The Chiesi Group and UCL (University College London) are collaborating to test a novel melatonin formulation as a brain protective medicine for babies who suffer birth asphyxia.

The collaboration is supported by UCL Business PLC (UCLB), UCL’s wholly owned technology transfer company, who have granted Chiesi access to specific research knowledge developed by Professor Nicola Robertson, a renowned expert in the field of neonatal neuroscience and neuroprotection and Professor Xavier Golay (Head of Brain Repair and Rehabilitation at UCL Institute of Neurology), an expert in the field of physiological MRI and image-based biomarkers.

Chiesi will be responsible for the development of a melatonin formulation suitable for neonatal use and for the subsequent full development of the product including the clinical trial program, while UCL, as part of this collaboration, will be entitled to receive royalties on future sales in addition to other undisclosed payments.

Birth asphyxia is a very serious clinical condition caused by temporary but abrupt interruption of the constant blood flow to the brain around the time of birth. In Europe, US and Australia the incidence of birth asphyxia is 2-3 cases per 1000 births at term; in mid and low resource settings the incidence can be 5-20 times more common. Globally, birth asphyxia is the fifth leading cause of child deaths and there is a significant burden of disability as children mature. In 2010, birth asphyxia was the cause of 2.4% of the Global Burden of Disease and 6.1 million years of life with disability.

We are very excited about the collaboration. Even though therapeutic hypothermia is used in many hospitals, cooling is only partially effective and other medicines are desperately needed to optimally treat birth asphyxia.

Consequences of birth asphyxia include devastating disabilities such as cerebral palsy, cognitive, hearing, language and speech impairments, epilepsy and delay in development. These have serious effects on the individual, the family, society and the economy. The clinical need for novel, safe and effective therapies to optimise brain protection following birth asphyxia is therefore paramount.

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