A paradigm shift in the prevention of delayed cerebral ischemia (DCI) – Preserving the brain function in diseases and trauma affecting the brain

A paradigm shift in stroke and brain injuries

Edvince AB is a Swedish pharmaceutical development company operating a differentiated platform for the vascular treatment of acute neurological conditions. With a strong clinical efficacy signal in the Phase 2a trial, a preclinically validated mechanism of action and a scalable business model, Edvince has established a portfolio that supports development within three main therapeutic areas – subarachnoid haemorrhage (SAH), focal ischaemia (FI), and global ischaemia (GI).

  • At present, there is no effective treatment for the brain damage resulting from SAH, FI, and GI. The damage includes severe motor and cognitive impairment.
  • The global incidence of subarachnoid haemorrhage (SAH) is approximately 6.1 per 100,000 people per year or 8.3 per 100,000 people per year.
  • Globally, the incidence of stroke is estimated at approximately 11.9 million new cases per year, or approximately 141.6 per 100,000 people per year globally.
  • Approximately 80% of patients suffer global cerebral ischaemia/anoxic brain injury following cardiac arrest associated with myocardial infarction.

    An academic research paper, published a few years ago, highlighted the fundamental problem of developing new drugs for stroke – an area that has long remained a scientific and commercial challenge. In the 20 years preceding the publication, around 430 potentially promising drug candidates had been developed:
  • Approximately 70% of these projects were discontinued
  • 17% were still in the preclinical phase
  • 9% were undergoing various clinical trials
  • Only 4% had reached the market

Despite investments running into the billions and decades of research, clinical successes remain extremely limited. According to research carried out by Edvince’s scientific team, this is not primarily due to a lack of resources or shortcomings in drug design – but rather to an incomplete understanding of the biological mechanisms that cause brain damage following stroke and other acute neurological events.

Edvince’s researchers have not only identified and mapped these damage processes but have also developed a drug candidate that actively counteracts them, which in clinical trials has shown a strong clinical signal of efficacy, resulting in reduced brain damage. For the first time, there is therefore the potential to break the long-standing deadlock in stroke care and give patients the opportunity for better recovery.

An effective medicine, based on these scientific findings and supported by successful clinical development, would represent a decisive breakthrough in how stroke is understood and treated – with results that have not previously been possible to achieve.

Based on pioneering
research on cerebral
circulation

The business is based on many decades of research regarding the regulation of cerebral circulation and vascular signalling, led by Professor Lars Edvinsson. This work has gradually revealed how the biological behaviour of blood vessels changes after a stroke or cerebral haemorrhage – not only due to the acute oxygen deprivation, but also as a result of a large number of molecular events that are set in motion after the initial damage. At the heart of this process is the MEK/ERK1/2 signalling pathway, a cellular chain reaction (known as a cascade reaction) that is activated by intracranial changes in pressure and reduced blood flow in the brain’s arteries. This signalling leads to an upregulation (increased number) of contractile receptors in the smooth muscle cells in the brain’s blood vessels, causing the vessels to contract – at precisely the time when they should be open to maximise the blood supply to the cells in the brain tissue. In the case of a cerebral haemorrhage, there is an initial local (at the site of the haemorrhage) reaction called a vasospasm.

The subsequent reaction caused by the increased intracranial pressure is something else: a delayed but critical chain reaction that affects the vascular system throughout the brain. This is known as DCI (delayed cerebral ischemia). DCI is not addressed by current treatments but is the factor that leads to major damage to brain cells and is one of the main targets of Edvince’s drug candidates. The highly promising results in a phase 2a clinical trial regarding SAH  supports that early inhibition of the MEK/ERK1/2 signalling pathway prevents the onset of DCI and the secondary vasoconstriction, protects brain cells from oxygen deprivation, thereby improve both patient survival and neurological outcomes, and lowers long-term healthcare costs in society.

Via this new mechanism, targeting DCI, several different ischemic situations can be addressed – thereby establishing Edvince as a leader in next-generation treatments of acute neurological conditions.

Our therapeutic areas

The novel MEK/ERK1/2 mechanism is applicable to secondary brain damage following subarachnoid hemorrhage (SAH), stroke and brain ischemia following myocardial infarction. The company has an initial clinical focus on SAH which will validate the mechanism of action. The company has also initiated work with an IV formulation to address the additional opportunities. With further development of new products the company will be able to develop products specifically for the different opportunities in separate entities.

In order to maximise the efficiency, flexibility and visibility of its values, Edvince’s operations will be organised in 2026 in a Hub & Spoke structure, where the subsidiaries handle the relevant therapeutic areas and the parent company Edvince handles matters such as financing and business development work for the subsidiaries. The business plan therefore outlines the planned Hub&Spoke model.

Each subsidiary will conduct indication-specific drug development, while at the same time the scientific grounds, formulation, manufacturing and regulatory activities are shared between the subsidiaries – creating strong synergies, simplifying parallel development and enhancing the potential for subsequent commercialisation. All of the subsidiaries’ drug candidates are based on inhibiting the MEK/ERK signalling pathway, a key mechanism involved in the occurrence of brain damage due to oxygen deprivation.

Edvince’s business model has been built for flexibility and clear value generation at every stage of development. By combining scientific excellence, an orphan drug strategy, a low cost structure and a broad pipeline with a shared platform, Edvince is well placed to create lasting value for patients, healthcare and investors. As part of its growth strategy, the Company plans to pursue a Nasdaq listing around Q4 2026.

Contact

Medicon Village
223 81 Lund. Sweden
info@edvince.com