BOTHELL, Wash., Sept. 15, 2016 (GLOBE NEWSWIRE) — Alder BioPharmaceuticals, Inc. (NASDAQ:ALDR), a clinical-stage biopharmaceutical company developing monoclonal antibody therapeutics, today 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
About Alder BioPharmaceuticals, Inc.
Alder BioPharmaceuticals, Inc., is a clinical-stage biopharmaceutical company that discovers, develops and seeks to commercialize genetically engineered therapeutic antibodies with the potential to meaningfully transform current treatment paradigms. Alder’s lead pivotal-stage product candidate, ALD403, is being evaluated for migraine prevention. ALD403 is a monoclonal antibody that inhibits calcitonin gene-related peptide (CGRP), a protein that is active in mediating the initiation of migraine. Alder is additionally evaluating ALD1910, a preclinical product candidate also in development as a migraine prevention therapy. ALD1910 is a monoclonal antibody that inhibits pituitary adenylate cyclase-activating polypeptide-38 (PACAP-38), another protein that is active in mediating the initiation of migraine. Clazakizumab, Alder’s third program, is a monoclonal antibody candidate that inhibits interleukin-6 and is licensed to Vitaeris, Inc. For more information, please visit http://www.alderbio.com.
Forward-Looking Statements
This press release contains forward-looking statements, including, without limitation, statements relating to: the continued development and clinical, therapeutic and commercial potential of ALD403; and the initiation of future clinical trials and studies. Words such as “continues,” “support,” “potential,” “encouraged,” “may,” “look forward,” 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: risks related to the potential failure of ALD403 to demonstrate safety and efficacy in clinical testing; Alder’s ability to conduct clinical trials of ALD403 sufficient to achieve a positive completion; the availability of data at the expected times; the clinical, therapeutic and commercial value of ALD403; risks and uncertainties related to regulatory application, review and approval processes and Alder’s compliance with applicable legal and regulatory requirements; the uncertain timing and level of expenses associated with the development of ALD403; 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, 2016, which was filed with the Securities and Exchange Commission (SEC) on July 26, 2016, 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.
CONTACT: Media Contacts: David Schull or Todd Davenport, Ph.D. Russo Partners, LLC (212) 845-4271 (212) 845-4235 [email protected] [email protected] Investor Relations Contact: David Walsey Alder BioPharmaceuticals (425) 408-8032 [email protected]