + 33 (0)6 64 79 97 51

Margaux Puech Pays d’Alissac

mpuech@ulysse-communication.com / +33 (0)7 86 16 01 09

Bruno Arabian

barabian@ulysse-communication.com / +33 (0)6 87 88 47 26

Source: ADOCIA

FAQ

What are the results of the Phase 1 study for ADOCY?

The Phase 1 study for ADOCY's BioChaperone Lispro confirmed its faster absorption and onset of action compared to traditional insulin lispro.

What is the next step for BioChaperone Lispro after the Phase 3 studies?

After the Phase 3 studies, a marketing authorization application will be submitted to Chinese regulatory authorities.

How many patients are involved in the Phase 3 studies of BioChaperone Lispro?

Approximately 1,300 patients are enrolled in the Phase 3 studies for BioChaperone Lispro.

What is the market potential for BioChaperone Lispro in China?

The Chinese insulin market is valued at over $5 billion, with significant potential for BioChaperone Lispro to cater to the 20 million daily insulin users.