Date: 2018-02-17
Type of
information: Presentation of results at a congress
phase: 1
Announcement: presentation of results iat the American Academy of Dermatology (AAD) Annual Meeting 2018
Company: Galapagos (Belgium) MorphoSys (Germany)
Product: MOR106
Action
mechanism:
- monoclonal antibody. MOR106 is a human monoclonal antibody designed to selectively target IL-17C. IL-17C has been shown to be distinct from other members of the IL-17 cytokine family and to play an important and pro-inflammatory role in certain skin disorders.
- MOR106 has been shown to potently inhibit the binding of IL-17C to its receptor and thus to inhibit its biological activity. MOR106 arises from a strategic discovery and co-development alliance between Galapagos and MorphoSys, in which both companies contribute their core technologies and expertise. Galapagos provides the disease-related biology including cellular assays and targets discovered using its target discovery platform. MorphoSys contributes its Ylanthia antibody technology to generate fully human antibodies directed against the target and contributes full CMC development of this compound.
Disease: atopic dermatitis
Therapeutic
area: Dermatological diseases
Country: Belgium, Hungary, Republic of Moldova, Romania
Trial
details:
- This is a randomized, double-blind, placebo-controlled, dose-escalation, phase I study for the assessment of safety, tolerability and pharmacokinetics of single ascending doses of MOR106 in healthy male subjects and multiple ascending doses in subjects with moderate to severe atopic dermatitis. (NCT02739009)
Latest
news:
- • On February 17, 2018, Galapagos and MorphoSys announced the presentation of more detailed results of the Phase 1 study with the investigational IL-17C antibody MOR106 in AD patients at the American Academy of Dermatology (AAD) Annual Meeting 2018 in San Diego, CA, USA, held from 16-20 February. Initial study data were reported in September 2017. In the study, MOR106 showed first signs of activity and durable responses and was generally well tolerated in AD patients.
- Professor Diamant Thaçi MD, Director of the Institute for Inflammation Medicine at the University Clinic Schleswig-Holstein Campus Luebeck and Independent Advisor for the study, presented results of the randomized, double-blind, placebo-controlled Phase 1 trial, evaluating single ascending doses (SAD) of MOR106 in healthy volunteers, and multiple ascending doses (MAD) in patients with moderate-to-severe AD in the late breaking abstracts session at AAD 2018. In the MAD part, 25 patients received four infusions once weekly of either MOR106 (at the doses of 1, 3, and 10 mg/kg body weight, respectively) or placebo in a 3:1 ratio. Patients were followed for 10 weeks after the end of the treatment period.
- In the MAD part in AD patients reported at AAD 2018, all adverse drug reactions observed were mild-to-moderate and transient in nature. No serious adverse events (SAEs) and no infusion-related reactions were recorded. MOR106 exhibited a favorable pharmacokinetics profile with dose-dependent exposure.
- At the highest dose level of MOR106 (10mg/kg body weight), in 83% of patients (5 out of 6) an improvement of at least 50% in signs and extent of AD, as measured by EASI-50, was recorded at week 4. The onset of activity occurred within two to four weeks, depending on the dose administered.
- Pooled data across dose cohorts showed that patients treated with MOR106 achieved an EASI improvement compared to baseline of 58%, 62%, 72%, and 64% at week 4, 8, 12, and 14, respectively. For patients receiving placebo, the EASI improvement was 32%, 40%, 38%, and 50%.
- • On September 29, 2016, MorphoSys and Galapagos announced that the first patient with atopic dermatitis was dosed in an ongoing clinical phase 1 study with MOR106 against IL-17C. MOR106 is the first publicly disclosed monoclonal antibody targeting IL-17C in clinical development worldwide. The primary objective of the ongoing randomized, double-blind, placebo-controlled phase 1 study is to evaluate the safety and tolerability. As secondary endpoints, the study will assess pharmacokinetics and potential immunogenicity of MOR106.
- The first part of the study is being conducted as a single center study in 56 healthy volunteers, evaluating single ascending doses (SAD) as intravenous infusion compared to placebo. To date, MOR106 has shown favorable safety and PK results administered to healthy volunteers in the ongoing study. This has triggered the start of the second part of the study investigating multiple ascending doses (MAD) compared to placebo in approximately 24 patients with moderate to severe atopic dermatitis in several European study centers. As previously reported, topline results of the complete study, including the MAD part in patients and further results from the SAD part in healthy volunteers, are expected for the second half of 2017.
Is
general: Yes
