Larimar to kick off higher dose of lead rare disease drug, initiate OLE trial

The FDA gave Lari­mar Ther­a­peu­tics the go-ahead to in­tro­duce a high­er dose of its Friedre­ich’s atax­ia treat­ment in a Phase II study.

The biotech an­nounced Tues­day that the com­pa­ny can now use 50 mg dos­es of its lead drug, al­so known as CTI-1601, in the study. The 12 to 15 adult pa­tients Lari­mar plans to en­roll in that co­hort will be ran­dom­ized to ei­ther the drug or place­bo, then dosed every day for the first two weeks.

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