DUBLIN, Ireland, April 23, 2013 (GLOBE NEWSWIRE) -- Prothena Corporation plc (Nasdaq:PRTA), a clinical stage biotechnology company focused on the discovery and development of novel antibodies for the potential treatment of a broad range of diseases, today announced the successful first patient dosing in a Phase 1 clinical trial of its antibody therapeutic candidate, NEOD001. The study will evaluate the safety and tolerability of NEOD001 in patients with AL amyloidosis.
NEOD001 is a monoclonal antibody that targets AL and AA amyloid for the potential treatment of amyloidoses, diseases in which misfolded proteins accumulate in the body's organs, causing progressive damage to affected organs and untimely death in many patients.
"We are pleased to initiate this Phase 1 clinical trial for NEOD001 and advance our research pipeline into the clinic," said Dale Schenk, PhD, President and Chief Executive Officer of Prothena. "Our preclinical experience to date with NEOD001 has indicated its potential in this disease area, where limited treatment options exist for patients suffering with amyloidosis. If proven to be safe and effective in clinical trials, our approach has the potential to provide a novel therapy for this orphan disease with significant unmet medical need."In 2012, NEOD001 was granted orphan drug designation for both AL and AA amyloidoses by the U.S. Food and Drug Administration (FDA), and in 2013, NEOD001 was granted orphan designation by the European Medicines Agency for the treatment of AL amyloidosis, the most common form of systemic amyloidosis. There are no currently approved treatments for AL amyloidosis that directly target the potentially toxic forms of the misfolded AL protein. Today, patients are typically treated by attempting to reduce the source of the amyloid-causing proteins. "Our goal with NEOD001 is to provide an improved therapy for patients with amyloidoses, and this is an important milestone for both patients and Prothena," said Gene Kinney, PhD, Chief Scientific Officer and Head of Research and Development of Prothena. "The orphan drug designations we have received in the U.S. and EU recognize the rarity of this disease and will help us advance the development of our potential treatment for these patients."