Alder BioPharmaceuticals Presents New Data from Clinical Trials

Alder BioPharmaceuticals (NASDAQ:ALDR) has released new data showing consistency of early migraine prevention benefit in four clinical trials with eptinezumab.

As quoted in the press release:

Eptinezumab is an investigational monoclonal antibody (mAb) targeting the calcitonin gene-related peptide (CGRP) and is administered by quarterly infusion for migraine prevention. Detailed data will be presented today at the 71^st AAN Annual Meeting in Philadelphia, PA.

Across the Phase 2 and Phase 3 clinical trials, it was observed that eptinezumab, facilitated by its 100% bioavailability at the end of infusion, showed a rapid onset of migraine prevention. The rapid response observed within Day 1 and Month 1 was sustained through the first quarter following infusion, maintained or further increased through subsequent infusions and consistent across four clinical trials.  Safety and tolerability were evaluated in the eptinezumab clinical trials. No serious adverse drug reactions related to eptinezumab were identified within the clinical trial program.

“I’m excited to see the early onset migraine prevention that eptinezumab can potentially bring to millions of people who are impacted by this debilitating disease,” said Roger K. Cady, M.D., vice president, neurology of Alder BioPharmaceuticals. “During my time in clinical practice, my patients with migraine were consistently looking for new treatment options. These data continue to support the potential of eptinezumab to be a meaningful treatment option for those impacted with the burden of migraine, if approved.”

Highlights from the Phase 3 Early Relief Data include¹:

• Episodic Migraine:
  • 52.3% reduction in the percentage of patients with a migraine on Day 1 in those treated with 100 mg eptinezumab and 54.9% in those treated with 300 mg eptinezumab compared to 24.5% for placebo

Click here to read the full press release.