Novartis Advances First-in-Class Anti-IL-17C Monoclonal Antibody MOR106 into Phase II Clinical Trial for Atopic Dermatitis
Apr 24, 2019 16:03
CST Updated
16:03
Novartis
Drug Development and Manufacturing
April 24, 2019 /Bio ValleyBIOON/ -- Swiss pharmaceutical giantNovartisNovartis, together with Belgian biotechnology company Galapagos NV and German biotechnology company MorphoSys AG, recently announced the initiation of the Phase II clinical study GECKO to evaluate the subcutaneous formulation of MOR106 in combination with topical steroids for the treatment of patients with moderate-to-severe atopic dermatitis (AD).
This study will enroll 60 patients in the United States and Canada, aiming to serve as aFDAInitiation of an Investigational New Drug (IND) application-enabled study. Patients will be randomized to receive a single subcutaneous injection of MOR106 or placebo for 8 weeks, concomitant with topical corticosteroid therapy, followed by a 16-week follow-up period. The primary endpoint is the incidence of adverse events and serious adverse events occurring through Day 169 of treatment. Pharmacokinetics (PK) of subcutaneously administered MOR106 and the development of anti-drug antibodies will serve as secondary endpoints. Additionally, the efficacy of MOR106 will be explored.
Dr. Piet Wigerinck, Chief Scientific Officer of Galapagos, stated, “In the GECKO study, our aim is to explore the efficacy of MOR106 in combination with topical corticosteroids, the most commonly prescribed treatment for atopic dermatitis. This investigator-initiated trial expands the development program for MOR106 to the United States and Canada, complementing the ongoing clinical evaluations in Europe.”
Dr. Malte Peters, Chief Development Officer at Morphosys AG, stated, “Moderate-to-severe atopic dermatitis is a chronic, debilitating disease that affects millions of patients worldwide. We clearly see that the unmet medical need for additional treatment options remains.” According toNovartisglobal license agreement, we have now jointly initiated this IND-enabling Phase II study with our partner Galapagos, and we look forward to further expanding the development program of MOR106 for the treatment of moderate-to-severe atopic dermatitis.”
On September 10, 2018, an exclusive licensing agreement worth up to $1.11 billion between Novartis and Galapagos NV and MorphoSys AG for the experimental anti-inflammatory drug MOR106 came into effect. Under the agreement, Novartis obtained exclusive global development and commercialization rights for MOR106 in the treatment of atopic dermatitis and all other potential indications.NovartisAn upfront payment of €950 million (approximately $111 million) will be made to Galapagos NV and MorphoSys AG, with additional milestone payments totaling up to €850 million (approximately $1 billion) payable upon achievement of agreed-upon milestones, as well as double-digit royalty rates (ranging from the teens to the twenties percent) on post-launch sales.
MOR106 is a monoclonal antibody drug that targets and binds to interleukin-17C (IL-17C). IL-17C is a novel target that is upregulated in inflammatory skin diseases such as psoriasis and atopic dermatitis. Preclinical model findings indicate that IL-17C plays a significant pro-inflammatory role in these dermatological conditions. Importantly, IL-17C has been shown to differ biologically from other members of the IL-17 cytokine family, as it is produced by distinct cell types, primarily epithelial cells. Results from rodent models of inflammatory skin disease support the clinical development of MOR106. The binding of IL-17C to its receptor, composed of the subunits IL-17RA and IL-17RE, is believed to trigger an inflammatory cascade that contributes to the pathogenesis of inflammatory skin diseases. By specifically binding to IL-17C, MOR106 aims to block the interaction between IL-17C and its receptor, thereby neutralizing the biological activity of IL-17C.
MOR106 is an extension of Novartis’ Alzheimer’s disease (AD) pipeline assets. The company currently has one oral drug, ZPL389, in Phase II clinical trials for the treatment of AD. In a double-blind, placebo-controlled Phase Ib study, MOR106 demonstrated preliminary signs of efficacy and exhibited a favorable safety and tolerability profile. MOR106 has the potential to become a first-in-class anti-IL-17C monoclonal antibody for the treatment of AD and other inflammatory diseases. The in-licensing of MOR106 underscores Novartis’ commitment to immuno-dermatology. Currently,NovartisTwo dermatology products have already been launched: Cosentyx (secukinumab, an anti-IL-17A monoclonal antibody) and Xolair (omalizumab, an anti-IgE monoclonal antibody).
Atopic Dermatitis (AD) is a specific subtype of eczema, a severe chronic inflammatory skin disease characterized primarily by intense pruritus, prominent eczematous changes, and xerosis. The disease often onset in infancy and childhood, with some patients affected throughout their lifetime. It can significantly impair patients' quality of life due to chronic relapsing eczematous rashes, severe pruritus, sleep deprivation, dietary restrictions, and psychosocial impacts. AD affects approximately 8% of adults and 14% of children worldwide, indicating a significant unmet medical need for innovative therapies in this field. (Bioon.com)