Adocia Initiates BC LisPram Phase 1 Clinical Trial in Pump for People with Type 1 Diabetes
29 Junho 2021 - 1:00PM
Adocia (Euronext Paris: FR0011184241 – ADOC), a clinical stage
biopharmaceutical company focused on diabetes treatment and other
metabolic diseases with innovative formulations of proteins and
peptides, announced today the launch of a Phase 1 clinical study in
collaboration with Dr. Ahmad Haidar, McGill University, Canada, to
assess pharmacokinetic, glycemic control and safety of
BioChaperone® Lispro Pramlintide (BC LisPram) prandial formulation
in 16 people with type 1 diabetes compared to rapid insulin lispro.
“We have demonstrated that lispro and pramlintide
infused by two separate pumps improves glycemic control compared to
lispro alone in an artificial pancreas1 and most of my patients
stated that they would prefer the coformulation if it were
commercially available. So, we are very excited to study BC
LisPram, which allows the use of only one pump to deliver both
hormones,” declared Dr. Ahmad Haidar.
The medical benefits of pramlintide are
scientifically demonstrated. Adding pramlintide to insulin improves
glycemic control after a meal, induces weight loss, and induces a
satiety effect. Pramlintide, despite being the only drug approved
as an adjunct to insulin in type 1 diabetes, is underused as it
requires three additional daily injections in addition to the
multiple injections of insulin.
Adocia has developed two products, M1Pram in pen
for Multiple Daily Injection, currently in Phase 2, and now BC
LisPram for insulin pump delivery. Adocia has confirmed the
attributes of pramlintide in previous clinical trials with
M1Pram.
“We aim to offer the powerful combined effects of
amylin and insulin to people with diabetes without increasing their
burden. We are very glad to conduct this trial with Dr. Ahmad
Haidar who has made a strong contribution by demonstrating the
importance of pramlintide in pump as an adjunct to insulin in
human,” declared Olivier Soula, Deputy CEO and R&D Director of
Adocia.
About BioChaperone® LisPram
BioChaperone® Lispro Pramlintide (BC LisPram) is a
fixed combination of two approved hormones analogs, the insulin
analog lispro and the amylin analog pramlintide. The
BioChaperone® proprietary technology of Adocia stabilizes the
coformulation of lispro and pramlintide, two peptides that are
naturally not stable together in a liquid solution ready for
injection.
About Adocia
Adocia is a clinical-stage biotechnology company
that specializes in the development of innovative formulations of
therapeutic proteins and peptides for the treatment of diabetes and
metabolic diseases. In the diabetes field, Adocia’s portfolio of
injectable treatments is among the largest and most differentiated
of the industry, featuring five clinical-stage products and several
pre-clinical products. The proprietary BioChaperone® technological
platform is designed to enhance the effectiveness and/or safety of
therapeutic proteins while making them easier for patients to use.
Adocia customizes BioChaperone® to each protein for a given
application.
Adocia’s clinical pipeline includes four novel
insulin formulations for prandial treatment of diabetes: two
ultra-rapid formulations of insulin analog lispro (BioChaperone®
Lispro U100 and U200), a combination of basal insulin glargine and
rapid acting insulin lispro (BioChaperone® Combo) and one
combination of a prandial insulin with amylin analog pramlintide
M1Pram. The clinical pipeline also includes an aqueous formulation
of human glucagon (BioChaperone® Glucagon) for the treatment of
hypoglycemia.
Adocia preclinical pipeline includes bi-hormonal
combinations for diabetes treatment: two combinations of rapid
acting insulin analogs and Pramlintide (BioChaperone® Lispro Pram
and BioChaperone® Aspart Pram), a combination of insulin glargine
with GLP-1 receptor agonists (BioChaperone® Glargine Liraglutide).
In addition, there are two bi-hormonal products for the treatment
of obesity: a combination of glucagon and exenatide (BioChaperone®
GluExe) and a combination of pramlintide and exenatide
(PramExe).
Adocia recently added a preclinical program to its
pipeline with a cell therapy initiative focused on development of a
hydrogel scaffold for use in people with type 1 diabetes. The first
patent application supporting this program has been filed.
Contact Adocia
AdociaGérard
SoulaCEOcontactinvestisseurs@adocia.com Ph: +33 4 72
610 610www.adocia.com |
MC Services AGAdocia Press Relations Europe Raimund
GabrielManaging
Partneradocia@mc-services.eu Ph: +49 89 210 228
0 |
The Ruth GroupAdocia Investor Relations USAJames
SaliernoVice-President jsalierno@theruthgroup.com Ph.: +1
646 536 7035 |
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 Universal
Registration Document filed with the French Autorité des marchés
financiers on April 20, 2021 (a copy of which is available at
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.
____________1 A. Haidar et al at McGill University
Diabetes Care. 2020 Mar;43(3):597-606
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