공지 • Sep 09
Amgen and Kyowa Kirin Co., Ltd. Announce Top-Line Results from Roccatinlimab Phase 3 ASCEND Long-Term Extension Study in Results with Moderate to Severe Atopic Dermatitis
AMgen and Kyowa Kirin Co., Ltd. announced preliminary top-line results from the ASCEND study evaluating rocatinlimab, an investigational T-cell rebalancing therapy targeting the OX40 receptor, in adults and adolescents with moderate to severe atopic dermatitis (AD). The ongoing ASCEND study, which includes approximately 2,600 patients, is designed to evaluate the long-term safety and efficacy of rocatinlimab (150 mg and 300 mg) administered every four or eight weeks in individuals who completed a previous ROCKET program trial (IGNITE, HORIZON, SHUTTLE, ASTRO, ORBIT or VOYAGER). ASCEND is part of the larger ROCKET Phase 3 clinical program. ROCKET is a comprehensive, global Phase 3 clinical program composed of eight studies intended to establish the safety and efficacy profile of multiple dosing regimens of rocatinlimab in adults and adolescents with moderate To severe AD as well as multiple dosing regimens. All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements, including any statements on the outcome, benefits and synergies of collaborations, or potential collaborations, with any other company (including BeOne Medicines Ltd. or Kyowa Kirin Co., Ltd.), the performance of Otezla®? (apremilast), acquisitions of ChemoCentryx Inc. or Horizon Therapeutics plc (including the prospective performance and outlook of Horizon's business, performance and opportunities, and any potential strategic benefits, syner gies or opportunities expected as a result of such acquisition), as well as estimates of revenues, operating margins, capital expenditures, cash, other financial metrics, expected legal, integration, political, regulatory or clinical results or practices, customer and prescriber patterns or practices, reimbursement activities and outcomes, effects of pandemics or other widespread health problems on business, outcomes, progress, and other such estimates and results. No forward-looking statement can be guaranteed and actual results may differ materially from those project. Discovery or identification of new product candidates or development of new indications for existing products cannot be guaranteed and movement from concept to product is uncertain; consequently, there can be no guarantee that any particular product candidate or development of a new indication for an existing product will be successful and become a commercial product. Further, preclinical results do not guarantee safe and effective performance of product candidates in humans. The length of time that it takes for to complete clinical trials and obtain regulatory approval for product marketing has in the past varied and expect similar variability in the future. Even when clinical trials are successful, regulatory authorities may question the sufficiency for approval of the trial endpoints have selected. The company develop product candidates internally and through licensing collaborations, partnerships and joint ventures. The results may be affected by the ability to successfully market both new and existing products domestically and internationally, clinical and regulatory developments involving current and future products, sales growth of recently launched products, competition from other products including biosimilars, difficulties or delays in manufacturing products and global economic conditions, including those resulting from geopolitical relations and government actions. An outbreak of disease or similar public health threat, and the public and governmental effort to mitigate against the spread of such disease, could have a significant adverse effect on the supply of materials for manufacturing activities, the distribution of products, the distribution of products, The distribution of products, the commercialization of product candidates, and the commercialization of product candidate, and the clinical trial operations, and any such events may have a material adverse effect on product development, product sales, business and results of operations. In addition, the company compete with other companies with respect to many of marketed products as well as for the discovery and development of new products. The discovery of significant problems with a product similar to one of products that implicate an entire class of products could have a material adverse effect on sales of the affected products and on business and results of operations. The scientific information discussed in this news release related to product candidates is preliminary andative. Such product candidates are not approved by the U.S. Food and Drug Administration, and Drug Administration, and Drug administration, and Drug Administration, and no investigational.