Today, Synthetic Biologics announced that it has completed patient enrollment for a phase 2 clinical trial of the company’s proprietary oral formulation of estriol (Trimesta) for treating relapse-remitting multiple sclerosis. The company has received more than $8 million in external grant funding for this Trimesta clinical trial, so it is anticipated that the trial will be fully funded to its completion.
The multi-center phase 2 clinical trial for relapsing-remitting MS in women has been randomized, double-blind, and placebo-controlled and initially enrolled 164 patients who are being dosed and monitored for two years. Clinical investigators at 15 U.S. locations have been administering either oral Trimesta or matching placebo, as well as glatiramer acetate (Copaxone), which is an FDA-approved MS therapy, to women ages 18-50 who have been recently diagnosed with relapse-remitting MS.
Currently, estimated annual sales of injectable disease-modifying MS therapies are at around $8.9 billion. Various reports estimate that annual sales of oral disease-modifying therapies for MS will exceed $5 billion by 2017. If and when approved, Trimesta would be in that class.
Synthetic Biologics is a biotechnology company specializing in the development of synthetic DNA-based therapeutics and disease-modifying medicines for serious illness. In addition to investigating Trimesta for the treatment of relapse-remitting MS, the company is also in the process of developing, or has partnered development of, product candidates for treating pulmonary arterial hypertension, cognitive dysfunction in MS, fibromyalgia, and amyotrophic lateral sclerosis (ALS).
For more information, visit the company’s Web site at www.syntheticbiologics.com
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