Levo Product Joins List Of Prader-Willi Syndrome Trial Failures
But Company Confident About Lower Dose Of Intranasal Carbetocin
Attempts at developing an effective therapy for PWS, and the abnormal desire for food associated with the rare disorder, have been fruitless but Levo Therapeutics' enthusiasm for LV-101 remains high, despite a Phase III setback.
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The US biotech has released new positive data from two late-stage studies in the rare disease after the US FDA asked for more controlled data following an initial disappointment.
US FDA points to inconsistency in Phase II and Phase III study results, lack of additional substantiating studies and lack of robust statistical findings. Advisory committee is to vote on whether there is ‘substantial evidence’ that the nasal spray is effective in treatment of hyperphagia associated with Prader-Willi syndrome.
The center is partnering with Obsidian to make autologous TILs work better after being infused back into patients by using IL-15, which may be less toxic than the high-dose IL-2 currently used.