ALDR Alder BioPharmaceuticals Inc

Alder BioPharmaceuticals, Inc. (NASDAQ: ALDR), a biopharmaceutical company focused on developing therapeutic antibodies for the treatment of migraine, today announced dosing of the first patient in a Phase 1 clinical study to evaluate ALD1910 as a preventive treatment for migraine. ALD1910 is an investigational monoclonal antibody (mAb) that inhibits pituitary adenylate cyclase-activating polypeptide (PACAP), an important signaling molecule in the pathophysiology of migraine.

“More than 70% of the 14 million people with migraine who experience more than four headache days per month are not being treated with preventive therapies,” said Bob Azelby, president and chief executive officer of Alder BioPharmaceuticals. “We believe that no single treatment mechanism is going to benefit every person living with this disease. ALD1910 has the potential to provide a new mechanism-specific therapeutic approach for people with migraine and their physicians.”

ALD1910 represents a potential new therapeutic option, focusing on a new pathway in migraine prevention that is distinct from the inhibition of calcitonin gene-related peptide (CGRP), a neuropeptide believed to play a key role in mediating and initiating migraine attacks. PACAP and its receptors have been found across the pain-processing pathway, and increased levels of PACAP have been found in blood samples of patients experiencing a migraine attack.i In preclinical studies, ALD1910 has been shown to be a selective, high-affinity antibody that demonstrated in vivo engagement of the PACAP target.

The Phase 1 double-blind, placebo-controlled study of ALD1910 will enroll approximately 100 healthy men and women between the ages of 18 and 55 and will assess the safety, tolerability and pharmacokinetic profile of ALD1910 at various doses. Initial results are expected in the second half of 2020.

“PACAP is an attractive pathway in addressing migraine and the preclinical work has been very encouraging as it demonstrated ALD1910 prevents the signaling of PACAP with all three known receptors,” said Paul Streck, chief medical officer at Alder. “There is excitement among the medical community to assess the clinical potential of ALD1910 to possibly help patients who may require a different approach for the prevention of migraine.”

About ALD1910Alder is developing ALD1910, an investigational monoclonal antibody (mAb) designed to inhibit pituitary adenylate cyclase-activating polypeptide (PACAP) for migraine prevention. PACAP has emerged as an important signaling molecule in the pathophysiology of migraine and represents an attractive novel target for treating migraine. ALD1910 may hold potential as a migraine prevention treatment for those who have an inadequate response to other therapies and could provide another mechanism-specific therapeutic option for migraine patients and their physicians.

About MigraineMigraine is estimated to be the second leading cause of Years Lived with Disability among all diseases causing disability. More than 134 million people are estimated to experience migraine annually. It is a disabling neurological disease characterized by recurrent episodes of moderate to severe headache accompanied by nausea, vomiting, and sensitivities to light and sound. The occurrence of migraine can be unpredictable with a profound impact on daily activities. Migraine is much more than a bad headache. According to the “Migraine in America” Survey:

• 93% - of those with migraine say migraine affects their ability to work
• 89% - say migraine affects their ability to maintain relationships with their partner
• 86% - say migraine affects their ability to maintain relationships with their children
• 64% - are constantly worried about disappointing people

This disease can last decades, often during what should be the most productive years of patients’ lives. Migraine can remit or progress to chronic migraine over time and persist as chronic migraine for years or decades, but it commonly oscillates between periods of frequent episodic and chronic migraine. Migraine is a complex disease, and heterogeneity is present within each diagnosis and patient’s response to treatment. While there has been significant advancement in the study and treatment of migraine, there continues to be a need for new, effective, and well-tolerated treatment options.

About Alder BioPharmaceuticals, Inc.Alder BioPharmaceuticals is a clinical-stage biopharmaceutical company focused on transforming migraine treatment through the discovery, development and commercialization of novel therapeutic antibodies. Alder’s lead product candidate, eptinezumab, is an investigational monoclonal antibody (mAb) delivered by infusion that inhibits the calcitonin gene-related peptide (CGRP) for the prevention of migraine. A Prescription Drug User Fee Act (PDUFA) target action date has been set for February 21, 2020. If approved, eptinezumab will be the first IV CGRP therapy for migraine prevention. Alder is also developing ALD1910, an investigational mAb that inhibits pituitary adenylate cyclase-activating polypeptide (PACAP) for migraine prevention. For more information, please visit www.alderbio.com.

Forward-Looking Statements This press release contains forward-looking statements, including, without limitation, statements relating to: the potential approval by the FDA of the BLA for eptinezumab; the continued development of eptinezumab and the development of ALD1910; the clinical, therapeutic and commercial potential of eptinezumab and ALD1910; and the belief that eptinezumab and ALD1910 each has the potential to be an important treatment option. Words such as “will,” “potential,” “continue,” “option,” “encouraging,” or other similar expressions, identify forward-looking statements, but the absence of these words does not necessarily mean that a statement is not forward-looking. In addition, any statements that refer to expectations, projections or other characterizations of future events or circumstances are forward-looking statements. The forward-looking statements in this press release are based upon Alder's current plans, assumptions, beliefs, expectations, estimates and projections, and involve substantial risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in the forward-looking statements due to these risks and uncertainties as well as other factors, which include, without limitation: the clinical, therapeutic and commercial value of eptinezumab and ALD1910; risks and uncertainties related to regulatory application, review and approval processes and Alder's compliance with applicable legal and regulatory requirements; risks and uncertainties relating to the build of Alder’s commercialization infrastructure; risks and uncertainties relating to the manufacture and supply of eptinezumab; Alder's ability to obtain and protect intellectual property rights, and operate without infringing on the intellectual property rights of others; the uncertain timing and level of expenses associated with Alder's development and commercialization activities; the sufficiency of Alder's capital and other resources; market competition; changes in economic and business conditions; and other factors discussed under the caption “Risk Factors” in Alder's Quarterly Report on Form 10-Q for the quarterly period ended June 30, 2019, which was filed with the Securities and Exchange Commission (SEC) on August 6, 2019, and is available on the SEC's website at www.sec.gov. Additional information will also be set forth in Alder's other reports and filings it will make with the SEC from time to time. The forward-looking statements made in this press release speak only as of the date of this press release. Alder expressly disclaims any duty, obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in Alder's expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based.

i Tajti, J., et. al. Role of pituitary adenylate cyclase-activating polypeptide in nociception and migraine. https://www.ncbi.nlm.nih.gov/pubmed/25921738#. Accessed September 19, 2019.

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Media Contact:
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Alder BioPharmaceuticals, Inc.
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