Alpine: FDA Places Partial Clinical Hold On NEON-2 Trial Prompted By Grade 5 Adverse Event

(RTTNews) - Alpine Immune Sciences, Inc. (ALPN) announced the FDA has placed a partial clinical hold on its NEON-2 trial evaluating davoceticept (ALPN-202) in combination with pembrolizumab in adults with advanced malignancies. This was prompted by Alpine's report of patient death in the NEON-2 trial.

"Given the strong scientific rationale for the combination of davoceticept and pembrolizumab to benefit treatment-refractory patients, we are hopeful that the study will soon be resumed after appropriate safety review, and with appropriate safety precautions in place," said Mitchell Gold, CEO of Alpine.