The technology platform Gate2Brain, member of CATALONIA.HEALTH, has received the Orphan Drug Designation (ODD) from the European Medicines Agency (EMA) for its innovative product, G2B-002.
The EMA’s orphan designation for G2B-002 represents a decisive step in developing new therapies for complex pediatric cancers, especially those affecting the brain. Gate2Brain’s proprietary technology facilitates high-precision drug delivery across the blood-brain barrier (BHE) with high precision, enhancing both the effectiveness and safety of brain tumor treatment.
Gate2Brain aims to leverage EMA recognition to advance G2B-002 to clinical trials and pave the way for a new era of treatment options in a high unmet need area. “We are moving toward clinical trials that could transform the treatment of pediatric brain tumors,” says Meritxell Teixidó, CEO of Gate2Brain, highlighting the firm commitment of the company to pediatric patients and their families.
This designation recognizes G2B-002 as a potential treatment for a rare and severe disease. It is granted to drugs aimed at conditions affecting fewer than 5 in 10,000 people in the European Union, and which offer significant advantages over limited or non-existent alternatives.
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