PROMISE 1 phase III trial of ALD 403 show bennfits in longer treatment for episodic migraine.- Alder Biopharma.

Alder BioPharmaceuticals announced new twelve-month data from its PROMISE 1 Phase III clinical trial of ALD 403 (eptinezumab) in episodic migraine patients. The data demonstrated that patients experienced even further reductions in migraine following the third and fourth quarterly infusions at both dose levels (100mg and 300mg) of eptinezumab, Alder�s lead investigational product candidate for migraine prevention targeting calcitonin gene-related peptide (CGRP). Responder rates for month six through month twelve reveal that 70.7 percent of patients achieved on average a 50 percent reduction or greater of monthly migraine days from baseline compared to 58.7 percent for placebo. This represents an 8.9% improvement from the reductions experienced during the first two quarterly doses of eptinezumab;51.5 percent of patients achieved on average a 75 percent reduction or greater of monthly migraine days from baseline compared to 38.7 percent for placebo. This represents a 12.8% improvement from the reductions experienced during the first two quarterly doses of eptinezumab.

The observed safety profile for PROMISE 1, to date, is consistent with previously reported eptinezumab studies. The most commonly reported adverse events occurring at an incidence of 5 percent or greater across all eptinezumab treatment groups were upper respiratory infection (10.5 percent), nasopharyngitis (common cold) (6.8 percent) and sinusitis (3.6 percent). Detailed results will be presented at the 70th Annual American Academy of Neurology Meeting.