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Nuvelo initiates enrollment for Phase I study of recombinant drug

Nuvelo has enrolled the first subject in a single-center, Phase I trial of recombinant, secreted protein, NU206, the company's lead compound from its Wnt Therapeutics program.

This double-blind, placebo-controlled, single-ascending dose (SAD) trial will determine the safety, tolerance and pharmacokinetics of a single intravenous (IV) administration of NU206, in approximately 48 healthy male volunteers. Participants will be enrolled in up to six cohorts of varying doses, with a maximum dose of 0.80mg/kg.

NU206 (R-spondin1) is a recombinant, secreted protein that acts as a key regulator of the Wnt pathway, the critical pathway that stimulates cell growth and differentiation during homeostasis and pathogenesis in specific tissues including the gastrointestinal epithelium and bone.

Ted Love, chairman and CEO of Nuvelo, said: “The initiation of this healthy volunteer trial, coupled with the Phase Ib multiple-ascending dose study that will start later this year or early next year, allows us to accelerate NU206 development.”