Single IV Dose of ALD403 Demonstrates Efficacy Over Six Months for the Preventive Treatment of Migraine
BOTHELL, WA, USA I May 15, 2015 I Alder BioPharmaceuticals, Inc. (“Alder”) (ALDR), a clinical-stage biopharmaceutical company developing monoclonal antibody therapeutics for the treatment of migraine, announced that six-month follow-up data from its Phase 2 proof-of-concept clinical trial of ALD403, its anti-calcitonin gene-related peptide (CGRP) antibody for the prevention of frequent episodic migraine, were presented today by Jeffrey T.L. Smith, M.D., FRCP, Senior Vice President, Translational Medicine at Alder, in an oral presentation at the 17th Congress of the International Headache Society in Valencia, Spain.
Key Points from Oral Session: Migraine Pathophysiology and CGRP as a Therapeutic Target:
- A single intravenous dose of ALD403 1000mg demonstrated prolonged efficacy over six months for the preventive treatment of migraine.
- Over three months, the proportion of patients with a 50%, 75%, and 100% reduction in migraine days for ALD403 and placebo was 61% vs 33% (p < 0.001); 33% vs 9% (p < 0.001); and 16% vs 0% (p < 0.001), respectively.
- Over six months, the proportion of patients with a 50%, 75%, and 100% reduction in migraine days for ALD403 and placebo was 53% vs 28% (p < 0.001); 26% vs 7% (p < 0.002); and 11% vs 0% (p <0.002), respectively.
- ALD403 was well tolerated and there were no differences from placebo in terms of adverse events or laboratory safety data.
- The migraine prevention proof-of-concept trial was conducted in 163 patients with frequent episodic migraine who had on average nine headache days per month. Patients were given a single intravenous dose of 1000mg of ALD403 or placebo. The primary endpoint was the mean change in migraine headache days from baseline to weeks 5-8, and patients were followed for 24 weeks for additional safety and efficacy analyses.
Alder also presented a poster with Phase 1 data for ALD403 titled, “A Single Dose Placebo-Controlled, Randomized, Ascending Dose Study of ALD403, a Humanized Anti-Calcitonin Gene-Related Peptide Monoclonal Antibody Administered IV or SC — Pharmacokinetic and Pharmacodynamic Results.”
ALD403 is Alder’s transformative novel monoclonal antibody that targets CGRP for prevention of migraine. CGRP is a small protein involved in the transmission of and heightened sensitivity to pain experienced in migraine.
Quote:
Randall C. Schatzman, Ph.D., President and Chief Executive Officer of Alder, said, “We believe that ALD403 has the potential to transform migraine prevention. These data presented today demonstrate the durable efficacy of ALD403 over six months, and we are now focused on identifying the optimal once-quarterly dose of ALD403 for both infusion and self-administration formulations. To this end, we plan to initiate two additional dose-ranging clinical trials in the second half of this year. We believe that providing patients and physicians the choice between these two routes of administration will allow a customized treatment paradigm that best suits each individual patient’s preference and circumstances.”
About Alder BioPharmaceuticals
Alder BioPharmaceuticals, Inc. is a clinical-stage biopharmaceutical company that discovers, develops and seeks to commercialize therapeutic antibodies with the potential to meaningfully transform current treatment paradigms. Alder’s lead clinical candidate, ALD403, inhibits a well-validated molecule shown to trigger migraine attacks, calcitonin gene-related peptide (CGRP), and is currently undergoing Phase 2b clinical testing for the treatment of chronic migraines. Alder plans to initiate additional advanced clinical studies for ALD403 in frequent episodic and chronic migraines in the second half of 2015. Alder’s second program, ALD1613, which targets adrenocorticotropic hormone (ACTH) is undergoing Investigational New Drug (IND)-enabling preclinical studies with the initiation of clinical studies in Cushing’s disease planned for 2016. Finally, clazakizumab, previously known as ALD518, is designed to block the pro-inflammatory cytokine IL-6 and has completed a Phase 2b clinical trial. For more information, please visit http://www.alderbio.com.
SOURCE: Alder Biopharmaceuticals
Post Views: 147
Single IV Dose of ALD403 Demonstrates Efficacy Over Six Months for the Preventive Treatment of Migraine
BOTHELL, WA, USA I May 15, 2015 I Alder BioPharmaceuticals, Inc. (“Alder”) (ALDR), a clinical-stage biopharmaceutical company developing monoclonal antibody therapeutics for the treatment of migraine, announced that six-month follow-up data from its Phase 2 proof-of-concept clinical trial of ALD403, its anti-calcitonin gene-related peptide (CGRP) antibody for the prevention of frequent episodic migraine, were presented today by Jeffrey T.L. Smith, M.D., FRCP, Senior Vice President, Translational Medicine at Alder, in an oral presentation at the 17th Congress of the International Headache Society in Valencia, Spain.
Key Points from Oral Session: Migraine Pathophysiology and CGRP as a Therapeutic Target:
- A single intravenous dose of ALD403 1000mg demonstrated prolonged efficacy over six months for the preventive treatment of migraine.
- Over three months, the proportion of patients with a 50%, 75%, and 100% reduction in migraine days for ALD403 and placebo was 61% vs 33% (p < 0.001); 33% vs 9% (p < 0.001); and 16% vs 0% (p < 0.001), respectively.
- Over six months, the proportion of patients with a 50%, 75%, and 100% reduction in migraine days for ALD403 and placebo was 53% vs 28% (p < 0.001); 26% vs 7% (p < 0.002); and 11% vs 0% (p <0.002), respectively.
- ALD403 was well tolerated and there were no differences from placebo in terms of adverse events or laboratory safety data.
- The migraine prevention proof-of-concept trial was conducted in 163 patients with frequent episodic migraine who had on average nine headache days per month. Patients were given a single intravenous dose of 1000mg of ALD403 or placebo. The primary endpoint was the mean change in migraine headache days from baseline to weeks 5-8, and patients were followed for 24 weeks for additional safety and efficacy analyses.
Alder also presented a poster with Phase 1 data for ALD403 titled, “A Single Dose Placebo-Controlled, Randomized, Ascending Dose Study of ALD403, a Humanized Anti-Calcitonin Gene-Related Peptide Monoclonal Antibody Administered IV or SC — Pharmacokinetic and Pharmacodynamic Results.”
ALD403 is Alder’s transformative novel monoclonal antibody that targets CGRP for prevention of migraine. CGRP is a small protein involved in the transmission of and heightened sensitivity to pain experienced in migraine.
Quote:
Randall C. Schatzman, Ph.D., President and Chief Executive Officer of Alder, said, “We believe that ALD403 has the potential to transform migraine prevention. These data presented today demonstrate the durable efficacy of ALD403 over six months, and we are now focused on identifying the optimal once-quarterly dose of ALD403 for both infusion and self-administration formulations. To this end, we plan to initiate two additional dose-ranging clinical trials in the second half of this year. We believe that providing patients and physicians the choice between these two routes of administration will allow a customized treatment paradigm that best suits each individual patient’s preference and circumstances.”
About Alder BioPharmaceuticals
Alder BioPharmaceuticals, Inc. is a clinical-stage biopharmaceutical company that discovers, develops and seeks to commercialize therapeutic antibodies with the potential to meaningfully transform current treatment paradigms. Alder’s lead clinical candidate, ALD403, inhibits a well-validated molecule shown to trigger migraine attacks, calcitonin gene-related peptide (CGRP), and is currently undergoing Phase 2b clinical testing for the treatment of chronic migraines. Alder plans to initiate additional advanced clinical studies for ALD403 in frequent episodic and chronic migraines in the second half of 2015. Alder’s second program, ALD1613, which targets adrenocorticotropic hormone (ACTH) is undergoing Investigational New Drug (IND)-enabling preclinical studies with the initiation of clinical studies in Cushing’s disease planned for 2016. Finally, clazakizumab, previously known as ALD518, is designed to block the pro-inflammatory cytokine IL-6 and has completed a Phase 2b clinical trial. For more information, please visit http://www.alderbio.com.
SOURCE: Alder Biopharmaceuticals
Post Views: 147
