Top-line data from pivotal PROMISE 1 study of eptinezumab for migraine prevention on track to be announced 2Q 2017
Conference call set for 5 p.m. EDT today
BOTHELL, Wash., April 27, 2017 (GLOBE NEWSWIRE) -- Alder BioPharmaceuticals, Inc. (NASDAQ:ALDR), a clinical-stage biopharmaceutical company developing monoclonal antibody therapeutics, today announced financial results for the first quarter ended March 31, 2017, and provided a corporate update.
“During the first quarter we remained focused on eptinezumab, our unique and potentially transformative migraine prevention therapy. We are excited about eptinezumab’s clinical data to date and believe that data from our PROMISE 1 Phase 3 pivotal clinical trial, which we expect to announce later this quarter, will further validate our deliberate approach to determining the ideal profile and delivery for a CGRP targeted therapy,” said Randall C. Schatzman, Ph.D., president and chief executive officer of Alder. “We are increasingly confident that eptinezumab’s differentiated delivery and clinical profile, if approved, has the potential to meet a profound need for patients living with chronic and severe frequent episodic migraine and effectively address the U.S. market opportunity for eptinezumab IV, which we estimate to be as high as $2 billion.”
Recent Corporate Highlights
Eptinezumab – Pivotal-stage novel monoclonal antibody targeting the calcitonin gene-related peptide (CGRP) for the prevention of migraine.
- Completed enrollment in the open label pivotal trial which was commenced in December 2016 to evaluate the long-term safety and tolerability of eptinezumab administered via infusion once every 12 weeks for one year in approximately 120 patients.
- Reported 48-week data from the Phase 2b trial evaluating eptinezumab in patients with chronic migraine that continued to demonstrate a safety and tolerability profile similar to placebo and consistent with earlier studies.
- Presented additional data at the 69th Annual American Academy of Neurology meeting from Alder’s eptinezumab program, including additional positive data from the Phase 2b clinical trial of eptinezumab for the prevention of chronic migraine and information describing the rational design objectives and selection of attributes that are important for supporting the desired clinical profile of a migraine prevention therapy.
ALD1910 — Preclinical monoclonal antibody targeting pituitary adenylate cyclase-activating polypeptide-38 (PACAP-38), a protein that is active in mediating the initiation of migraine. Alder believes ALD1910 holds potential as a new preventive option for migraine patients who have an inadequate response to therapeutics directed at CGRP or its receptor
- The company continues to advance ALD1910 through IND-enabling studies
Corporate
Announced the appointment of Wendy L. Yarno, a distinguished executive with more than 30 years of experience in the pharmaceutical industry as a public company director and product commercialization team leader, including 26 years with Merck & Co. Inc., to Alder’s board of directors
- Filed a notice of appeal on March 31, 2017 with the European Patient Office (EPO) with respect to the decision of the EPO Opposition Division (OD) to maintain certain patent claims granted to Teva Pharmaceuticals Industries, Ltd. (Labrys) that the company believes were improperly granted by the EPO and upheld by the OD and should be revoked in their entirety.
Upcoming Eptinezumab Milestones
- Report top-line 12 and 24 week data from the PROMISE 1 (PRevention Of Migraine via Intravenous eptinezumab Safety and Efficacy 1) study in second quarter of 2017. PROMISE 1 is the company’s ongoing Phase 3 pivotal clinical trial that is evaluating the safety and efficacy of eptinezumab administered via infusion once every 12 weeks in patients with frequent episodic migraine in the United States. PROMISE 1 enrollment targeted approximately 800 patients.
- Present additional data at the 59th Annual Scientific Meeting of the American Headache Society from Alder’s eptinezumab program.
- Complete enrollment in the PROMISE 2 (PRevention Of Migraine via Intravenous eptinezumab Safety and Efficacy 2) study in the second half of 2017. PROMISE 2 is the company’s ongoing Phase 3 pivotal clinical trial that is evaluating the safety and efficacy of eptinezumab administered via infusion once every 12 weeks in patients with chronic migraine in the United States. PROMISE 2 is targeting enrollment of approximately 1,050 patients.
First Quarter 2017 Financial Results
