Worg Pharmaceuticals (Worg), a clinical stage biopharmaceutical company developing new treatments for allergic and autoimmune diseases, announced today that the European Medicines Agency (EMA) has granted Worg product WP1301 Orphan Drug Designation (ODD) for the treatment and prevention of Factor VIII intolerance in Hemophilia A patients.
WP1301 is a synthetic peptide derived from hFVIII capable of binding to an MHC class II molecule without further antigen processing and being recognized by a Factor VIII specific T cell. WP1301 offers a potential first-in-class approach for both the treatment and prevention of Factor VIII intolerance in Hemophilia A patients.
“Orphan Drug Designation by the EMA represents an important step towards development of WP1301 for patients with Hemophilia A,” said Andrew Xu, CEO. “It is encouraging for Worg to continue the research and development with the Apitope® technology platform to find new treatment options for patients with unmet medical need.
Orphan Drug Designation is granted by the EMA to a drug or biologic intended to treat a rare disease or condition with certain incentives such as tax credit for clinical trial expenses, exemption of new drug application fees, reduced fee for EMA scientific advice and a 10-year market exclusivity period after product approval.