European Medicines Agency's (EMA) Committee for Orphan Medicinal Products has announced positive opinion for granting orphan disease designation to Aspireo Pharmaceuticals' Somatoprim for the treatment of acromegaly.
Somatoprim, the somatostatin analog (SSA) based on a novel amino acid composition, demonstrated significant receptor binding and pharmacological profile compared to currently marketed SSAs.
Aspireo CEO Carsten Dehning said, "By this resolution, EMA recognizes the potential of Somatoprim to offer significant medical benefit over existing treatments for acromegaly and it supports our efforts to provide valuable treatment alternatives for the many patients that could benefit from it."
The ongoing clinical phase 1b and phase 2a studies in Switzerland and Ukraine respectively, are believed to support the efficacy and safety profile of the candidate in acromegaly patients.
Upon European Commission granting the orphan medicinal product status to the acromegaly therapeutic, Aspireo will gain ten years of marketing exclusivity in the European Union besides winning the advantage of reduced regulatory fees.