fletikumab (NNC109-0012) / Novo Nordisk - LARVOL DELTA

NNC0109-0012 (anti-IL-20 mAb), well tolerated in healthy subjects and patients with rheumatoid arthritis (EULAR 2012) - P1, N=32; Linear PK in the dose range 0.05-3.00 mg/kg was indicated in both healthy subjects and patients with RA; No statistically significant difference was observed in the single-dose PK properties of NNC0109-0012 between healthy subjects and patients with RA

P1 data • Immunology • Rheumatoid Arthritis

First-In-Human, Phase 1, Randomized, Dose-Escalation Trial with Recombinant Anti-IL-20 Monoclonal Antibody in Patients with Psoriasis. (PubMed) - "Single and multiple doses of NNC0109-0012, ranging from 0.05 to 3.0 mg/kg, were well tolerated in patients with psoriasis and exhibited pharmacokinetics similar to that of other monoclonal antibodies."

Journal • Biosimilar • Immunology • Inflammation • Psoriasis

Comparison of electrocardiogram characteristics between left bundle branch pacing and right ventricular septal pacing in patients receiving pacemaker therapy (ESC 2018) - "...Left bundle brunch potential was frequently observed prior to the beginning of QRS complex in intracardiac electrograms during intrinsic rhythm in LBBP group but not in RVSP group.In the LBBP group, ECG QRS duration was 109.0012.51 ms during pacing and 110.0039.57 ms during intrinsic rhythm (P=0.931)... This study demonstrates better ECG characteristics during LBBP at the basal ventricular septum compared to that during conventional RVSP, raising the possibility of using LBBP as a candidate for ventricular pacing."

Clinical • Biosimilar • Cardiovascular

Efficacy and safety of NNC0109-0012 (ANTI-IL-20 MAB) in patients with rheumatoid arthritis: Results from a phase 2A trial (EULAR 2012) - Presentation time: 08.06.2012; 16:15; Anticipated presentation at EULAR 2012

Anticipated P2a results • Immunology

Efficacy and safety of NNC0109-0012 (anti-IL-20 mAb) in patients with rheumatoid arthritis: results from a phase 2a trial (EULAR 2012) - P2a, N=67; At 12 weeks, mean changes in DAS28-CRP were significantly greater for NNC0109-0012 compared to placebo (-0.88; p=0.020); Significant reduction of disease activity (-0.5; p=0.011) was observed already after 1 week of treatment and maintained for 5 weeks after end of treatment

P2 data • Immunology • Rheumatoid Arthritis

Improvements in patient-reported pain and global disease activity in rheumatoid arthritis patients after treatment with NNC0109- 0012 (Anti-IL-20 mAb) in a phase 2a trial (ISPOR Eu 2012) - P2a, N=67; "The average baseline pain and disease activity were 67 and 68 mm (NNC0109-0012) and 71 and 70 mm (placebo). In all randomised patients, pain was significantly reduced for NNC0109-0012 compared to placebo after 12 weeks with a mean difference of -15 mm (p=0.034) and was -13 mm (p=0.046) at week 25"

P2a data • Immunology • Rheumatoid Arthritis

Clinical responses and patient reported outcomes to NNC0109-0012 (anti-IL-20 mAb) in rheumatoid arthritis (RA) patients following 12-weeks dosing and 13 weeks follow up: Results from a phase 2a trial (ACR/ARHP 2012) - Presentation time: Sunday, November 11; 5:45 PM; P2, N=67; NCT01282255; DAS28 was significantly decreased vs. PBO at Weeks 12 & 16, and through Weeks 12 - 25 for seropositive (RF and anti-CCP positive) pts (n=29 and 14; 3mg/kg & PBO, respectively); Significantly more NNC0109-0012 treated seropositive pts vs. PBO achieved ACR20/50 at Wk 12 & ACR70 at Wks 12, 16 & 20

P2 data • Immunology • Rheumatoid Arthritis

The IL-20 Cytokine Family in Rheumatoid Arthritis and Spondyloarthritis. (PubMed, Front Immunol) - "Clinical trials that investigate inhibitors of IL-20 (fletikumab) and IL-22 (fezakinumab) in psoriasis and RA have been terminated. All IL-20 family members utilize the Janus kinase signaling pathway and are therefore potentially inhibited by drugs targeting these enzymes. Effects and adverse effects in ongoing clinical trials with inhibitors of IL-22 and the IL-22RA1 subunit and recombinant IL-22 fusion proteins will possibly provide important information about the IL-20 subfamily of cytokines in the future."

Journal • Review