A biological drug candidate based on allogeneic mesenchymal stem cells, used in intra-articular injection. It is intended for the treatment of arthritis in horses.
In Bioceltix, we are working on a biological drug containing allogeneic mesenchymal stem cells isolated from the adipose tissue of horses. This drug candidate, classified as a somatic cell therapy product, is currently at an advanced stage of scale up of its manufacturing process in pharmaceutical production. The active substance of the drug is a suspension of live allogeneic mesenchymal stem cells.
BCX-EM will be a microbial contamination-free suspension of live allogeneic mesenchymal stem cells for parenteral injection. Its therapeutic indications will include lameness caused by joint inflammation resulting from excessive strain on the musculoskeletal system. It is also planned to extend the use of the medicinal product by the treatment of injuries to the superficial digital flexor tendon (SDFT) and the deep digital flexor tendon (DDFT). The drug will also be used to stimulate regeneration of fractured bone tissue. BCX-EM will be intended to be administered only by a veterinarian, available off the shelf and ready to be administered immediately after thawing.
The action of BCX-EM in the treatment of arthritis in horses is based on immunomodulatory properties of MSCs which, by modulating the inflammatory environment, inhibit intensive proliferation of T- and B-cells and induce regeneration of damaged tissue structures.
In addition to immunomodulatory properties, MSCs also have the ability to induce bone regeneration by accelerating osteoblast proliferation and mineralisation of the newly-formed bone matrix.
Arthritis is estimated to affect 20% or even 30% of the horse population and is manifested as decreased locomotor performance and lameness of the affected animal. In most cases, this is accompanied by degenerative lesions of the joints, where mechanical damage to the cartilage tissue causes an immune response manifested as pain. This is observed particularly in sport horses which have the highest prevalence of arthritis among all utility horses. This is a result of a high strain on joints in the course of training and competitions and usually a short time allowed for regeneration. It should be noted that degenerative joint lesions in horses usually have a severe course. On the other hand, the most common injuries in racehorses and show-jumper horses are injuries to the superficial digital flexor tendon (SDFT) and the deep digital flexor tendon (DDFT).
The structure of the equine musculoskeletal system interferes with the natural processes of tissue regeneration, as it is impossible to immobilise the affected limb for longer time to ensure healing of the ruptured tendon.
The same applies to bone fractures – their regeneration is also considerably impaired by the impossibility to immobilise the broken limb. Therefore, tendon diseases and bone fractures in horses very often result in the animal being euthanised.
There are currently no effective drugs in the market that would ensure complete recovery after a tendon rupture. Treatment of lameness caused by chronic inflammation comes down to the use of mainly steroidal or non-steroidal anti-inflammatory drugs. Surgical tendon repairs guarantee no long-term effects, while the scarring severely impairs the mechanical properties of the tissue.
In the cases of bone fractures, even fixations made with orthopaedic bone screws are insufficient to withstand the large pressures to which the broken limb of the horse is exposed.
Pharmaceutical product candidates