Numerous Anticipated Clinical Milestones
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 transformative monoclonal antibody targeted to calcitonin gene-related peptide, or CGRP, for migraine prevention. CGRP is a small protein involved in the transmission of and heightened sensitivity to pain experienced in migraine.
Migraine is a significant cause of disability worldwide, generally affecting individuals between the ages of 20 and 50, which are peak productive years. The Migraine Research Foundation estimates U.S. employers lose more than USD$13 billion each year as a result of 113 million lost workdays due to migraine. A preventive therapy for these patients is a critical unmet medical need, as they have few therapeutic options.
Data from clinical trials of ALD403 show that approximately one third of patients achieved 100 percent reduction of their migraines in any given month. In addition, ALD403 showed rapid onset of action with long-lasting efficacy. These positive results, plus the convenience of two modes of administration, give ALD403 the potential to be the therapeutic antibody of choice for preventing migraines.
- 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. These 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 in May 2015, we presented positive six-month follow-up data from our Phase 2 proof-of concept clinical trial. The data show that a single IV dose of ALD403 demonstrated continued efficacy over six months for the preventive treatment of migraine; 11 percent of patients were migraine-free for the entire six-month follow-up period. View the poster.
- Top-line 12-week data from our Phase 2b quarterly infusion formulation trial for the treatment of patients suffering 15 migraine days or more per month, or chronic migraine, is anticipated by the first quarter of 2016.
- We have initiated the first of two planned pivotal trials, PROMISE 1 (PRevention Of Migraine via Intravenous ALD403 Safety and Efficacy 1), a 600-patient double-blind, randomized, placebo-controlled, multi-dose trial. We will study three dose levels of ALD403 and placebo administered quarterly with 150 frequent episodic migraine patients per group. In 2016, we plan to initiate the second pivotal trial, PROMISE 2, a 450-patient double-blind, randomized, placebo-controlled, multi-dose trial. We will study two dose levels of ALD403 and placebo administered quarterly with 150 chronic migraine patients per group. The primary endpoint for both trials is the change in migraine days between ALD403 and placebo as determined by the difference in responder rates over a 12-week period. Read the press release
- We have initiated a Phase 1 study in healthy volunteers to investigate quarterly self-administration dosing of ALD403. Following the top-line data announcement of this study by the first quarter of 2016, 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.
Clazakizumab is a novel monoclonal antibody that inhibits the pro-inflammatory cytokine interleukin-6, or IL-6, and is currently in development for the treatment of 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 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.
ALD1613 is a genetically engineered monoclonal antibody that is designed to specifically inhibit Adrenocorticotropic Hormone (ACTH) and is being developed for the treatment of two orphan diseases: Cushing’s disease and Congenital Adrenal Hyperplasia (CAH). We believe that a novel, mechanism-based approach to address adrenocorticotropic hormone (ACTH)-driven diseases 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 Phase 1 trials in 2016.