CHARLOTTE, N.C., Jan. 28, 2009 -- Chelsea Therapeutics International, Ltd. (Nasdaq:CHTP) has initiated a Phase II trial of Droxidopa, a synthetic precursor of norepinephrine, both alone and in combination with carbidopa for the treatment of Fibromyalgia.
The Phase II trial, being conducted in the U.K., is a multi-centre, randomized, double-blind, placebo-controlled, dose response, factorial 12-arm parallel group study evaluating 120 patients equally randomized to receive Droxidopa monotherapy, carbidopa monotherapy, Droxidopa/carbidopa combination therapy or placebo. Accordingly, 10 patients will be randomized into each of 12 groups to receive: 200mg, 400mg or 600 mg of Droxidopa TID; 25mg or 50mg carbidopa TID; 200/25mg, 400/25mg or 600/25mg Droxidopa/carbidopa TID; 200/50mg, 400/50mg or 600/50mg Droxidopa/carbidopa TID; or placebo over a 9-week treatment period. The primary endpoint will be the average reduction in pain as measured by the Short Form McGill Pain Questionnaire. Secondary outcomes of the study include Fibromyalgia Index Questionnaire (FIQ), Patient Global Impression of change (PGI-C), Multidimensional Fatigue Inventory (MFI), and Hamilton Anxiety Depression survey (HAMA).
"While the underlying cause or causes of FM is not yet fully understood, the increased diagnoses, acceptance and awareness of this complex disorder has generated a substantial body of new research in recent years. Findings from this research continue to underscore the role of the central nervous system and specific neurotransmitters such as norepinephrine as part of the basic mechanisms of Fibromyalgia," said Ernest Choy M.D., the study's lead investigator and Consultant Rheumatologist, GKT School of Medicine, King's College, London. "Previous studies have suggested serotonin-norepinephrine reuptake inhibitors, particularly those with a norepinephrine preference, are active in the treatment of central pain and the management of fibromyalgia. The unique design of this trial should allow us to not only explore the role and potential therapeutic application of norepinephrine in fibromyalgia, but, by pairing droxidopa with carbidopa to limit peripheral metabolism of droxidopa into norepinephrine, should also allow us to more closely examine the central effect of NE in this indication."
About Droxidopa and Fibromyalgia
Fibromyalgia is a chronic and debilitating condition that is characterized by widespread pain and stiffness throughout the body, accompanied by severe fatigue, insomnia and mood symptoms. While the precise etiology of fibromyalgia remains unknown, current research has focused on the role of norepinephrine (NE) reuptake and availability in the central nervous system. NE, a widely used neurotransmitter in the central and peripheral nervous systems has long been linked to both chronic pain and depression. Droxidopa, a synthetic amino acid, is converted by the body into norepinephrine and, as a prodrug of NE, provides replacement therapy for NE deficiency. While NE, as a catecholamine does not penetrate the blood-brain barrier, droxidopa, as a neutral amino acid, is able to do so thus providing both a peripheral and central affect on circulating NE levels.
About Chelsea Therapeutics
Chelsea Therapeutics is a biopharmaceutical development company that acquires and develops innovative products for the treatment of a variety of human diseases. The Company is currently developing a library of metabolically inert antifolate compounds engineered to have potent anti-inflammatory and anti-tumor activity to treat a range of immunological disorders. Early clinical data suggests that Chelsea's lead antifolate compound, CH-1504, is a safe and effective treatment alternative to methotrexate for RA and may have further applications for psoriasis, IBD and certain cancers. Chelsea's antifolate program is complemented by the development of the I-3D portfolio of therapeutics targeting immune-mediated inflammatory disorders and transplantation. In addition to its autoimmune pipeline, Chelsea is developing Droxidopa, an orally active synthetic precursor of norepinephrine, for the treatment of neurogenic orthostatic hypotension. Currently approved and marketed in Japan, Droxidopa has accumulated over 15 years of proven safety and efficacy, historically generating annual revenues of approximately $50 million in Japan.
This press release contains forward-looking statements regarding future events. These statements are just predictions and are subject to risks and uncertainties that could cause the actual events or results to differ materially. These risks and uncertainties include reliance on collaborations and licenses, risks and costs of drug development, regulatory approvals, intellectual property risks, our reliance on our lead drug candidate CH-1504, our history of losses and need to raise more money, competition, market acceptance for our products if any are approved for marketing, reliance on key personnel including specifically Dr. Pedder, management of rapid growth, and the need to acquire or develop additional products.
CONTACT: Chelsea Therapeutics Nick Riehle, Chief Financial Officer 704-973-4201 Investor/Media Relations Kathryn McNeil 718-788-2856