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ARTICLE | Clinical News

Prothena completes enrollment in Phase IIb amyloidosis trial

May 17, 2017 9:01 PM UTC

Prothena Corp. plc (NASDAQ:PRTA) said it completed enrollment of 129 patients with amyloid light-chain (AL) amyloidosis who had a hematologic response to previous treatment and have persistent cardiac dysfunction in the Phase IIb PRONTO trial of NEOD001. The company expects top-line data in 2Q18.

The double-blind, placebo-controlled, international trial is evaluating 24 mg/kg IV NEOD001 every 28 days. The primary endpoint is cardiac best response. The secondary endpoints are change from baseline to 12 months in Short Form 36 (SF-36) questionnaire, 6-minute walk test (6MWT), renal best response, neuropathy impairment score, progression-free survival (PFS) and safety...

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