According to Dompé, researchers at the Agostino Gemelli IRCCS University Hospital in Rome, Italy have initiated a Phase 2 trial of Dompé’s intranasal formulation of cenegermin-bkbj, a recombinant human nerve growth factor, in patients with spastic cerebral palsy. Dompé currently markets cenegermin-bkbj as Oxervate ophthalmic solution for the treatment of neurotrophic keratitis.
The company says that the study is expected to enroll 60 spastic CP patients aged 2 – 6 years old and is designed to evaluate safety and efficacy of the nasal formulation, specifically “in daily functioning, quality of life, motor abilities, and neurodevelopmental measures.”
Dompé Chief Scientific Officer Marcello Allegretti commented, “Cerebral palsy is a devastating disease, and for patients and families there are still no proven treatments beyond supportive care. With our emerging intranasal NGF platform, we hope to deliver a treatment that goes beyond managing symptoms and changes the course of disease, opening the door to a better future for patients and their families”.
Chief Development Officer Ahmed Enayetallah said, “The cause of CP-related disability is directly connected to NGF’s natural role in the body, supporting the growth, survival, and repair of developing nerve cells. With intranasal NGF, Dompé aims to address CP at its source, fundamentally reshape the disease’s trajectory and improve the life-long outlook for patients.”
Read the Dompé press release
