MOR106 / Galapagos, Novartis - LARVOL DELTA

MOR106 alleviates inflammation in mice with atopic dermatitis by blocking the JAK2/STAT3 signaling pathway and inhibiting IL-17C-mediated Tfh cell differentiation (PubMed, Xi Bao Yu Fen Zi Mian Yi Xue Za Zhi) - "Compared with AD group, the levels of p-JAK2 and p-STAT3 protein in low-dose and high-dose MOR106 treatment groups decreased significantly. Conclusion MOR106 can reduce the inflammatory response of AD mice by blocking JAK2/STAT3 signaling pathway and inhibiting the differentiation of Tfh cells mediated by IL-17C."

Journal • Preclinical • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Inflammation • ABCB1 • IFNG • IL17A • IL17C

Phase 1 and 2 Randomized Clinical Studies Determine Lack of Efficacy for Anti-IL-17C Antibody MOR106 in Moderate-Severe Atopic Dermatitis. (PubMed, J Clin Med) - P1, P2 | "Cumulatively, MOR106 demonstrated ineffectiveness for the treatment of AD, but its safety and pharmacokinetic characteristics warrant further drug development in other indications. Funding: sponsored by Galapagos NV; funded by Novartis AG."

Journal • P1 data • Atopic Dermatitis • Dermatitis • Dermatology • Dermatopathology • Immunology • Inflammation • IL17A

Galapagos reports H1 financial results with refocused pipeline and operational progress (GlobeNewswire) - "Our R&D expenditure in the first six months of 2021 amounted to €268.8 million, compared to €262.9 million for the first six months of 2020. This increase, primarily related to our filgotinib program and our Toledo program, was compensated by a decrease for ziritaxestat, the osteoarthritis (OA) program with GLPG1972, and the program in atopic dermatitis (AtD) with MOR106....We also expect additional reimbursement decisions for filgotinib in RA across a number of European countries. We are on track to complete the transition from our collaboration partner Gilead to us of the full European commercial operations for filgotinib by year-end, and we anticipate reporting on our own European sales of filgotinib starting in the second half of the year. Completion of the recruitment in the global DIVERSITY Phase 3 trial with filgotinib in Crohn’s disease by our collaboration partner Gilead is also expected later this year."

Commercial • Enrollment status • Reimbursement • Atopic Dermatitis • Crohn's disease • Dermatology • Immunology • Inflammatory Bowel Disease • Rheumatoid Arthritis • Ulcerative Colitis

MOR106: Expiry of patent related to composition-of-matter in February 2037 (Morphosys) - Annual Report 2020

Patent • Atopic Dermatitis • Dermatology

Galapagos reports first quarter 2018 results (GlobeNewswire) - "Galapagos expect to…initiate Phase 2 studies with…MOR106 (atopic dermatitis) later in 2018.”

New P2 trial • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Inflammation

"MorphoSys and @Galapagos announced global license agreement for MOR106 with @Novartis https://t.co/o83q1xOdES $MPSYF" (@MorphoSys)

Clinical

First in Human of Single and Multiple Doses of MOR106 (clinicaltrials.gov) - P1; N=81; Completed; Sponsor: Galapagos NV; Active, not recruiting ➔ Completed

Trial completion • Atopic Dermatitis • Biosimilar • Dermatitis • Eczema • Immunology • Inflammation

A Study to Assess Efficacy, Safety, Tolerability and PK/PD of MOR106 in Subjects With Moderate to Severe Atopic Dermatitis (clinicaltrials.gov) - P2; N=180; Recruiting; Sponsor: Galapagos NV

New P2 trial • Atopic Dermatitis • Biosimilar • Dermatitis • Dermatology • Immunology • Inflammation

Galapagos and MorphoSys report first promising signs of clinical activity in a phase 1 study with IL-17C antibody MOR106 in atopic dermatitis patients (GlobeNewswire) - P1, N=24; NCT02739009; Sponsor: Galapagos and MorphoSys; "Galapagos and MorphoSys AG today announced Phase 1 results with their joint investigational antibody program MOR106 directed against IL-17C in patients with moderate-to-severe atopic dermatitis (AD)...Galapagos and MorphoSys intend to present the clinical data from this study with MOR106 at a future medical conference."

P1 data • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Inflammation

MOR106: "MOR106 shown the first signs of clinical activity: improvement of EASI-50 at week four occurred in 83% of patients (five out of six) at the highest dose level, long-lasting effect" (Morphosys, UBS Global Healthcare Conference)

P1 data • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Inflammation

MOR106: "MOR106 shown the first signs of clinical activity: improvement of EASI-50 at week four occurred in 83% of patients (five out of six) at the highest dose level, long-lasting effect" (Morphosys, UBS Global Healthcare Conference)

P1 data • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Inflammation

MorphoSys presents results for fiscal year 2017 (Morphosys Press Release) - "...plan to start a phase 2 study of MOR106 in patients with atopic dermatitis together with our partner Galapagos in the second quarter of 2018."

New P2 trial • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Inflammation

Galapagos and MorphoSys announce initiation of the IGUANA phase 2 clinical trial with MOR106 in atopic dermatitis patients (GlobeNewswire) - "Galapagos...and MorphoSys...announced today that the first patient has been screened in IGUANA, a Phase 2 study with MOR106, an investigational antibody directed against IL-17C, in atopic dermatitis patients."

Trial initiation date • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Inflammation

MOR106: Expiry of composition-of-matter patent in February 2037 (Morphosys) - Annual Report 2019

Patent

MOR106: Expiry of patents related to composition-of-matter and method of treatment in US/ex-US, EU, Australia and Canada in 2037 (Galapagos) - Annual Report 2019: Expiry of patents related to method of treatment for atopic dermatitis in 2038; Expiry of patents related to formulation and method of treatment for additional indications in 2039

Patent

A Study to Assess Efficacy, Safety, Tolerability and Pharmacokinetics (PK)/Pharmacodynamics (PD) of MOR106 in Subjects With Moderate to Severe Atopic Dermatitis (clinicaltrials.gov) - P2; N=207; Terminated; Sponsor: Galapagos NV; Active, not recruiting ➔ Terminated; MOR106 clinical development in atopic dermatitis was stopped for futility

Clinical • Trial termination

GECKO: A Study to Test Safety and Tolerability of a Study Drug Called MOR106 Administered Concomitantly With Topical Corticosteroids, in Adult Patients With Moderate to Severe Atopic Dermatitis (clinicaltrials.gov) - P2; N=33; Terminated; Sponsor: Galapagos NV; N=60 ➔ 33; Active, not recruiting ➔ Terminated; MOR106 clinical development in atopic dermatitis was stopped for futility

Clinical • Enrollment change • Trial termination

A Study to Test Safety, Tolerability, and the Way the Body Absorbs, Distributes, and Gets Rid of a Study Drug Called MOR106, in Healthy Subjects and in Patients With Moderate to Severe Atopic Dermatitis (clinicaltrials.gov) - P1; N=44; Terminated; Sponsor: Galapagos NV; N=122 ➔ 44; Active, not recruiting ➔ Terminated; MOR106 clinical development in atopic dermatitis was stopped for futility

Clinical • Enrollment change • Trial termination

A Study to Assess Efficacy, Safety, Tolerability and Pharmacokinetics (PK)/Pharmacodynamics (PD) of MOR106 in Subjects With Moderate to Severe Atopic Dermatitis (clinicaltrials.gov) - P2; N=207; Active, not recruiting; Sponsor: Galapagos NV; Trial primary completion date: Nov 2019 ➔ Mar 2020

Clinical • Trial primary completion date

IL-17C amplifies epithelial inflammation in human psoriasis and atopic eczema. (PubMed, J Eur Acad Dermatol Venereol) - "IL-17C amplifies epithelial inflammation in Th2 and Th17 dominated skin inflammation and represents a promising target for the treatment of ISD."

Journal • CCL5 • CXCL10 • CXCL8 • VEGFA

A Study to Test Safety, Tolerability, and the Way the Body Absorbs, Distributes, and Gets Rid of a Study Drug Called MOR106, in Healthy Subjects and in Patients With Moderate to Severe Atopic Dermatitis (clinicaltrials.gov) - P1; N=122; Active, not recruiting; Sponsor: Galapagos NV; Recruiting ➔ Active, not recruiting; Trial completion date: Dec 2020 ➔ Mar 2020

Enrollment closed • Trial completion date

GECKO: A Study to Test Safety and Tolerability of a Study Drug Called MOR106 Administered Concomitantly With Topical Corticosteroids, in Adult Patients With Moderate to Severe Atopic Dermatitis (clinicaltrials.gov) - P2; N=60; Active, not recruiting; Sponsor: Galapagos NV; Recruiting ➔ Active, not recruiting; Trial completion date: Jun 2020 ➔ Mar 2020

Enrollment closed • Trial completion date

A Study to Assess Efficacy, Safety, Tolerability and Pharmacokinetics (PK)/Pharmacodynamics (PD) of MOR106 in Subjects With Moderate to Severe Atopic Dermatitis (clinicaltrials.gov) - P2; N=240; Active, not recruiting; Sponsor: Galapagos NV; Recruiting ➔ Active, not recruiting; Trial completion date: Jun 2020 ➔ Mar 2020

Enrollment closed • Trial completion date

MorphoSys AG: MOR106 clinical development in atopic dermatitis stopped (Morphosys Press Release) - P2, N=240; IGUANA (NCT03568071); Sponsor: Galapagos NV; "MorphoSys...and Galapagos NV...today announced the end of the clinical development program of MOR106 in atopic dermatitis. The joint decision of all three involved parties, Galapagos NV, MorphoSys AG and Novartis Pharma AG, was based on an interim analysis for futility that was performed in the Phase 2 IGUANA trial. The analysis detected a low probability to meet the primary endpoint of the study, defined as the percentage change in the eczema area and severity index (EASI) score. The decision was based on a lack of efficacy and not on safety concerns."

Discontinued • P2 data

Product discontinued (PMLive) - Atopic Dermatitis