The drug candidate ANXV

Annexin A5 is a protein that has been shown capable of protecting and repairing cells and counteract unwanted inflammation. The Company is developing the biological drug candidate ANXV, which is a recombinant human protein, Annexin A5, for the acute intravenous treatment of various cardiovascular diseases.

The background of ANXV

Our blood vessels have in their core a very important cell layer. This layer is called the endothelium and consists of endothelial cells. An adult has up to two trillion endothelial cells. These endothelial cells form the interface layer between the blood and the rest of the blood vessel wall and are exposed to harmful substances throughout their lives, such as rancid fats, microorganisms and stress.

Endothelial damage contributes, among other things, to diseases such as myocardial infarction, stroke, peripheral arterial disease in the legs and more rare conditions such as central retinal vein occlusion (CRVO) or sickle cell disease (SCD).

The body has a natural ability to protect itself against such damage and repair the blood vessels. This is where the protein Annexin A5 is of the utmost importance. Annexin A5 is found in all cells but in greater quantities in the endothelium of our blood vessels and of the heart. Studies show that the decreased ability of the cells to produce Annexin A5 or that the amount of protein is insufficient to repair damaged damage, is directly linked to both aging and disease.

The defense protein Annexin A5 acts on several levels

This protein is considered to be an ancient native defense protein and exhibits several unique properties. In addition to Annexin A5 immediately finding damaged cells, it also:

– builds a shield in the form of a protective layer on the cell surface

– heals the damaged cell membrane

– reduces the inflammation

This way, Annexin A5 has a two-stage effect where it has immediate repairing capabilities but also has a long-term anti-inflammatory effect, especially in our blood vessels and in the heart. This defensive ability is not enough in certain acute vascular conditions and an inability to produce Annexin A5 is linked to both cardiovascular diseases and aging.

By administering Annexin A5 and thereby improving the body’s own ability to protect and repair cells in the vascular system, the Company sees great opportunities to fill a treatment gap where important vascular disease mechanisms are not currently addressed effectively. The Company’s management believes that ANXV has the potential for broad therapeutic areas. Treatment with ANXV is primarily intended for the acute treatment of patients with different types of vascular diseases, including those with major cardiovascular diseases where damage and inflammation of the blood vessels play a decisive role. ANXV is intended for intravenous administration in hospitals. The Company estimates that ANXV has the potential to become a First-in-Class drug for several patient groups where there is a high unmet medical need.

Annexin A5 has been tested for safety and efficacy in several preclinical disease models both in vitro and in vivo, where several studies were carried out by leading researchers independent of the Company.

Studies have shown that low levels of Annexin A5 are directly linked to an increased risk of premature (before age 45) myocardial infarction and that patients with ongoing sickle cell crisis have an insufficient amount of Annexin A5.


The use

The drug candidate ANXV is intended for intravenous administration to patients with acute vascular damages, where a reduced defensive ability is expected and the body’s own Annexin A5 is insufficient due to the depletion of the cells which can no longer produce a sufficient amount of Annexin A5 for the damages. This way it would be possible to improve the body’s own ability to protect and repair the blood vessels, thereby reducing the suffering and hopefully the mortality within several patient groups with both rare vascular diseases and major diseases such as myocardial infarction.

As far as the Company is aware, there are currently no drugs that prevent or repair damages to blood vessels in the same way as Annexin A5. The Company believes that ANXV has the potential to become a First-In-Class drug for several patient groups where there is a high unmet medical need.