Traumatic brain injury

TBI – significant medical needs and high societal costs
Traumatic brain injury (TBI) is a leading cause of death and long-term disability in both young people and adults. These conditions are often caused by falls, traffic accidents or violence, and affect more than 60 million people globally each year. TBI is characterised by an initial injury followed by a secondary cascade of inflammation and cell damage. However, despite decades of research, there are currently no approved drugs that can limit the secondary brain damage. Edvince is developing the drug candidates to target the central MEK/ERK1/2 signalling pathway, which is activated in connection with traumatic oxygen deprivation (hypoxia). Intravenous administration achieves high local efficacy and the potential for early intervention. The aim is to improve functional outcome and reduce longterm care needs – in an indication where there is a considerable socio-economic burden.

TBI demonstrates similarities with stroke, yet it is considered a separate specialist area with different market players
TBI has several similarities with stroke in terms of illness progression and neurological damage, but from a clinical and commercial perspective it is considered a separate specialist area, with different players, partners and regulatory conditions. With this in mind, Edvince is planning to build up the TBI subsidiary as an independent entity, with the aim of realising its full value in dialogue with parties that focus specifically on traumatic brain injury. These players are not normally active in the field of stroke, rather they focus exclusively on TBI. Despite the structural difference, TBI and stroke share many underlying disease mechanisms – most notably the development of ischemic damage in the brain (cell death caused by oxygen deprivation) after the initial trauma. In preclinical studies, Edvince has shown that the inhibition of the MEK/ERK1/2 signalling pathwayhas the potential to reduce long-term brain damage following a traumatic brain injury. TBIs often occur in connection with work-related accidents, falls and traffic accidents, but are also common among soldiers in combat – for example, as a result of blast injuries. As part of its strategy, the Company is therefore also developing the drug for emergency treatment in armed forces-related applications. One likely scenario is that, at a later stage, the TBI subsidiary will be distributed to shareholders and listed separately, as part of the long-term commercialisation efforts. Such a structure offers the potential for clearer partner dialogues and can constitute an attractive platform for further development, collaboration or divestment. 

Clinical status
Edvince is working with a research group, which has developed TBI models that can be used in future preclinical development. In the preclinical study, Edvince intends to administer the medication intravenously and to test the dose level, as well as to measure efficacy, i.e. the prevention of subsequent brain damage caused by oxygen deprivation (DCI).