Current Stage of Development
Our pipeline includes three internally discovered humanized monoclonal antibodies (including one preclinical monoclonal antibody), as well as preclinical programs targeting additional indications that are in the discovery phase.
ALD403 is our novel monoclonal antibody targeted to calcitonin gene-related peptide, or CGRP, for migraine prevention. CGRP is a validated target that is believed to play a key role in migraine. Approximately 36 million Americans suffer from migraines; however, only 22.3 million migraine sufferers have been clinically diagnosed. Migraine is a significant cause of disability, generally affecting individuals between the ages of 20 and 50, which are prime working years.
The Migraine Research Foundation estimates U.S. employers lose more than $13 billion each year as a result of 113 million lost workdays due to migraine. We believe the area of critical unmet need in migraine is preventive therapy with improved efficacy and tolerability to treat patients who have five or more migraine days per month. For the 12.6 million U.S. migraine patients who are candidates for migraine prevention, there are few therapeutic options to manage their disease. We believe this group of migraine patients is highly motivated to seek new treatments due to the limited success of current therapies.
- We have completed a double blind, randomized, placebo-controlled proof-of-concept trial of ALD403 in patients suffering from 5 to 14 migraine days per month, or high frequency migraine. Positive results were presented at the 56th Annual Scientific Meeting of the American Headache Society in June 2014 and at the American Academy of Neurology (AAN) Annual Meeting in May 2014. View the trial results or read the press release.
- At the 17th Congress of the International Headache Society, we will present pharmacokinetic and pharmacodynamic results from: A Single Dose Placebo-Controlled, Randomized, Ascending Dose Study of ALD403, a Humanized Anti-Calcitonin Gene-Related Peptide Monoclonal Antibody Administered IV or SC. Results will be presented during the Migraine Preventative Therapy Poster Session. View the poster.
- Primary end-point data from our Phase 2b intravenous (IV) trial for the treatment of chronic migraine sufferers is anticipated in the second half of 2015 as is the initiation of a pivotal study for both chronic and high-frequency episodic migraines.
- We have initiated a Phase1 study in healthy volunteers to investigate self-administered dosing of ALD403 on a once-per-quarter basis. Following the topline data announcement of this study in the second half of 2015, we plan to initiate a Phase 2b follow-on study to determine optimal dosing for efficacy over a 12-week period for frequent episodic migraine patients.
At the end of 2015 Alder will have three ongoing large clinical trials of ALD403 aimed at treating more than 1500 migraine patients.
Clazakizumab is a novel monoclonal antibody that inhibits the pro-inflammatory cytokine interleukin-6, or IL-6, and is currently in development for both rheumatoid arthritis (RA) and psoriatic arthritis (PsA).
RA is a chronic inflammatory disorder that principally attacks joints. Approximately 2.4 million patients, predominantly women, suffer from RA in the United States. Uncontrolled RA is also associated with substantial morbidity and mortality. There is increasing recognition that treating patients aggressively and early in the course of their disease delays irreversible structural damage to joints. We estimate that global sales of the RA therapies was more than USD $12 billion in 2012 and will grow to $15 billion by 2016. The RA market is currently dominated by a class of drugs that targets tumor necrosis factor alpha, or anti-TNFs. Nevertheless, anti-TNFs are associated with low rates of disease remission and the response to these agents is not typically durable. The American College of Rheumatology has recommended that treatment of RA should be directed at achieving remission in patients or low disease activity if remission cannot be achieved.
Clazakizumab achieved the primary endpoint in a recently completed follow-on Phase 2b, dose-ranging clinical trial designed to determine the safety and efficacy in moderate to severe RA patients who are anti-TNF inadequate responders. We plan to present the full data at a future rheumatology society meeting.
ALD1613 is a novel monoclonal antibody that inhibits Adrenocorticotropic Hormone (ACTH) and is being developed for the treatment of Cushing’s Disease. This disease is driven by long-term exposure to cortisol as a result of increased expression of ACTH produced by a pituitary tumor. We believe that a novel, mechanism-based approach to address Cushing’s Disease using a monoclonal antibody targeted to ACTH that diminishes the overproduction of cortisol with a sound safety profile would provide a significant advantage over the current standard of care and provide an important new therapeutic option to both patients and physicians.
We plan to advance ALD1613 through Investigational New Drug (IND) enabling toxicology studies in 2015 and commence a Phase 1 trial in 2016 for the treatment of Cushing’s Disease.