- Final dosing of the last patient concludes the Phase 3 study in
people with Type 2 diabetes, event associated with a $10 million
payment from Tonghua Dongbao to Adocia
- Phase 3 topline results are expected in H1 2025
- Granting of the Marketing Authorization will trigger an
additional $20 million milestone payment, followed by double-digit
royalties on sales
Regulatory News:
Adocia (Euronext Paris: FR0011184241 – ADOC, the “Company”), a
clinical-stage biopharmaceutical company focused on the research
and development of innovative therapeutic solutions for the
treatment of diabetes and obesity, today announced the completion
of the final dosing of the last Type 2 diabetes patient in a Phase
3 clinical trial evaluating BioChaperone® Lispro, the Company’s
novel ultra-rapid insulin.
This clinical trial is being conducted in China by Adocia's
partner, Tonghua Dongbao Pharmaceutical (Shanghai Stock Exchange:
600867), in people with Type 2 Diabetes. The final dosing of the
last Type 2 diabetes patient is associated with a milestone payment
of $10 million to Adocia. This payment will be received in the
second quarter of 2025 as per the payment terms of the Licensing
Agreement.
A second study in people with Type 1 diabetes is nearing the end
of treatment, which is expected to be in early 2025. Both Phase 3
topline results, in people with Type 1 and Type 2 diabetes, are
expected in H1 2025.
Tonghua Dongbao is expected to submit the Marketing
Authorization Application to the Chinese Centre for Drug Evaluation
(CDE) in 2025. The grant of the Marketing Authorization would lead
to an additional milestone payment of $20 million and double-digit
royalties on sales to Adocia.
Mr. Jiahong Li, Chairman of Tonghua Dongbao, said: "We
are delighted to be working with Adocia on this innovative insulin.
With the development of BioChaperone® Lispro, Tonghua Dongbao joins
the very select group of companies that are innovating in the field
of insulin. We look forward to making this novel product available
to patients in Asia in the near future”.
Olivier Soula, CEO and Co-Founder of Adocia, added:
"Knowing the challenges to develop an innovative insulin, we are
very pleased to see this large Phase 3 study completed. This
additional revenue generated from a license on our BioChaperone®
technology confirms our business model and will strengthen our
financial situation.”
The Phase 3 clinical program, conducted by Tonghua
Dongbao, involves over 1,500 people with Type 1 and Type 2 Diabetes
in 100 clinical centres across China. The aim of both pivotal
trials is to demonstrate the safety and efficacy of BioChaperone®
Lispro compared to standard of care Humalog® (Eli Lilly). The
primary efficacy endpoint is the change in HbA1c (glycosylated
haemoglobin) from baseline to 26 weeks of treatment, with a
non-inferiority objective. The secondary efficacy endpoints are
1-hour and 2-hour Postprandial Glucose (PPG) excursions at week
26.
BioChaperone® Lispro was licensed to Tonghua Dongbao in
2018, as part of a Licensing Agreement covering China and other
Asian countries1.
This region is experiencing a sharp rise in the prevalence of
diabetes, with nearly 200 million people affected by the disease
and an estimated 20 million people using insulin every day.
Over one in four diabetic patients in the world is in China2.
Tonghua Dongbao is one of the leading insulin providers in Asia,
generating over 70% of its revenues from the insulin market,
highlighting its strategic commitment to the development and
commercialization of BioChaperone® Lispro in China and its
region.
This $10 million milestone payment to Adocia will add up to the
$15 million already received from previous upfront and milestone
payments for BioChaperone® Lispro. The Licensing Agreement also
provides for a further $20 million milestone payment upon granting
of Marketing Authorization, plus double-digit royalties on future
sales.
About BioChaperone® Lispro
BioChaperone® Lispro is an Ultra-Rapid Insulin, belonging to the
latest generation of prandial insulins. It combines Adocia's
proprietary BioChaperone® technology with insulin lispro, the
active ingredient in the standard of care, Humalog® (Eli
Lilly).
This innovative formulation acts significantly faster than
earlier insulin generations, effectively reducing post-meal
hyperglycemia, which is a key contributor to long-term
complications such as retinopathy, diabetic foot ulcers, or kidney
failure. Additionally, its rapid elimination minimizes the risk of
hypoglycemia, often caused when insulin level remains high after
post-meal glucose levels have normalized.
The faster action profile of BioChaperone® Lispro enhances its
compatibility with modern diabetes management systems, particularly
insulin pump systems, and provides better integration into advanced
treatment algorithms.
Beyond its clinical advantages, the quick onset of BioChaperone®
Lispro improves quality of life by offering greater flexibility in
dose timing. Patients can administer insulin at mealtime, or even
right-after-mealtime, allowing for more accurate dosing based on
known meal timing and content. This reduces the risks of overdosing
or underdosing, which can lead to hypo- or hyperglycemia and their
associated complications. The simplified dosing process eases the
psychological burden on patients and caregivers, significantly
alleviating the stress associated with diabetes management.
About Tonghua Dongbao
Tonghua Dongbao Pharmaceutical Co. Ltd (SHSE: 600867), is a
pharmaceutical company based in Jilin province, China, specializing
in the R&D, manufacturing and marketing of insulins and other
diabetes treatments. Tonghua Dongbao currently employs over 3,000
people and has sales of around $400 million. It has been listed on
the Shanghai Stock Exchange since 1994, with a market
capitalization of about $3 billion.
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 different hormones; 2) AdOral®, an oral peptide
delivery technology; 3) AdoShell®, an immunoprotective biomaterial
for cell transplantation, with an initial application in pancreatic
cells transplantation; and 4) AdoGel®, a long-acting drug delivery
platform.
Adocia holds more than 25 patent families. Based in Lyon, the
company has about 80 employees. Adocia is listed on the regulated
market of Euronext™ 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 set forth in the
“Risk Factors” section of the universal registration document that
was filed with the French Autorité des marchés financiers on April
29, 2024, as updated in the Company’s 2024 Half-year financial
statements, published on September 19, 2024, both available at
www.adocia.com. Those risks include uncertainties inherent in
Adocia's short- or medium-term working capital requirements (the
Company's current cash runway being into Q3 2025), in research and
development, future clinical data, analyses and the evolution of
economic conditions, the financial markets and the markets in which
Adocia operates, which could impact the Company's short-term
financing requirements and its ability to raise additional
funds.
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 at this time. The occurrence of all or part
of such risks could cause the actual results, financial conditions,
performances, or achievements of Adocia be materially different
from those mentioned in the forward-looking statements.
___________________________________ 1 Press Release, Apr. 26,
2018: Adocia and Tonghua Dongbao Announce a Strategic Alliance for
BioChaperone Combo and BioChaperone® Lispro in China 2
International Diabetes Federation, 10 Atlas, 2021
View source
version on businesswire.com: https://www.businesswire.com/news/home/20241212572591/en/
Adocia Olivier Soula CEO
contactinvestisseurs@adocia.com +33 (0)4 72 610 610
www.adocia.com
Ulysse Communication Adocia Press & Investor
Relations Bruno Arabian Nicolas Entz
adocia@ulysse-communication.com + 33 (0)6 87 88 47 26
Adocia (EU:ADOC)
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