Alder BioPharmaceuticals Announces Positive Results From Pharmacokinetic Comparability Study for Eptinezumab

Alder Biopharmaceuticals (NASDAQ:ALDR), a biopharmaceutical company focused on developing novel therapeutic antibodies for the treatment of migraine, today announced positive results from a comparative pharmacokinetic (PK) study intended to support the comparability evaluation of the clinical supply for eptinezumab and its planned commercial supply. Eptinezumab is Alder’s lead investigational product candidate for migraine prevention targeting calcitonin gene-related peptide (CGRP).

As quoted in the press release:

“We are pleased that the PK study has met our objective of demonstrating the comparability of eptinezumab,” said Dr. Eric Carter, interim chief medical officer of Alder. “These positive results, combined with our chemistry, manufacturing, and controls (CMC) and clinical data packages, comprise what we believe will be a high-quality Biologics License Application (BLA) submission. We remain on track to submit our BLA with the U.S. Food and Drug Administration (FDA) in the first quarter of 2019.”

The PK study (ALD403-CLIN-014) was designed to confirm that the planned commercial supply of eptinezumab had a comparable pharmacokinetic profile to the eptinezumab that was utilized in Alder’s clinical trials. Comparative PK profiles were demonstrated between the test and reference products; both the primary and key secondary PK results met the standard pre-specified acceptance criteria for drug product comparability. Further, the test and reference products were well-tolerated with a similar adverse event profile, and this safety profile was consistent with what has previously been reported for eptinezumab.

Click here to read the full press release.