NN9828 / Novo Nordisk, Almirall - LARVOL DELTA

Almirall Licenses an Anti-IL-21 Monoclonal Antibody From Novo Nordisk to Develop It as a First-in-Class Agent in Dermatology (Businesswire) - "Almirall S.A...announced today that it has entered into an exclusive license agreement with Novo Nordisk for rights to the IL-21 blocking monoclonal antibody NN-8828. Under the agreement, Almirall obtains global rights to develop and commercialize this monoclonal antibody in certain fields, including immune inflammatory dermatological diseases....Almirall will accelerate the development of the asset to address key dermatological diseases taking responsibility for the global development and future commercialization in these indications. Novo Nordisk will receive an upfront payment as well as additional development and commercial milestone payments and tiered royalties based upon future global sales."

Licensing / partnership • Crohn's disease • Immunology • Inflammatory Bowel Disease • Rheumatoid Arthritis

A Clinical Proof-of-principle Trial in Adult Subjects With Newly Diagnosed Type 1 Diabetes Mellitus Investigating the Effect of NNC0114-0006 and Liraglutide on Preservation of Beta-cell Function (clinicaltrials.gov) - P2; N=304; Active, not recruiting; Sponsor: Novo Nordisk A/S; Trial primary completion date: Nov 2018 ➔ Mar 2019

Clinical • Trial primary completion date • Biosimilar • Diabetes • Metabolic Disorders

A randomised, double-blind, placebo-controlled, parallel-group trial to assess clinical efficacy of NNC0114-0006 in subjects with active rheumatoid arthritis (clinicaltrials.gov) - P2, N=60; Sponsor: Novo Nordisk; Recruiting->Active, not recruiting.

Enrollment closed • Rheumatoid Arthritis

An Investigation of Safety and Tolerability of NNC0114-0006 in Subjects With Systemic Lupus Erythematosus (SLE) (clinicaltrials.gov) - P1; N=10; Terminated; Sponsor: Novo Nordisk A/S; Completed -> Terminated

Trial termination • Biosimilar • Immunology • Lupus • Reperfusion Injury

First in human study with recombinant anti-IL-21 monoclonal antibody in healthy subjects and patients with rheumatoid arthritis (ACR/ARHP 2012) - P1, N=64; NCT01208506; NNC0114-0005 was safe and well tolerated in healthy subjects & RA pts; Linear PK of NNC0114-0005 was demonstrated in healthy subjects & pts with RA; PK properties were similar for both populations; Reduction in DAS28-CRP was numerically favorable but not statistically significant for pts with RA treated with 25 mg/kg NNC0114-0005 vs. PBO

P1 data • Rheumatoid Arthritis

Efficacy and safety of NNC01140006, an anti-IL-21 monoclonal antibody, in patients with active rheumatoid arthritis (ACR-ARHP 2014) - Presentation time: Sunday, November 16, 2014, 4:30 PM–6:00 PM; Abstract #947; P2, N=62; NCT01647451; Sponsor: NovoNordisk; “The reduction in DAS28-CRP at week 12 was supported by improved disease activity in terms of ACR20/50/70 and EULAR response, although these endpoints did not reach statistical significance. An expected increase in total (both free and antibody-bound) IL-21 levels after treatment with NNC0114-0006 was observed.”

P2 data • Rheumatoid Arthritis

A Clinical Proof-of-principle Trial in Adult Subjects With Newly Diagnosed Type 1 Diabetes Mellitus Investigating the Effect of NNC0114-0006 and Liraglutide on Preservation of Beta-cell Function (clinicaltrials.gov) - P2; N=308; Completed; Sponsor: Novo Nordisk A/S; Active, not recruiting ➔ Completed; Trial primary completion date: Mar 2019 ➔ Aug 2018

Clinical • Trial completion • Trial primary completion date