FDA lifts par­tial clin­i­cal hold on Vig­il Neu­ro­science's TREM2 an­ti­body, re­mov­ing dos­ing cap

When Vig­il Neu­ro­science filed its IPO pa­pers in late 2021, the biotech re­vealed that the FDA had just cleared its Phase I tri­al — but with a par­tial clin­i­cal hold that lim­it­ed dos­ing to un­der a cer­tain lev­el.

More than a year lat­er, the FDA has lift­ed the hold.

Vig­il is now free to dose VGL101, an an­ti­body tar­get­ing TREM2, at lev­els high­er than 20 mg/kg in its on­go­ing and fu­ture clin­i­cal tri­als in pa­tients with adult-on­set leukoen­cephalopa­thy with ax­on­al spher­oids and pig­ment­ed glia (AL­SP), an in­her­it­ed con­di­tion that af­fects the brain and spinal cord.

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