BCX-EM
BCX-EM
A drug candidate based on allogeneic mesenchymal stem cells, intended for the treatment of joint inflammation in horses. The active substance of the product is a suspension of live allogeneic mesenchymal stem cells derived from adipose tissue. The product is administered via intra-articular injections. The therapeutic indication will include lameness caused by joint inflammation resulting from excessive strain on the musculoskeletal system.
There are also plans to extend the use of the medicinal product to treat injuries of the superficial digital flexor tendon (SDFT) and the deep digital flexor tendon (DDFT) caused by trauma. Another intended application of the drug is to support the regeneration of bone tissue damaged due to fractures.
BCX-EM has the potential to inhibit inflammatory processes at the molecular level and protect articular cartilage, revolutionizing the treatment of joint inflammation in these animals. BCX-EM not only reduces pain and improves mobility in horses but also has the potential to extend their active life and reduce costs associated with long-term treatment.
Disease
It is estimated that up to 30% of the horse population suffers from joint inflammation, which manifests as reduced locomotor performance and lameness. In most cases, this is accompanied by degenerative joint changes, where mechanically damaged cartilage tissue triggers an immune response in the form of pain. This is especially observed in sporting horses, among which the percentage of individuals suffering from joint inflammation is the highest compared to other working horses. This results from the high strain on joints during training and competitions, as well as generally limited time allocated for recovery. Unfortunately, osteoarthritis in horses often has a very severe impact.
Existing treatment
There are currently no effective drugs on the market that allow for full recovery after tendon injuries in limbs. Treatment of lameness caused by chronic inflammation mainly relies on the use of steroidal or non-steroidal anti-inflammatory drugs. Surgical tendon repairs are often not durable, and the resulting scar tissue significantly impairs the mechanical properties of the tissue. In the case of bone fractures, even orthopedic screw fixations are insufficient to withstand the high compressive forces that the fractured limb of a horse is subjected to.
Caregivers are seeking effective and more advanced therapies — a trend also reflected in the veterinary industry. In Europe alone, there are approximately 7 million potential patients.
| Product | Species | Condition | Route of adminitration | Target Animal Safetyies | Pivotal study | Application to EMA | List of questions from EMA |
| BCX-EM |  | OA | i.a. |  | | | |
Others
BCX-CM-J
BCX-CM-AD
