Shots:
- Alebund has completed patient enrollment in the global P-III (RESPOND-2) trial assessing AP301 for the treatment of hyperphosphatemia across the US (n=138) & China (n=144)
- The RESPOND-2 trial enrolled 282 pts (planned n=264) aged ≥12yrs with chronic kidney disease on maintenance dialysis with hyperphosphatemia & incl. an 8wk. double-blind phase, a 24wk. open-label phase, & a 3wk. randomized withdrawal phase comparing AP301 maintenance dose vs ineffective low dose
- Based on P-III (RESPOND-1) China trial data, Alebund plans a China NDA submission following alignment with the NMPA, while the US FDA has agreed that the ongoing global P-III trial can serve as the single pivotal study supporting US registration
Ref: PRnewswire | Image: Alebund |Press Release
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