NEW YORK, May 3, 2021 – Ichnos Sciences Inc., a global biotechnology company developing innovative biologic treatments in oncology and autoimmune diseases, today presented positive data from a Phase 2b study of telazorlimab in atopic dermatitis (AD) at the 2021 Society for Investigative Dermatology (SID) Virtual Meeting. The presentation was made by Lawrence D. Sher, M.D., who is board-certified in adult and pediatric asthma, allergy and immunology and pediatrics and the lead investigator in the study.
For the primary analysis, this international two-part study randomized a total of 462 adults with moderate-to-severe AD and assigned them to one of four telazorlimab treatment arms or one of two matching placebo arms administered subcutaneously over a 16-week blinded dosing period. Participants then continued in a 38-week open label extension during which all subjects received active treatment with telazorlimab and a 12-week follow-up period when no study drug was given.
At the end of the double-blind portion of the study, for the primary efficacy endpoint of % change in Eczema Area and Severity Index (EASI) score from baseline to Week 16, the two highest doses of telazorlimab, 300 mg and 600 mg administered every two weeks, were statistically superior to placebo (p < 0.05). During the same time period, clinical improvements in the secondary efficacy endpoints of EASI-75 and Investigator Global Assessment (IGA) were also observed and were generally numerically higher for telazorlimab than placebo. This difference reached statistical significance in EASI-75 for the dosing arm that administered telazorlimab 300 mg every two weeks. Preliminary data from this study suggest that clinical efficacy continues to improve after Week 16 with maximal impact achieved several weeks later, and the reduction in AD disease activity may be maintained without additional therapeutic intervention after discontinuation of telazorlimab, through three months of follow-up.
“Many patients with atopic dermatitis continue to experience symptoms while on therapy,” said Dr. Sher. “There is a need to identify and develop new treatments such as telazorlimab that target distinct pathways and have the potential to improve and maintain disease control.”
Telazorlimab was well-tolerated during the study to date. The most commonly reported adverse events (>5%) were atopic dermatitis, nasopharyngitis, upper respiratory tract infection, and headache. One patient with pre-existing hypertension in the telazorlimab group died due to a presumed cardiovascular event during the treatment period. The investigator considered the death to be unrelated to the study drug.
“Preliminary results of this large, ongoing Phase 2b study of telazorlimab confirm the potential contribution of OX40 signaling in inflammatory skin diseases, including atopic dermatitis,” said Alessandro Riva, M.D., Chief Executive Officer of Ichnos Sciences. “We believe that blocking this pathway with telazorlimab may also be a viable treatment approach in seropositive autoimmune diseases such as rheumatoid arthritis.”
The entire presentation is available for viewing on the Ichnos website.
A U.S. IND for the study of telazorlimab in seropositive autoimmune indications is active. Ichnos plans to out-license this compound and ISB 880, an IL-1RAP antagonist antibody, to focus on immune-cell engager biologics in oncology.
A fully integrated, global biotech with the spirit of a start-up, Ichnos is shifting the way the world thinks about innovation in medicine through its research and development of transformative, disease-centric treatments in oncology and autoimmune diseases. The company, with headquarters in New York, N.Y., is rapidly advancing a clinical-stage pipeline of novel, first-in-class candidates designed to address complex diseases and to treat patients holistically. With a patented BEAT® technology platform, along with pioneering teams at two locations in Switzerland, Ichnos Sciences has a mission to provide breakthrough, curative therapies that will extend and improve lives, writing a new chapter in healthcare. For more information, visit IchnosSciences.com.