DGAP-News: MorphoSys AG / Key word(s): Study results
Planegg/Munich, Germany, December 12, 2018
MorphoSys's Licensee Janssen Announces Data from the Phase 3 Head-to-Head Study ECLIPSE Demonstrating Superiority of Tremfya(R) vs. Cosentyx(R) as Measured by PASI 90 at Week 48 in the Treatment of Plaque Psoriasis
MorphoSys AG (FSE: MOR; Prime Standard Segment, MDAX & TecDAX; NASDAQ: MOR) reported today that its licensee Janssen has announced that results from the ECLIPSE study demonstrated that Tremfya(R) (guselkumab) was superior to Cosentyx(R) (secukinumab) in treating adults with moderate to severe plaque psoriasis for the primary endpoint of a PASI 90 response at week 48. According to a press release published by Janssen today, data from the multi-center, randomized, double-blind, head-to-head phase 3 study ECLIPSE demonstrated that 84.5 percent of patients treated with Tremfya(R) achieved at least 90 percent improvement in their baseline Psoriasis Area Severity Index (PASI) score at week 48, compared with 70.0 percent of patients treated with Cosentyx(R) (p<0.001). The data, which will be presented today at 5:30pm CET at the 3rd Inflammatory Skin Disease Summit in Vienna, Austria, mark the first-ever results from a head-to-head study comparing an interleukin (IL)-23-targeted biologic therapy (Tremfya(R)) with an IL-17 inhibitor (Cosentyx(R)).
Tremfya(R) is a human anti-IL-23 monoclonal antibody developed by Janssen, and was generated utilizing MorphoSys's proprietary HuCAL technology. MorphoSys is eligible to certain milestone payments and receives royalties on net sales of Tremfya(R).
Dr. Markus Enzelberger, Chief Scientific Officer of MorphoSys AG, said: "We are very pleased about the data from the ECLIPSE trial presented today. Moderate to severe plaque psoriasis is an immune-mediated and highly debilitating disease and we believe that patients particularly need effective long-term treatment options for this chronic illness. We are glad that there are many good treatment options available for patients suffering from this disease and we believe that the results of the ECLIPSE study will help guide clinical practice in this disease."
ECLIPSE incorporated six major secondary endpoints that used a fixed statistical sequence procedure to control for multiple comparisons and included both shorter and longer-term analyses. Tremfya(R) demonstrated non-inferiority to Cosentyx(R) in the first major secondary endpoint, with 84.6 percent of patients on Tremfya(R) achieving a PASI 75 response at both weeks 12 and 48 vs. 80.2 percent of those on Cosentyx(R) (p<0.001), however, it did not demonstrate superiority (p=0.062). Because superiority was not demonstrated for the first major secondary endpoint, p-values for all the subsequent major secondary endpoints were considered nominal.
Three of the remaining major secondary endpoints evaluated efficacy at week 48, including achievement of a PASI 100 response and Investigator's Global Assessment (IGA) scores of 0 (cleared), or 0 or 1 (cleared or minimal disease). At week 48, 58.2 percent of patients receiving Tremfya(R) achieved a PASI 100 response, compared with 48.4 percent of patients receiving Cosentyx(R); 62.2 percent of patients receiving Tremfya(R) achieved an IGA score of 0 compared to 50.4 percent of patients receiving Cosentyx(R); and 85.0 percent of patients receiving Tremfya(R) achieved an IGA score of 0 or 1 compared to 74.9 percent of patients receiving Cosentyx(R) (all comparisons with nominal p<= 0.001).
The remaining major secondary endpoints assessed non-inferiority of Tremfya(R) versus Cosentyx(R) at week 12. The percentage of patients achieving a PASI 75 response at week 12 was 89.3 percent for Tremfya(R) and 91.6 percent for Cosentyx(R) (p<0.001 for non-inferiority); the percentage of patients achieving a PASI 90 response at week 12 was 69.1 percent for Tremfya(R) and 76.1 percent for Cosentyx(R) (p=0.127 for non-inferiority).
According to Janssen, the safety profiles observed for Tremfya(R) and Cosentyx(R) in ECLIPSE were consistent with the known safety profiles seen in the respective registration trials and current prescribing information.
Tremfya(R) has been approved in the U.S., Canada, the European Union, and several other countries for the treatment of plaque psoriasis and in Japan for the treatment of various forms of psoriasis, psoriatic arthritis, and palmoplantar pustulosis. Tremfya(R) is currently being investigated in clinical studies in several indications, including plaque psoriasis, in pediatric psoriasis, psoriatic arthritis, Crohn's disease, and hidradenitis suppurativa.
Further information can be found in a press release issued by Janssen on December 12, 2018.
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. Tremfya(R) is a trademark of Janssen Biotech, Inc. Cosentyx(R) is a trademark of Novartis AG.
For more information, please contact:
Tel: +49 (0) 89 / 899 27-404
Document title: Media Release
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