BCX-CM-AD

A candidate drug based on allogeneic stem cells, administered by intravenous injection. The product is intended for the treatment of atopic dermatitis in dogs. The active substance of the drug is a suspension of live allogeneic mesenchymal stem cells derived from adipose tissue. The therapeutic effect is based on the immunomodulatory properties of mesenchymal stem cells, which interact directly with immune system cells through intercellular signaling. This restores immune tolerance and suppresses the chronic inflammation associated with atopic dermatitis in dogs.

Disease

Atopic dermatitis (AD) in dogs is a complex skin disease with multifactorial pathogenesis. Common causes include genetic predisposition, increased susceptibility to allergic reactions, exposure to chemicals, environmental pollution, and disturbances in the healthy microbial flora present on the skin. AD is progressive, chronic, and recurrent, and the phase with pronounced symptoms (redness, itching, visible skin lesions, exudates, localized infections, pain of varying intensity, etc.) is often so advanced that it becomes difficult to treat. Treatment of AD usually focuses solely on alleviating symptoms. It is estimated that approximately 15% of the dog population suffers from atopic dermatitis.

Existing treatment

Currently available therapies do not solve the problem of atopy because they mainly focus on eliminating allergens that cause the allergic reaction, which can be very difficult. Therefore, symptomatic treatment is primarily used, involving the administration of antihistamines, corticosteroids, or immunosuppressive drugs. These medications can excessively suppress the immune system, which often leads to secondary infections, such as fungal infections. Furthermore, the use of anti-inflammatory drugs does not provide long-lasting effects, and their chronic use increases the risk of side effects.

Product	Species	Condition	Route of  adminitration	Target Animal Safetyies	Pivotal study	Application to EMA	List of questions from EMA
BCX-EM		AD	i.v.			Second indication for BCX-CM-J

Others

BCX-CM-J

An allogeneic stem cell-based medicinal product for the treatment of osteoarthritis in dogs.

BCX-EM

An allogeneic stem cell-based medicinal product developed for the treatment of osteoarthritis in horses.

BCX-CM-Sec

A research project aimed at developing a cell-free biological drug effective in treating atopic dermatitis in dogs.