Adocia Announces Positive Clinical Results Confirming the Ultra-Rapid Profile of a BioChaperone Lispro Formulation Containing Insulin from Partner Tonghua Dongbao

Nachrichtenquelle: Business Wire (engl.)
25.01.2021, 18:00  |  200   |   |   

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)).

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Adocia Announces Positive Clinical Results Confirming the Ultra-Rapid Profile of a BioChaperone Lispro Formulation Containing Insulin from 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, …

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