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Mim8, a novel factor VIIIa mimetic bispecific antibody, shows favorable safety and pharmacokinetics in healthy adults.
Persson, Paula; Amstrup, Anne-Beth; Coester, Hans Veit; Matytsina, Irina; Bas, Selcuk.
Afiliação
  • Persson P; Novo Nordisk A/S, Søborg, Denmark.
  • Amstrup AB; Novo Nordisk A/S, Søborg, Denmark.
  • Coester HV; Profil Institut für Stoffwechselforschung GmbH, Neuss, Germany.
  • Matytsina I; Novo Nordisk A/S, Søborg, Denmark.
  • Bas S; Charité Research Organization, Campus Charité Mitte, Berlin, Germany.
Res Pract Thromb Haemost ; 7(6): 102181, 2023 Aug.
Article em En | MEDLINE | ID: mdl-37745159
ABSTRACT

Background:

Mim8 (denecimig) is a novel activated coagulation factor VIII-mimetic bispecific antibody that assembles with activated coagulation FIX and FX on the platelet membrane surface.

Objectives:

The FRONTIER1 (NCT04204408, NN7769-4513) single ascending dose and the 4882 pharmacokinetic (PK) studies (NCT05127473, NN7769-4882) examined the safety, tolerability, PK, and pharmacodynamics (PD) of Mim8 in healthy adult males.

Methods:

The FRONTIER1 single ascending dose study consisted of 6 cohorts, each with 6 participants who received a single subcutaneous (s.c.) dose of Mim8 and 2 participants who received a placebo. The 4882 PK study had 11 arms, each with 6 participants who received a single s.c. dose of Mim8. The primary endpoint for both studies was treatment-emergent adverse events. Other safety assessments included relative changes in D-dimer, prothrombin fragments 1 and 2, fibrinogen, and platelets. The PK and PD were assessed using Mim8 plasma concentration and activated partial thromboplastin clotting time and thrombin generation, respectively.

Results:

Mim8 was well tolerated, and there were no severe treatment-emergent adverse events. The PK properties of Mim8 in both studies were consistent with dose-proportionality. The terminal half-life of Mim8 after a single dose was approximately 1 month, and maximum plasma concentration was reached after 10 days.

Conclusion:

The PK and PD profiles suggest that Mim8 is suitable as a long-acting FVIIIa-mimetic bispecific antibody for hemophilia A prophylaxis.
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Texto completo: 1 Base de dados: MEDLINE Idioma: En Ano de publicação: 2023 Tipo de documento: Article

Texto completo: 1 Base de dados: MEDLINE Idioma: En Ano de publicação: 2023 Tipo de documento: Article