Interim Report January – September 2018
In traumatic brain injury (TBI), nerve cells are damaged immediately. The injury also continues to exacerbate for several days after the trauma, which often affects the total extent of injury. At present, there are no pharmaceuticals available that can limit the effect of the traumatic injury. TBI patients risk suffering a series of functional disabilities such as cognitive processes, feelings, language, the senses and capability to independently perform activities of daily living. The direct costs of care are estimated at over SEK 70 billion each year.
Researchers at Lund University, including NeuroVive’s CSO, have demonstrated that cyclosporine has powerful neuroprotectant characteristics. By inhibiting cyclophilin and stabilizing the energy-producing mitochondria, cyclosporine is expected to limit the extent of brain injury.
Some three million people are affected by TBI every year in Europe and the United States. The total cost of care for a patient with severe traumatic brain injury is an estimated SEK 5-14 million. Accordingly, TBI represents a significant socioeconomic burden on health care, and there is a huge need for effective therapies. As far as NeuroVive is aware, there is no pharmaceutical currently on the market that can limit spread of injury and improve neurological function of patients post-TBI.
Drug candidate NeuroSTAT® has recently concluded a phase IIa trial at Copenhagen University Hospital at two doses in patients with severe TBI, with safety, pharmacokinetics and brain exposure as primary endpoints.
The results of the CHIC (Copenhagen Head Injury Cyclosporine) study show that appropriate dose-dependent concentration levels can be measured in the blood, and that NeuroSTAT reaches the target, the central nervous system (CNS). No unexpected safety signals were detected. Thus, the primary objective of CHIC to demonstrate safety and elucidate pharmacokinetics of NeuroSTAT at two different dose levels (5 and 10 mg/kg/day) in patients with severe TBI was reached.
A significantly reduced volume of brain injury (35% decrease) after NeuroSTAT treatment was observed in MRI scans in the experimental TBI studies done in collaboration with University of Pennsylvania (Penn). Furthermore, these studies displayed positive changes in brain energy metabolite levels and mitochondrial respiratory function, as well as decreased generation of reactive oxygen species.