Current Stage of Development
ALD518Alder’s lead antibody therapeutic, ALD518, is currently being evaluated in multiple Phase 2 clinical studies. ALD518 is a humanized monoclonal antibody, designed to block a cytokine called interleukin-6 (IL-6), which plays a key role in the inflammatory cascade leading to the inflammation, swelling, pain and joint destruction associated with rheumatoid arthritis (RA). Bristol-Myers Squibb is conducting Phase 2 clinical studies of ALD518 in autoimmune diseases, while Alder is spearheading investigation of the antibody in several cancer-related conditions.
ALD518 may also have relevance in the treatment of cancer through modulating the immune response, which plays a crucial role in the disease. Many tumors overproduce IL-6, which stimulates inflammation-related conditions such as cancer-related fatigue, cachexia (wasting) and anemia. In addition, IL-6 has been linked to cancer-related oral mucositis (OM) and acute-graft-versus-host-disease (aGVHD) following hematopoietic stem cell transplantation (HSCT). Targeting the IL-6 pathway potentially treats these cancer-related conditions.
ALD518 Phase I cancer study (400k PDF)
ALD518 Anemia Study (1.4MB PDF)
ALD518 Lean Body Mass Study (1.6MB PDF)
Migraines affect tens of millions of Americans each year. The condition is usually characterized by debilitating headaches that may be accompanied by nausea and/or sensitivity to light and sound. The more severe subpopulation of migraine sufferers experience six or more attacks per month. Approximately five million people in the U.S. fall into this chronic migraine category.
Previous therapeutic approaches targeting CGRP have centered on traditional pharmacology to alleviate migraine symptoms. However, early generations of these drugs were burdened by safety concerns that ultimately halted development. Alder is pioneering a new treatment strategy with ALD403, which will be given to chronic sufferers on a monthly basis via a subcutaneous injection. The medicine will be present at the time of migraine onset—by far the most successful intervention point for treating migraines. A proof-of-concept clinical study evaluating ALD403 in frequent episodic migraineurs is currently ongoing. For more information, please visit this study's page at clinicaltrials.gov or send an email to the clinical team at Alder Biopharmaceuticals.
ALD306ALD306 is a potent, humanized monoclonal antibody that targets proprotein convertase subtilisin kexin 9 (PCSK9). For cardiovascular patients who have trouble reaching target lipid levels with statins, this therapeutic is a promising alternative.
Elevated levels of low-density lipoprotein cholesterol (LDL-C) are a strong predictor of atherosclerosis and cardiovascular disease. Statins are the current first-line therapy used for high-risk and high-cholesterol patients. However, even with maximum statin doses, many patients do not reach target LDL-C levels. Many of these same patients are unable to tolerate statins due to muscle pain and liver toxicity issues. There are approximately 18 million high-risk or high-cholesterol patients in the United States that would benefit from a novel approach to controlling LDL-C levels.
PCSK9 has been genetically linked to cardiovascular disease. Eliminating this protein in humans has been shown to profoundly alter LDL-C levels in a therapeutically significant way. With ALD306, Alder is pioneering a new treatment strategy by focusing on a highly potent antibody that has been preclinically shown to rapidly and durably reduce cholesterol levels to therapeutically important points.