Frontage’s Bioanalytical team partnered with Eisai/Biogen to support the PK and PD biomarker bioanalysis of lecanemab (BAN2401) in their investigational global phase 3 study in US and China. Recently Eisai/Biogen publicly shared the favorable results of the lecanemab (BAN2401) Clarity AD study which Eisai presented on November 29, 2022, at the Clinical Trials on Alzheimer’s Disease Congress (CTAD), and published the findings in NEJM. The Frontage team developed and validated the LC-MS-based PK method back in 2010 and provided bioanalytical support to this program from clinical Phase 1 to the late phase trial. Frontage’s scientific team also provided biomarker analysis (p-Tau181, NfL, and GFAP) for this Phase 3 study and met the very aggressive timelines of data lock. What Eisai/Biogen have achieved offers real hope to the patient, their families, and all the people who care about them.
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“Here at Frontage, we also celebrated this news because it’s a powerful reminder of the reason we are in this field–to work towards combating disease and positively improving the lives of others. We are very proud to have worked closely with our Eisai partners to support the bioanalysis of lecanemab (BAN2401) in this large global phase 3 study. We are extremely proud to be a part of the team and hope to contribute to the unmet medical needs of patients with Alzheimer’s disease,” announces John Lin, Frontage’s EVP and Global Head, Bioanalytical and Biologics Services.
Frontage Holdings Corp (1521.HK), together with its wholly owned subsidiary Frontage Laboratories, Inc., is a global Contract Research Organization (CRO) that provides integrated, science-driven, product development services from drug discovery to late-phase clinical process to enable biopharmaceutical companies to achieve their development goals. Comprehensive services include drug metabolism and pharmacokinetics, analytical testing and formulation development, preclinical and clinical trial material manufacturing, bioanalysis, preclinical safety and toxicology assessment, and early-phase clinical studies. Frontage has enabled many biotechnology companies and leading pharmaceutical companies of varying sizes to advance a myriad of new molecules through development and to successfully file global regulatory submissions.
SOURCE: PR Newswire