Adocia Announces Positive Clinical Results Confirming the Ultra-Rapid Profile of a BioChaperone® Lispro Formulation Containi...
January 25 2021 - 12:00PM
Business Wire
- In this study, the BioChaperone Lispro formulation containing
insulin lispro from Tonghua Dongbao demonstrated similar
ultra-rapid pharmacokinetic, pharmacodynamic, and safety profiles
when compared to a BioChaperone Lispro formulation containing
insulin lispro Humalog®
- In nine previous studies, a BC Lispro formulation using insulin
lispro (Humalog®) demonstrated an Ultra-Rapid profile which
significantly improved glycemic control compared to Humalog®,
Novolog®and Fiasp®
- Results from this study complete the dossier for BioChaperone
Lispro, employing insulin lispro from Tonghua Dongbao, required for
initiation of Phase 3 studies in China, Europe, and the US
- This study confirms the performance of the insulin lispro drug
substance supplied by our strategic partner, Tonghua Dongbao
Regulatory News:
Adocia (Paris:ADOC) (Euronext Paris: FR0011184241 – ADOC, the
“Company”), the biopharmaceutical company focused on the treatment
of diabetes and other metabolic diseases with innovative
formulations of proteins and peptides, announced today positive
results from a clinical pharmacology study comparing BioChaperone
(BC) Lispro formulations employing insulin lispro from two
different sources, a biosimilar from Tonghua Dongbao (THDB) and the
brand, Humalog®, from Eli Lilly.
“We are pleased with the clinical results Adocia has obtained
using our insulin lispro. These results are quite valuable for both
companies, as they may serve to advance the launch of Phase 3
studies of BC Lispro in 2021 in China”, comments Dr Chunsheng Leng,
the Tonghua Dongbao CEO.
This randomized, cross-over, double-blind, euglycemic clamp
study was conducted on 30 people with type 1 diabetes. The study
aimed to assess and compare the pharmacodynamic and pharmacokinetic
properties as well as the safety of the four following
formulations:
- BC Lispro (Adocia) composed of BioChaperone® and Tonghua
Dongbao ’s insulin lispro
- BC Lispro (Adocia) composed of BioChaperone® and the insulin
lispro, Humalog®
- Humalog® (Eli Lilly) approved in the USA
- Humalog® (Eli Lilly) approved in Europe
The BC Lispro (THDB) formulation demonstrated similar
pharmacodynamic and pharmacokinetic properties to BC Lispro
formulated with Humalog®, the formulation previously assessed in
nine clinical trials.
Specifically, the BC Lispro (THDB) formulation demonstrated a
significantly faster absorption profile than the two commercial
formulations of Humalog® (insulin lispro exposure over the first
hour after injection AUCLispro_0-1h : 550 pmol*h/L for BC Lispro
(THDB), 379 pmol*h/L for Humalog® Europe (p<0.0001 v BC Lispro
(THDB)) and 366 pmol*h/L for Humalog US (p<0.0001 vs BC Lispro
(THDB)); and a faster-on effect (area under the glucose infusion
rate curve for the first hour AUCGIR_0-1h : 200 mg/kg for BC Lispro
(THDB) ; 95 mg/kg for Humalog® Europe (p=0.0027) and 83 mg/kg for
Humalog® US (p=0.0002)).
Conversely, BC Lispro (THDB) displayed fast-out/fast-off
characteristics since the late exposure and late effect of BC
Lispro (THDB) are lower than those of both Humalog formulations
(insulin lispro exposure over 2-6h post-dosing AUCLispro_2-6h: 802
pmol*h/L for BC Lispro (THDB), 953 pmol*h/L for EU-Humalog
(p<0.0001 vs BC Lispro (THDB)) and 1014 pmol*h/L for US-Humalog
(p<0.0001 vs BC Lispro (THDB); area under the glucose infusion
rate curve over 4-8h post-dosing AUCGIR_4-8h : 175 mg/kg for BC
Lispro (THDB), 268 mg/kg for EU-Humalog (p=0.0003 vs BC Lispro
(THDB)) and 277 mg/kg for US-Humalog (p=0.0001 vs BC Lispro
THDB)).
All four interventions were safe and well tolerated.
These results confirm the ultra-rapid insulin action profile of
BC Lispro, and a safety profile similar to that of Humalog®. This
study was approved by the German Health Authority on the 24th of
July 2020, as well as by the FDA on the 29th of July 2020 as part
of an IND study.
“This is a very important step for Adocia as we now feature a
product ready for Phase 3 studies worldwide. Moreover, it is a
product supported by a global supply agreement for high quality
lispro drug substance from our partner Tonghua Dongbao. Our
priority remains to find a partner to lead the Phase 3 program for
Europe and the United States", comments Olivier Soula, the Deputy
CEO and Director of R&D at Adocia.
About BioChaperone®
Lispro
BioChaperone® Lispro (BC Lispro) is an ultra-rapid prandial
insulin formulation containing insulin lispro and the proprietary
technology BioChaperone®. The BioChaperone® excipient ensures a
faster absorption of insulin. BC Lispro has demonstrated a faster
action profile compared to insulin analog lispro (Humalog®, Eli
Lilly) and insulin analog aspart (Novolog®, Novo Nordisk), in nine
Phase 1/2 studies in people with type 1 and type 2 diabetes,
administered either by syringes or insulin pumps. Also, BC Lispro
significantly improved insulin performance compared to Humalog® in
six clinical studies.
In 2018, Adocia and partner Tonghua Dongbao (China) signed a
strategic alliance to develop and commercialize BC Lispro in China
and in other Asian and Middle East territories. Tonghua Dongbao
also supplies insulin lispro and insulin glargine to Adocia for the
entire world (except China). This supply allows Adocia to progress
its own BC Lispro and BC Combo programs and expand its partnership
opportunities. Adocia retains development rights for BC Lispro in
the US, Europe, Japan and Latin America. BC Lispro is ready for
out-licensing in these key territories.
For more information on BC Lispro, visit our website:
https://www.adocia.com/products/biochaperone-ultra-fast-analog-insulin/
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 four clinical-stage 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 (ADO09). The
clinical pipeline also includes an aqueous formulation of human
glucagon (BioChaperone® Glucagon) for the treatment of
hypoglycemia.
Adocia preclinical pipeline includes three products: a
combination of rapid human insulin analogues and Pramlintide
(BioChaperone LisPram), a combination of insulin glargine with
GLP-1 receptor agonists (BioChaperone® Glargine GLP-1) for the
treatment of diabetes and a ready-to-use combination of glucagon
and a GLP-1 receptor agonist (BioChaperone® Glucagon GLP1) for the
treatment of obesity.
Adocia recently added a fourth program, a preclinical stage 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.
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 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 22, 2020
(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.
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version on businesswire.com: https://www.businesswire.com/news/home/20210125005622/en/
Adocia Gérard Soula CEO contactinvestisseurs@adocia.com Tel :
+33 4 72 610 610 www.adocia.com
MC Services AG Adocia Press Relations Europe Raimund Gabriel
Managing Partner adocia@mc-services.eu Ph: +49 89 210 228 0
The Ruth Group Adocia Investor Relations USA James Salierno
Vice-President jsalierno@theruthgroup.com Ph.: +1 646 536 7035
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