Israeli biopharmaceutical company Aspireo Pharmaceuticals' acromegaly treatment, Somatoprim, has gained a positive opinion from the Committee for Orphan Medicinal Products (COMP) at the European Medicines Agency (EMA).
If the EMA grants the orphan drug status, Aspireo will gain ten years of marketing exclusivity for Somatoprim in the European Union, and reduced regulatory fees.
Aspireo CEO Carsten Dehning said the agency's recommendation is a key milestone in the drug's development.
"By this resolution, EMA recognises 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," Dehning said.
"The ongoing clinical Phase Ib and Phase IIa studies are expected to support the claim that Somatoprim offers an effective and safe treatment for acromegaly patients."
The proprietary somatostatin analog (SSA) is based on a novel amino acid composition, which demonstrated a distinctive receptor binding and pharmacological profile.
Somatoprim has demonstrated reduced adverse effects on the gastrointestinal tract and glucose metabolism, thereby achieving improved side effect profile compared to current SSA therapies.
When the growth hormone secretion was assessed in cultured human somatotroph adenoma tissue treated with Somatoprim, the increased response rate of acromegalic patients to SSA therapy was observed.
At present Somatoprim is in Phase I/II of clinical development, while Phase Ib and Phase IIa studies are being conducted in Switzerland and the Ukraine respectively.