A research report (http://dtn.fm/w6uT3) issued earlier this week by Aegis Capital Corp. shows that Alder Biopharmaceuticals, Inc. (NASDAQ: ALDR) has lived up to its promise since 2004, when it received startup funding from the Army under the Small Business Technology Transfer (STTR) program. Since then the company has been working on the development of new production technologies for humanized antibodies. Now it is close to making the fruits of that research available for the treatment of migraine, inflammatory diseases and autoimmune diseases with its lead product candidate, ALD403. Results of ongoing clinical trials are quite promising.
Trials of ALD403 go by the acronym “Promise”, which stands for PRevention Of Migraine via Intravenous ALD403 Safety and Efficacy. These clinical trials are taking two paths: Promise 1 for the treatment of frequent episodic migraine (FEM) and Promise 2 for the treatment of chronic migraine (CM).
Phase I clinical trials of ALD403 kicked off in May 2012 for the treatment of migraine headaches. In March 2013, in what is now Promise 1, the first patients were dosed with ALD403 in phase II proof-of-concept clinical trials for the treatment of FEM. In October 2015, pivotal trials of ALD403 for FEM were commenced.
Following on from the initial studies on ALD403, phase IIb clinical trials were initiated in November 2014 for the treatment of CM (Promise 2). In March 2016, positive top line data was announced from the Promise 2 phase IIb study in patients with chronic migraine.
Now, Alder is moving ALD403 into phase III trials for both Promise 1 and Promise 2. For Promise 1, the pivotal trials are expected to report results in the first half of 2017, while results for Promise 2 should be ready about one year later, in the first half of 2018.
Migraine is a neurological disorder that is more prevalent than is commonly presumed. According to the Migraine Research Foundation (MRF), the condition affects about 38 million men, women and children, i.e. about 12 percent of the U.S. population. Worldwide, the illness is the third most prevalent and affects some one billion people. The condition is characterized by intense or throbbing pain in the head, commonly accompanied by nausea, vomiting and high sensitivity to light and sound. Over time, patients may be subject to an increasing frequency and severity of migraine attacks, potentially leading to significant disability. The MRF estimates that U.S. employers lose more than $13 billion each year as a result of 113 million lost work days due to migraine.
Currently approved medications for migraine include beta blockers (such as propranolol), topiramate, sodium valproate and botulinum toxin, or Botox. These generally lead to a range of side effects, including cognitive impairment, nausea, fatigue and sleep disturbance. As a result, only about 12 percent of adults with frequent episodic or chronic migraine take preventive medications, according to the U.S. Agency for Healthcare Research and Quality reports. Alder believes this creates a significant unmet medical need for new treatments with improved safety and efficacy that can either prevent migraines completely or reduce the frequency to a level where patients can find adequate relief from existing abortive medications.
For more information, visit www.alderbio.com
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