SOM BIOTECH OBTAINS THE APPROVAL FROM REGULATORY AUTHORITIES TO CARRY OUT THE PHASE IIA CLINICAL TRIAL FOR TTR AMYLOIDOSIS

posted on July 5, 2014

SOM Biotech has just obtained the approval from the Ethics Committee of Hopital Vall d’Hebron and the Spanish Medicines Agency (AEMPS) to start the Phase IIa clinical trial of its compound SOM0226 indicated for transthyretin Amyloidosis.

This trial will be jointly coordinated by SOM Biotech and Vall d’Hebron Research Institute (VHIR). The principal investigator of the study is the neurologist Dr. Josep Gámez, head of the Peripheral Nervous System Research Group at VHIR and coordinator of the Neuromuscular Disease Unit of the Neurology Department of the hospital.

SOM0226 compound obtained the Orphan Drug Designation by the FDA in 2013 and is indicated for all variants of the disease.

20 patients with the disease will be recruited for the trial and first results are expected by the end of the present year.

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