17.02.2018 10:00:01
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DGAP-News: MorphoSys AG
DGAP-News: MorphoSys AG / Key word(s): Study results/Conference Planegg/Munich, Germany and Mechelen, Belgium; February 17, 2018 MorphoSys and Galapagos Present Results from a Phase 1 Study with MOR106 in Atopic Dermatitis as Late-Breaking Abstract at the American Academy of Dermatology (AAD) Meeting in San Diego - In the study, MOR106 was generally well tolerated in atopic dermatitis (AD) patients - 83% of patients (5 out of 6) at the highest dose reached at least 50% improvement per the atopic dermatitis area and severity index (EASI-50) at week 4 - Pooled data across all dose cohorts showed 72% improvement of AD symptoms at week 12 compared to baseline in patients treated with MOR106 - Phase 2 development of MOR106 planned to be initiated in first half of 2018 MorphoSys AG (FSE: MOR; Prime Standard Segment, TecDAX; OTC: MPSYY) and Galapagos NV (Euronext & NASDAQ: GLPG) 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. "Moderate-to-severe AD is a chronic, debilitating disease affecting millions of patients worldwide with a clear unmet medical need for safe and efficacious treatments," said Professor Diamant Thaçi MD. "The first signs of clinical activity and the sustained response lasting up to two months after treatment discontinuation support further clinical development of MOR106." 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 all 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%, respectively. MOR106 was generated using MorphoSys's Ylanthia antibody platform and is based on a target discovered by Galapagos. IL-17C is a cytokine which has been related to dermal inflammation and has been shown to be distinct from other members of the IL-17 cytokine family. MOR106 is the first publicly known human monoclonal antibody against IL-17C in clinical development worldwide. MOR106 is an investigational drug and its safety and efficacy are yet to be established. It is expected that Phase 2 development with MOR106 will be initiated in the first half of 2018. Details of the oral presentation on MOR106 at AAD 2018: About Atopic Dermatitis About IL-17C About MOR106 and the antibody collaboration HuCAL(R), HuCAL GOLD(R), HuCAL PLATINUM(R), CysDisplay(R), RapMAT(R), arYla(R), Ylanthia(R), 100 billion high potentials(R), Slonomics(R), Lanthio Pharma(R) and LanthioPep(R) are registered trademarks of the MorphoSys Group. For more information, please contact:
Additional features: Document: http://n.eqs.com/c/fncls.ssp?u=UBEJNXPHSB Document title: Media Release
17.02.2018 Dissemination of a Corporate News, transmitted by DGAP - a service of EQS Group AG. |
Language: | English |
Company: | MorphoSys AG |
Semmelweisstr. 7 | |
82152 Planegg | |
Germany | |
Phone: | +49 (0)89 899 27-0 |
Fax: | +49 (0)89 899 27-222 |
E-mail: | investors@morphosys.com |
Internet: | www.morphosys.com |
ISIN: | DE0006632003 |
WKN: | 663200 |
Indices: | TecDAX |
Listed: | Regulated Market in Frankfurt (Prime Standard); Regulated Unofficial Market in Berlin, Dusseldorf, Hamburg, Hanover, Munich, Stuttgart, Tradegate Exchange |
End of News | DGAP News Service |
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