Profile: Chelsea Therapeutics International Ltd (CHTP.OQ)
19 Dec 2013
Chelsea Therapeutics International, Ltd., incorporated in April 2002, is a development stage pharmaceutical company that focuses on acquiring, developing and commercializing products for the treatment of a variety of human diseases. The Company is developing a therapeutic agent for the treatment of symptomatic neurogenic orthostatic hypotension (NOH), associated with primary autonomic failure and falls related to NOH in Parkinson’s Disease (PD), as well as other norepinephrine-related conditions and diseases, including intradialytic hypotension (IDH), fibromyalgia, adult attention deficit hyperactivity disorder (ADHD), chronic fatigue syndrome (CFS), freezing of gait in PD and Down syndrome. In addition, the Company is developing a portfolio of metabolically inert antifolates for the treatment of rheumatoid arthritis and is exploring potential applications in multiple other autoimmune disorders.
Droxidopa, the Company’s advanced investigational product candidate, is an orally active synthetic precursor of norepinephrine. It is being developed for the treatment of symptomatic NOH in primary autonomic failure, a group of diseases that includes PD, multiple systems atrophy (MSA), and pure autonomic failure (PAF). Droxidopa is a synthetic amino acid, is converted by the body into norepinephrine and, as a prodrug of norepinephrine, provides replacement therapy for norepinephrine deficiency. Droxidopa is approved and marketed by Dainippon Sumitomo Pharma Co., Ltd. (DSP), in Japan for the treatment of symptomatic orthostatic hypotension, freezing of gait in PD and IDH. The Company is focusing on the clinical development of droxidopa in symptomatic NOH, the prevention of falls related to NOH in PD, the treatment of fibromyalgia and IDH. Study 301 and Study 302 were designed to compare Northera to placebo at multiple sites in North America, Europe and Australia.
Midodrine is the food and drug administration (FDA) approved therapeutic for the treatment of orthostatic hypotension. Fludrocortisone is also widely used in the treatment of orthostatic hypotension although this specific indication has not been approved by the FDA. Fludrocortisone is a synthetic adrenocortical steroid possessing potent mineralocorticoid properties and high glucocorticoid activity.
Metabolically Inert Antifolates
The Company’s portfolio of antifolate compounds is a library of orally available and metabolically inert antifolate compounds with potent autoimmune, anti-inflammatory and anti-tumor properties. These compounds are engineered to treat a range of immunological disorders with less harmful and unpleasant side effects than those typically associated with classical antifolates, such as methotrexate (MTX), the antifolate treatment and standard of care for a range of abnormal cell proliferation diseases. Drug candidates from this portfolio, including both clinical candidates CH-1504 and CH-4051, inhibit dihydrofolate reductase, an enzyme required for cell proliferation.
The Company’s portfolio of drug candidates includes multiple molecules for the treatment of various autoimmune/inflammatory diseases. The advanced platform is a portfolio of metabolically-inert antifolate molecules engineered to have potent anti-inflammatory and anti-tumor activity to treat a range of immunological disorders, including two clinical stage product candidates designated as CH-1504 and CH-4051. CH-1504 has completed Phase II trials in rheumatoid arthritis.
I-3D portfolio is a group of orally active compounds that inhibit the enzyme dihydroorotate dehydrogenase (DHODH) for the treatment of autoimmune diseases and transplant rejection. In addition to therapeutic applications in rheumatoid arthritis, compounds from the I-3D portfolio have clinical application in immune-mediated inflammatory disorders, including transplant rejection, psoriasis and systemic lupus erythematosus.
Chelsea Therapeutics International Ltd
Suite 200, 3530 Toringdon Way
CHARLOTTE NC 28277