AFVT-2101

AFVT-2101 was well-tolerated with no test article-related adverse effects on clinical observations, bodyweight, clinical chemistry, hematology, coagulation, anatomic pathology, or immunotoxicity parameters. The no observed adverse effect level (NOAEL) was determined to be 150 mg/kg under the conditions of the study.The safety profile is being further evaluated in an ongoing pivotal 4-week GLP study incorporating standard toxicology endpoints, safety pharmacology (CNS, CV, and respiratory), gross and anatomic pathology, as well as cytokine, immunophenotyping, receptor occupancy, TK, and ADA analyses.In conclusion, AFVT-2101 is well-tolerated in NHPs with a pharmacokinetic and safety profile consistent with its intended clinical application.