AgoneX Biopharmaceuticals, Inc. is a Delaware clinical stage biopharmaceutical company developing and commercializing safe and effective therapeutics for migraine headaches. The company plans to develop both a product (AGX-201) and an industry unique proprietary technology for the treatment and prevention of migraine headaches.
Migraine is an extraordinarily common neurological disease, affecting 39 million men, women and children in the U.S. and 1 billion worldwide. Migraine is the 3rd most prevalent illness and the 6th most disabling illness in the world. (Source: https://migraineresearchfoundation.org/about-migraine/migraine-facts/). The National Headache Foundation estimates that US businesses lose $50 billion each year because of absenteeism, reduced employee productivity, and medical expenses caused by headaches. (JD Bartleson, Treatment of Migraine Headaches, Mayo Clin. Proc. 1999; 74; 702-708). Neurologists agree that safer and more effective prophylactic agents represent the most critical unmet need in the treatment of both episodic and chronic migraine. According to J.P. Morgan Research, the migraine product market size is estimated to grow to $10B in the coming years.
AgoneX Biopharmaceuticals offers an industry unique solution that addresses the root cause of the problem. Our solution consists of a proprietary technology targeting histamine receptors associated with migraine headaches. Surrogate data from clinical trials using the Histamine Receptor Modulation approach, used in patients that did not respond to FDA approved products, yielded positive results. In contrast, our competitors including CGRP developers are not addressing the root cause of the issue and as a result, CGRPs have an approximately 50% patient response rate. We believe AgoneX Biopharmaceuticals’ technology will prove to be superior to CGRP antibody migraine products at all levels: safety, efficacy and cost. AgoneX Biopharmaceuticals has filed an Investigational New Drug (IND) application with the FDA. The FDA agreed the company can start its development with a Phase II clinical trial; Phase III clinical trial may not be required if our Phase II trial and its results are sufficiently compelling.
AgoneX Biopharmaceuticals, Inc. intends on advancing its industry unique technology in order to provide patients with a safe and effective treatment for migraine headaches. Once the company has successfully developed our migraine product, the company intends to develop its proprietary technology for additional indications such as Parkinson’s disease, Multiple Sclerosis (MS), Chronic Traumatic Encephalopathy (CTE) and Amyotrophic Lateral Sclerosis (ALS). The company has three (3) issued patents in the U.S. and one (1) issued patent in Japan.