Applied Therapeutics Reports P-III trial (INSPIRE) Results of AT-007 for Sorbitol Dehydrogenase Deficiency
Shots:
- The ongoing P-III trial (INSPIRE) evaluating the effect of AT-007 (qd) in ~50 patients aged 16-55yrs. in the US & EU. In a pre-specified interim analysis, AT-007 showed a reduction in sorbitol levels by a mean of ~52% over 90 days of treatment
- A baseline cross-sectional analysis demonstrated a significant correlation b/w sorbitol level & clinical outcome measure, incl. 10-meter-walk/run speed, 4-stair climb speed & sit-to-stand test. The 12mos. interim clinical outcomes assessment will be conducted as part of (INSPIRE) study in a blinded manner
- The study will be finished & unblinded if the primary outcome measure (10-meter walk/run) reaches statistical significance after 12mos. Otherwise, the study will proceed with a blinded design for another 24mos.
Ref: PRNewswire | Image: RenalGuard Therapy
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