A biological drug candidate based on allogeneic stem cells, used in intravenous injection. Intended for the treatment of atopic dermatitis in dogs.
The second stem cell-based biopharmaceutical for veterinary use developed by Bioceltix, classified as a somatic cell therapy product, is currently in the stage of safety studies (TAS, Target Animal Safety). The active substance of the drug is a suspension of live allogeneic mesenchymal stem cells obtained from adipose tissue. Because of a different route of administration (into the bloodstream), the medicinal product will differ from the other products by the concentration of cells in a single dose and by the composition of excipients.
BCX-CM-AD will be a biological suspension of live allogeneic mesenchymal stem cells free of microbial contamination, administered by intravenous drip infusion. Treatment with the use of allogeneic mesenchymal stem cells administered directly into the bloodstream may find its applications in the treatment of autoimmune disorders. In the first place, we are focusing on demonstrating its safety and efficacy in the treatment of atopic dermatitis in dogs. BCX-CM-AD will be intended to be administered only by a veterinarian and available off the shelf in the deep-frozen form, ready to be administered by drip infusion immediately after thawing.
The therapeutic effect is based on the immunomodulatory properties of mesenchymal stem cells. Through intercellular signalling, MSCs interact directly with immune system cells. In this manner, they restore immune tolerance, inhibiting chronic inflammation associated with atopic dermatitis in dogs.
Atopic dermatitis (AD) in dogs is a skin disease with a complex etiopathogenesis. The most frequently specified causes are genetic predisposition, increased susceptibility to allergic reactions, exposure to chemicals, environmental pollution, disorders of the healthy microbial flora present on the skin etc. Atopic dermatitis is progressive, chronic and relapsing, and the phase with obvious symptoms (redness, itching, visible skin lesions, effusions, local infections, pain of variable severity, etc.) is usually the phase when the disorder is difficult to treat. Treatment of AD is usually focused only on symptomatic relief. Atopic dermatitis is estimated to affect approximately 15% of the dog population.
The currently available therapies do not resolve the issue of atopy. Why? The treatment of AD is frequently based on elimination of allergens, which often proves very difficult. In such cases, symptomatic treatment is used. Symptomatic treatment includes the administration of antihistamines, corticosteroids or immunosuppressants which may cause excessive down-regulation of the immune system, which often leads to secondary infections, e.g. mycoses. Moreover, anti-inflammatory drugs do not guarantee durability of treatment effects and their prolonged use carries an increased risk of side effects.
Pharmaceutical product candidates