Current Stage of Development
Our pipeline includes two wholly-owned, internally discovered humanized monoclonal antibodies, as well as preclinical programs targeting additional indications that are in the discovery phase.
ALD403 is our wholly-owned 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 work days 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 five 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.
We recently initiated a Phase 2b intravenous (IV) formulation trial for the treatment of chronic migraine sufferers and data is expected for this trial in the second half of 2015. We also plan to initiate a Phase 2b subcutaneous (SQ) formulation trial for the treatment of frequent episodic migraine sufferers in the first half of 2015.
Clazakizumab is a novel monoclonal antibody that inhibits the pro-inflammatory cytokine interleukin-6, or IL-6.
Positive Phase 2b data was presented at the American College of Rheumatology and European League Against Rheumatism conferences in October 2013 and June 2014, respectively. Data from a study in adults with moderate-to-severe active RA and an inadequate response to methotrexate showed that:
- All clazakizumab treatment arms, both as monotherapy and in combination with methotrexate (MTX), met the primary endpoint of ACR20 response at 12 weeks, compared to MTX alone.
- Clazakizumab had promising rates of low disease activity and remission based on Disease Activity Score (DAS)28, Clinical Disease Activity Index (CDAI) and Simplified Disease Activity Index (SDAI) criteria in the study that included MTX and anti-TNF comparator arms. Remission rates by CDAI and DAS28-CRP were numerically greater for clazakizumab than for the active comparator anti-TNF, adalimumab.
- The safety profile of clazakizumab was consistent with the known pharmacology of IL-6 blockade.
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 early on in the course of their disease delays irreversible structural damage to joints. We estimate that global sales of the RA therapies was more than $12 billion in 2012 and will grow to $15 billion by 2016. The RA market is currently dominated by a class of drugs that target 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. In 2012, the American College of Rheumatology recommended that treatment of RA should be directed at achieving remission in patients or low disease activity if remission cannot be achieved.
The results of a Phase 2b dose-ranging clinical trial of clazakizumab in patients who suffer from PsA was the focus of an oral presentation at the American College of Rheumatology’s 2014 Annual Meeting in November, 2014.