Therapeutic area

Edvince – a paradigm shift in the treatment of stroke

Despite tremendous research efforts and a large number of clinical trials focused on developing treatments for subarachnoid hemorrhage (SAH), the field's current state remains dismal. There are, at present, no efficient medical treatments nor promising drug candidates for this lethal and disabling condition. A different perspective with a new approach is therefore desperately needed.

Edvince's drug discovery and development is born out of founder and Professor Lars Edvinsson's extensive, fundamental and pioneering research of cerebral circulation, receptor regulation, stroke and migraines. Edvince is currently conducting a clinical trialwith its innovative and disruptive lead drug EDV2209, an orphan drug for the treatment of brain ischemia associated with severe subarachnoid hemorrhage. The drug helps to keep the blood vessels in the brain open, allowing brain cells to receive oxygen and nutrients to prevent brain damage.

Stroke

  • More than 13 million people are hit by stroke every year
  • 1 in 4 people >25 years will have a stroke in their lifetime
  • 2nd most common single cause of death in Europe, with an estimate cost to society of €60 Billion (estimated for 2017)

Subarachnoid hemorrhage (SAH)

  • Life-threatening type of stroke caused by bleeding into the space surrounding the brain
  • SAH represents only 5% of all strokes
  • ~50% short-term mortality rate
  • Many survivors become permanently impaired
  • High cost to society owing to the younger age of those affected (average 52 years)
  • High costs per patient: €344,000

Background

More than 13 million people are hit by stroke each year. Globally, one in four people over the age of 25 will have a stroke in their lifetime. It is the second most common single cause of death in Europe, accounting for about 1 million deaths each year3, and it is the number one cause of disability. Every year, 30,000 people in Sweden suffer a stroke, 10 percent of which are caused by a cerebral hemorrhage which accounts for 50 percent of all stroke deaths. Subarachnoid hemorrhage affects mostly people in mid-life, men and women equally. Stroke causes enormous personal, social, economic, and clinical burdens worldwide. Patients surviving a stroke most often require lengthy hospital stays and rehabilitation as well as subsequent support from the communities for their daily activities. Current therapeutic treatment options are limited, and all attempts to develop efficient drugs have proved unsuccessful.

About Subarachnoid Hemorrhage (SAH)

SAH leads to early brain injury (EBI) that is mediated by effects of transient cerebral ischemia during bleeding plus effects of the subarachnoid blood. Secondary effects of SAH include increased intracranial pressure, destruction of brain tissue by intracerebral hemorrhage, brain shift, and herniation, all of which contribute to the well-known pathology of this disease. Many patients survive these phenomena, but deteriorate days later from delayed cerebral ischemia (DCI), which causes poor outcome or death in up to 30 percent of patients with SAH. DCI is thought to be caused by the combined effects of angiographic vasospasm, arteriolar constriction and thrombosis, cortical spreading ischemia, and processes triggered by EBI. Treatment for DCI includes prophylactic administration of nimodipine, and current neurointensive care. Prompt recognition of DCI and immediate treatment by means of induced hypertension and balloon or pharmacological angioplasty are considered important by many physicians, although the evidence to support such approaches is limited. The incidence of SAH from an intracranial aneurysm affects nine per 100 000 people annually in the US, with approximately 600 000 cases worldwide. SAH comprises only 5 percent of all strokes, but the case fatality is high (40 percent), owing in part to delayed cerebral ischemia (DCI) and neurological deterioration days after the hemorrhage. The cost to society of SAH is greater than that of ischemic stroke owing to the younger average age of those affected (52 years versus 70–80 years). Moreover, many survivors of SAH have permanent neurological, cognitive, or functional deficits and cannot return to work.

The economic burden of SAH

SAH remains a devastating form of stroke that affects people at working age, an otherwise healthy population. It is associated with significant morbidity and premature mortality with a typically protracted hospitalization for survivors that requires specialized care. SAH patients require intensive care unit admission, which is resource-intense and a significant driver of hospital cost. A recent report estimated an average cost per patient of TEUR 344, with 84 percent being from indirect costs. Not unsurprisingly, they found higher costs (THEU 100 TEUR) associated with high-grade SAH and greater disability. These data illustrate the extremely high financial burden of this disease. SAH patients are treated by specialized care practice at the intensive care unit but there is no efficient medicine to prevent the common brain damages following the SAH. The particular market for medical treatment of SAH does not exist due to the lack of medicine. However, the overwhelming economic benefit of an efficient treatment that can reduce healthcare, rehabilitation and societal cost will open a new and highly attractive market.

Key segments in stroke

  • In terms of type, the global stroke treatment market has been classified into ischemic stroke and hemorrhagic stroke. The ischemic stroke segment held a major share of the market in 2018, and the trend is anticipated to continue during the forecast period.
  • Based on drug class, the global market has been segmented into tissue plasminogen activators (tPA), anticoagulants, antiplatelets, anticonvulsants, and others. The tissue plasminogen activators (tPA) segment accounted for most of the market share in 2018.
  • In terms of distribution channel, the global stroke treatment market has been categorized into hospital pharmacies, retail pharmacies, and online pharmacies. The hospital pharmacies segment held a major share of the global market in 2018, and this trend is expected to continue of the period of forecast.
  • The market value and forecasts for each of these segments have been provided from 2017 to 2027. The CAGRs of respective segments have also been provided from 2019 to 2027, considering 2018 as the base year. (Source: Transparency Market Research)