The purpose of this study is to provide the Company with essential information regarding the natural progression of the disease, as well as the feasibility and variability of potential Phase III clinical endpoints. Patients enrolled in the study will not be receiving treatment but will undergo regular laboratory and clinical assessments. A NHP program is in line with regulatory expectations and the resulting data are important when the Company designs its clinical development program. Vivendy’s potential treatment for Morbus Morquio was recently granted Orphan Drug designation by the Food and Drug Administration (FDA).
"We are pleased with the enthusiasm with which clinicians and patients have joined our NHP program” stated Gertrud Thormann-Huber, Ph.D. Clinical Director, “we believe that the outcome of this study will provide important data that will allow us to optimize our development program.”
About Vivendy Therapeutics Ltd.
Vivendy Therapeutics Ltd., a pharmaceutical company developing an enzyme replacement therapy (ERT) for Mucopolysaccharidosis (MPS) IVA (Morbus Morquio) was founded in March 2006, as a spin-off of Inotech Biotechnologies AG. The company's mission is the development of an enzyme replacement therapy (ERT) for Morbus Morquio. In June, 2008, Saint Louis University (SLU), Office of Innovation and Intellectual Property, St. Louis, Missouri, USA and Vivendy Therapeutics Ltd., finalized and signed a License Agreement where SLU granted to Vivendy Therapeutics the exclusive license to use its patents for the research, development, manufacturing, marketing, sales and other use of the licensed products in the field of Enzyme Replacement Therapy (ERT) compositions intended for the treatment of patients having MPS IVA (Morbus Morquio). For more information please visit www.vivendy.ch
