Alder BioPharma (ALDR) Announces Presentation of Positive ALD403 Phase 2b Data in Migraine Prevention

September 15, 2016 8:01 AM EDT

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Alder BioPharmaceuticals, Inc. (Nasdaq: ALDR) announced the presentation of data from Phase 2b and Phase 1 clinical trials of ALD403 for the prevention of migraine as well as preclinical data from a case study of ALD403 and other CGRP-antibodies at the 5th European Headache and Migraine Trust International Congress (EHMTIC 2016) in Glasgow, Scotland.

“The data presented today continues to support the potential of ALD403 to provide a differentiated, best-in-class migraine prevention therapy,” said Randall C. Schatzman, Ph.D., president and chief executive officer of Alder. “We are particularly encouraged by the robust and immediate benefits of migraine prevention demonstrated after a single, infrequent, quarterly administration of ALD403. Furthermore, additional data demonstrated other clinical benefits such as a significant reduction in severe migraines. This may help patients to improve the quality of their lives as they reclaim days that might otherwise have been lost to migraine. We look forward to initiating our pivotal study of ALD403 in patients living with chronic migraine, PROMISE 2, later this year.” Key Points:

Poster presentation: “Randomized, Double-Blind, Placebo-Controlled Trial of ALD403, an Anti-CGRP Peptide Antibody in the Prevention of Chronic Migraine”

  • A single intravenous (IV) dose of ALD403 300mg IV or 100mg IV met the primary endpoint of the Phase 2b trial with a significant number of patients achieving at least a 75% reduction in their migraine days versus placebo over weeks 1-12
  • A single administration of ALD403 300mg, 100mg or 30mg IV demonstrated a significant difference from placebo for mean change from baseline in migraine days per month over weeks 1-12
  • ALD403 had a rapid onset of action after a single IV dose as demonstrated by significant separation from placebo in the first month (weeks 1-4) after dosing for the 50% and 75% responder rates
  • A single administration ALD403 300mg, 100mg, 30mg or 10mg significantly reduced the number of severe migraines reported by patients relative to placebo (weeks 1-12)
  • ALD403 given to patients with chronic migraine as a single IV dose of 300mg, 100mg, 30mg and 10mg was safe and well tolerated
  • This efficacy and safety data support the progression of ALD403 into Phase 3 clinical trials for chronic migraine

Poster presentation: “A Multiple-Dose, Phase I Placebo-Controlled, Randomized Study of ALD403, An Anti-CGRP Antibody, Administered Every 3-Months via IV, SC or IM”

  • The pharmacokinetic and pharmacodynamic results support further evaluation in later stage clinical trials of 100mg ALD403 IV, subcutaneous (SC), or intramuscular (IM) or 300mg IM administration once every three months
  • IM injections of ALD403 resulted in higher absolute bioavailability for ALD403 when compared to the SC route
  • High absolute bioavailability combined with a higher accumulation ratio resulted in increased overall exposure to ALD403 after IM administration relative to IV or SC as determined by the dose normalized AUC values following the second treatment

Poster presentation: “Characterization of the Binding of Three Anti-CGRP Antibodies Effective in Preventing Migraine: A Comparative Case Study of ALD403, LY-2951742, TEV-48125”

  • Preclinical data comparing the binding kinetics of ALD403 to two other anti-CGRP monoclonal antibodies demonstrated that subtle differences in antibodies targeting the same ligand can alter characteristics important for leveraging a particular therapeutic axis and optimizing commercial as well as clinical utility
  • The data generated from the three anti-CGRP antibodies engineered into a common immunoglobulin scaffold demonstrated differences in the intrinsic binding features among the antibodies tested
  • ALD403 bound differentially from the other anti-CGRP antibodies studied and bound to CGRP with high affinity and rapid target engagement

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