Still leery about an­i­mal deaths, FDA lifts a full hold on Friedre­ich’s atax­ia drug — but there’s a big con­di­tion

Lit­tle Lari­mar Ther­a­peu­tics has fi­nal­ly worked its way out of reg­u­la­to­ry lim­bo.

Kind of.

The biotech re­port­ed that the FDA has lift­ed its full clin­i­cal hold on CTI-1601 in Friedre­ich’s atax­ia, im­posed 16 months ago. And they’ve re­placed it with a par­tial hold.

Ac­cord­ing to a state­ment from the com­pa­ny, the FDA is green­light­ing a 25 mg co­hort of a Phase II study in FA.

From Lari­mar:

The de­sign of the up­com­ing Phase 2 tri­al is iden­ti­cal to the de­sign pro­posed by Lari­mar, with the ex­cep­tion of a re­quire­ment for the FDA to re­view da­ta from the 25 mg co­hort pri­or to es­ca­lat­ing the dose in the sec­ond co­hort. Lari­mar ex­pects to be­gin the Phase 2 tri­al in Q4 2022, with top-line da­ta ex­pect­ed in 2H 2023.

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