Multiple sclerosis (MS) affects the brain and spinal cord. Early symptoms of MS include weakness, tingling, numbness, and blurred vision. Other possible warning signs are muscle stiffness, thinking problems, and urinary problems. An MS diagnosis is made by the history of symptoms and a neurological exam, often with the help of tests such as an MRI or a spinal tap. No one’s sure what causes MS, but it may be hereditary. There are currently no cures for MS, but treatment can relieve worsening of symptoms.
Synthetic Biologics is developing Trimesta (oral estriol), an investigational oral drug, for the treatment of relapsing-remitting MS. Estriol is a hormone produced during pregnancy that has been scientifically documented to reduce symptoms in women suffering from certain autoimmune diseases, including MS. More than 2.3 million people worldwide (approximately 400,000 in the U.S.) are afflicted with MS, with two to three times as many women affected as men. The lead principal investigator of an investigator-initiated, randomized, double-blind, placebo-controlled Phase II clinical trial conducted at 16 centers in the United States, reported positive topline data at the American Academy of Neurology Annual Meeting in April 2014.
Synthetic Biologics is also developing Trimesta (oral estriol) for the treatment of cognitive dysfunction in female MS patients. Of the 400,000 MS patients in the U.S., approximately 50% will be affected by cognitive dysfunction. Despite the fact that cognitive dysfunction is a primary source of work related disability in MS, there remains no treatment to target this disability. A randomized double-blind, placebo-controlled Phase II clinical trial is currently underway at four clinical sites in the United States, with the University of California, Los Angeles as the lead site.