VRDN-001, a Novel IGF-1R Monoclonal Antibody for the Treatment of Thyroid Eye Disease (TED): a Proposed Adaptive Design for Exploratory Proof of Concept

Adaptive design of clinical trials allows for more efficiency and less subject burden than conventional trials in the exploration of effectiveness and safety of drugs. An adaptive strategy is a scheme that allows for prospectively planned modifications to one or more aspects of the design based on accumulated data from subjects within the trial as it is ongoing. Adaptation is planned before comparative analyses of trial data are conducted, allowing opportunities for modifications to the trial itself. VRDN-001 is a humanized IgG1κ monoclonal antibody that binds specifically and with high affinity to human insulin-like growth factor-1 receptor (IGF-1R) and inhibits receptor activation.VRDN-001 is a humanized IgG1κ monoclonal antibody that binds specifically and with high affinity to human insulin-like growth factor-1 receptor (IGF- 1R) and inhibits receptor activation

VRDN-002, a Second-Generation Insulin Like Growth Factor-1 Receptor (IGF-1R) Antagonist Antibody for Thyroid Eye Disease: Preclinical Pharmacokinetic Profile and Clinical Promise

VRDN-002 is a novel anti-IGF-1R antibody incorporating half-life extension modifications in its Fc region for treatment of Thyroid Eye Disease (TED), a condition driven by Thyroid Stimulating Hormone Receptor (TSHR) agonistic autoantibodies and crosstalk between TSHR and IGF-1R. We compared the pharmacokinetic (PK) parameters of VRDN-002 in cynomolgus monkeys to the marketed IGF-1R antibody, teprotumumab, to project potential human dosing regimens