Inno8 / Novo Nordisk - LARVOL DELTA

Mim8 improves the In Vivo hemostasis of select hemophilia B causing factor IX variants (ASH 2025) - "Mim8 (denecimig) is a next-generation FVIIIa-mimetic with distinct binding epitopes and increased potency compared toemicizumab; it is in late-stage clinical development for HA. This clot size approaches the clot size inour previous studies of wild-type mice (platelets 400 ± 40 µm2 and fibrin 280 ± 40 µm2).ConclusionMim8 improves the in vitro and in vivo hemostatic activity of select HB-causing FIX variants. Themagnitude of this improvement for some variants—such as R333Q and I397T, which account for 5.7% ofpeople with HB—is likely therapeutically relevant."

Preclinical • Hematological Disorders • Hemophilia • Hemophilia A • Hemophilia B • Rare Diseases • EGF

VOYAGER2: A Research Study Looking at How Different Doses of Study Medicine (Inno8) Work in the Body of People With Haemophilia A (clinicaltrials.gov) - P1 | N=20 | Recruiting | Sponsor: Novo Nordisk A/S | Not yet recruiting ➔ Recruiting | Trial completion date: May 2026 ➔ Dec 2026 | Trial primary completion date: May 2026 ➔ Dec 2026

Enrollment open • Trial completion date • Trial primary completion date • Hematological Disorders • Hemophilia • Hemophilia A • Rare Diseases

A Research Study Looking at How Food Intake Affects Inno8 in the Body of Healthy People (clinicaltrials.gov) - P1 | N=80 | Not yet recruiting | Sponsor: Novo Nordisk A/S

New P1 trial • Hematological Disorders • Hemophilia • Hemophilia A • Rare Diseases

FVIII Inhibitors can Accurately be Measured in the Presence of Mim8 in Hemophilia A Plasma (ASH 2023) - "Using aPTT-based Modified Nijmegen-Bethesda Assays in the presence of FVIIIa Mimetics such as Mim8 is not recommended due to interference. This study showed that by using FVIII chromogenic assays containing bovine reagents, FVIII inhibitors levels up to at least ⁓5. 0 BU/mL can be accurately determined in severe hemophilia A plasma in the presence of up to 40 µg/mL Mim8."

Hematological Disorders • Hemophilia • Hemophilia A • Rare Diseases

VOYAGER2: A Research Study Looking at How Different Doses of Study Medicine (Inno8) Work in the Body of People With Haemophilia A (clinicaltrials.gov) - P1 | N=20 | Not yet recruiting | Sponsor: Novo Nordisk A/S

New P1 trial • Hematological Disorders • Hemophilia • Hemophilia A • Rare Diseases

VOYAGER1: A Study Looking at How Different Doses of Study Medicine (Inno8) Works in the Body of Healthy Men (clinicaltrials.gov) - P1 | N=108 | Recruiting | Sponsor: Novo Nordisk A/S | Trial completion date: Sep 2025 ➔ May 2026 | Trial primary completion date: Jun 2025 ➔ May 2026

Trial completion date • Trial primary completion date • Hematological Disorders • Hemophilia • Hemophilia A • Rare Diseases

In vitro effects of Mim8 and combined Mim8-bypassing therapy on thrombin generation, thromboelastography and fibrin clot ultrastructure. (PubMed, Thromb Res) - "Mim8 significantly improves TG in vitro in both PPP and PRP from patients with severe HA, with ETP levels comparable to those of FVIII at 100 IU/dL. The TGA can effectively monitor the combined treatment with Mim8 and either rFVIIa or APCC, which is not possible with currently available routine laboratory tests."

Journal • Preclinical • Hematological Disorders • Hemophilia • Hemophilia A • Rare Diseases

VOYAGER1: A Study Looking at How Different Doses of Study Medicine (Inno8) Works in the Body of Healthy Men (clinicaltrials.gov) - P1 | N=92 | Recruiting | Sponsor: Novo Nordisk A/S

New P1 trial • Hematological Disorders • Hemophilia • Hemophilia A • Rare Diseases