Exploring cannabidiol (CBD) potential in treating newborn brain injuries

José Martínez

Fundación para la Investigación Biomédica del Hospital Clínico San Carlos, Madrid, Spain

Newborn hypoxic-ischemic encephalopathy (NHIE) is a serious disease that affects 1-3/1000 live newborns in developed countries, and causes two million infants die or survive with severe permanent disability each year in the world. It is considered an orphan disease and has very limited treatment options. This project focuses on developing an oral solution of cannabidiol (CBD) to improve the neurological outcomes of affected newborns.

Given that previous studies have shown that CBD is a potent neuroprotectant, this project seeks to translate these findings into clinical practice. The scientists aim to design and formulate a stable oral solution of CBD that ensures absorption in newborns without toxic excipients. They will test the compound on newborn pigs and rats to determine the safety of the oral solution and use it as a guide for the initial dose to be used in human trials. The clinical phase will include two studies: one to determine the safety and pharmacokinetics of three dosage levels in human newborns, and a second one to assess the short-term neurological outcomes of the optimal dose.

This project addresses an urgent need for new treatments for NHIE, a condition that affects many newborns each year. Positive results could lead to broader clinical trials and make CBD treatment accessible to newborns worldwide, potentially reducing the incidence of severe neurodevelopmental impairments and improving the quality of life for affected families.

Safety, pharmacokynetics and short-term effects of oral CBD in hypoxic-ischemic newborns

€488.070.00