Alder Reports Phase 2b Trial Of ALD403 Meets Primary And Secondary Endpoints

(RTTNews) - Alder BioPharmaceuticals, Inc. (ALDR) announced positive top-line data from two clinical trials evaluating ALD403, Alder's proprietary monoclonal antibody product candidate for migraine prevention that targets calcitonin gene-related peptide or CGRP. Positive top-line data from a Phase 2b study of patients with chronic migraine demonstrated that ALD403 acted rapidly and prevented migraine over the entire 12 week study period, meeting both primary and secondary efficacy endpoints.

Additionally, positive Phase 1 study data demonstrated that the pharmacokinetics and pharmacodynamics by intravenous (IV), subcutaneous (SC) or intramuscular (IM) injection of ALD403 support a quarterly single injection dosing strategy.

The Phase 2b clinical trial is a double-blind, placebo-controlled, randomized, single intravenous infusion, dose ranging study in patients with chronic migraine. Patients were randomized to receive a single intravenous infusion of 10 mg, 30 mg, 100 mg or 300 mg of ALD403 or placebo (approximately 120 patients per group). The primary efficacy endpoint of the study is the change in migraine days between ALD403 and placebo as determined by the 75% responder rates over a 12-week period. Endpoints will also be evaluated at week 24 (expected Q3 2016) and at week 48 (end of study).

Chronic migraine sufferers are defined as individuals who experience 15 or more headache days per month, of which at least 8 must be assessed as migraine days.

The 300 mg and 100 mg dose levels of ALD403 met the primary efficacy endpoint of the study, a 75% reduction in migraine days over the entire 12 weeks in 33% and 31% of patients, respectively (p < 0.05).