Edvince has successfully used its drug candidate EDV2209 in a phase 2a study. The study was conducted in relation to a very severe form of stroke, subarachnoid haemorrhage (SAH), which is an acute bleeding in the space between the brain and the inner meninges. SAH is caused by a ruptured blood vessel (aneurysm) in the brain. The condition causes sudden, severe splitting headaches, loss of consciousness and can be life-threatening, requiring immediate specialist hospital care. SAH has a very high mortality rate. If the patient survives, it can cause severe subsequent brain damage, which can entail devastating consequences for the affected person and major costs for society. There are currently no effective and approved treatments for SAH.

Edvince made a conscious decision to initiate its clinical development programme regardingfor SAH and has received Orphan Drug Designation in both the USA and Europe for the drug candidate EDV2209. Following approval and subsequent launch, this will mean robust, exclusive market protection for the product in these two major pharmaceutical markets. from market launch. The choice was also based on a strategic assessment that a positive outcome in this patient group would not only provide strong validation of the Company’s drug platform, but also create maximum scientific and regulatory leverage for further development in other stroke indications.

In the recently completed phase 1b/2a study with EDV2209, Edvince has not only demonstrated a strong safety profile with no reported severe side effects related to EDV2209, but also as well as proven strong clinical efficacy signal in phase 2a study, which jointly provide a strong basis for further development.

The results mean that the Company has obtained clinical proof-of-concept – for the mechanism of action (inhibition of the MEK/ERK1/2 signalling pathway), the formulation and the method of administration via intraventricular delivery without any specific side effects. The results indicate a shorter hospital stay and reduced complications/brain damage compared to patients who did not receive the EDV2209 treatment, thus allowing for a successful continuation of the clinical development programme for SAH. Since the same mechanism of action, signalling pathway and substance class are also used for the indications focal ischemic stroke and global cerebral ischemia, the Company now has clearly validated grounds for further development with lower regulatory risk and a shorter pathway to commercialisation. The potential of the platform technology is also confirmed in other indications in preclinical studies that have been carried out. The formulation work for intravenous treatment of the wider stroke indications will be finalised shortly, whereupon clinical studies can be initiated within these indications. This significantly reduces both costs and development time compared to traditional drug development, which normally only applies to a disease indication.