Imara's Thalassemia Candidate Shows Reduced Transfusion Burden At Higher Dose

Imara Inc IMRA has announced data from a pre-specified interim analysis from its Forte Phase 2b trial of tovinontrine (IMR-687) in transfusion-dependent subjects (TDT) with beta-thalassemia.
Subjects in the Forte trial were randomized to either a lower dose group (200 mg or 300 mg), higher-dose group (300 mg or 400 mg), or placebo.
The median baseline transfusion burden in each higher dose tovinontrine and placebo group was 7.5 red blood cell (RBC) units/12 weeks.
Interim data from the Forte study demonstrated tovinontrine was well-tolerated, with the most frequent adverse being nausea, headache, and dizziness.
Four (9.3%) subjects discontinued due to adverse events considered related to the study drug.
The proportion of subjects who had over 33% reduction in transfusion burden (of at least two units) was greater in the higher dose tovinontrine group (7/8) versus placebo, despite an unexpectedly high response rate in the placebo group (8/12).
Lower dose tovinontrine did not show a higher response rate when compared to the placebo group. No substantial differences between groups were observed in the transfusion burden response rate.
Additional data will be presented as part of a key efficacy analysis expected in Q1 of 2022.
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