SB-REG-HMILA – innovative ILA-1 biological therapy in veterinary orthopaedics

Product description

SB-REG-HMILA is a veterinary biological product developed by Sanford Biotech as a modern anti-inflammatory therapy based on interleukin-1 inhibitors (ILA-1).

The preparation is an advanced alternative to classic non-steroidal anti-inflammatory drugs (NSAIDs) and steroids, which alleviate symptoms but do not eliminate the causes of chronic joint inflammation.

SB-REG-HMILA is a biological medicinal product (Biologic/vATMP) therapy based on recombinant proteins that block the IL-1 receptor. The product is intended for the treatment of degenerative and inflammatory joint diseases in dogs and horses.

 


Aplication

SB-REG-HMILA is used in animals suffering from:

  • chronic arthritis (osteoarthritis, osteoarthrosis),
  • synovitis,
  • post-traumatic inflammation and swelling,
  • joint pain and limited mobility after exercise or surgery.

In horses, the therapy is used particularly in sports orthopaedics – after tendon, ligament and joint injuries, while in dogs it is used as a support in degenerative diseases of the limbs and hips.


Key benefits

 

  • Direct blocking of the IL-1 inflammatory pathway, the main mediator of inflammation and pain in the joint.
  • Reduction of joint pain and stiffness within a few days of administration.
  • No side effects characteristic of NSAIDs – no strain on the kidneys or liver.
  • Can be combined with MSC and PRP therapy – synergistic effect in joint regeneration.
  • Safe biological therapy – compliant with EMA and VICH GL40 requirements.

How it works

-REG-HMILA zawiera białko nanocząsteczkowe (rekombinowany inhibitor IL-1Ra) o wysokim powinowactwie do receptora IL-1, co uniemożliwia aktywację kaSBskady prozapalnej. 
Mechanizm działania polega na: 

hamowaniu wiązania interleukiny-1 z receptorem IL-1R1, 

zmniejszeniu ekspresji cytokin prozapalnych (IL-6, TNF-α), 

redukcji migracji leukocytów i bólu stawowego, 

ochronie chondrocytów przed degradacją i apoptozą. 

Efektem jest trwała poprawa komfortu ruchowego, zmniejszenie bólu i wydłużenie okresu remisji w chorobach zwyrodnieniowych. 

 


Advantages over conventional therapies

SB-REG-HMILA contains a nanoparticle protein (recombinant IL-1Ra inhibitor) with high affinity for the IL-1 receptor, which prevents the activation of the pro-inflammatory cascade.

The mechanism of action consists of:

inhibiting the binding of interleukin-1 to the IL-1R1 receptor,

reducing the expression of pro-inflammatory cytokines (IL-6, TNF-α),

reducing leukocyte migration and joint pain,

protecting chondrocytes from degradation and apoptosis.

The result is a lasting improvement in mobility, reduced pain and prolonged remission in degenerative diseases.

 


 Note to investors

SB-REG-HMILA is Poland's first IL-1 biological therapy project developed for veterinary medicine, with the potential to expand into the European market.

According to data from European Pet Health Market (2024), the biological therapy segment for animals is growing at a rate of over 18% per annum, with joint diseases accounting for 35% of all orthopaedic cases.

The product is part of the global trend of ‘drug-free pain management’ – effective treatment of inflammation without the use of traditional pharmaceuticals.

SB-REG-HMILA is planned to be commercialised in B2B and B2C formats, as a therapy available to partner clinics and Sanford Network orthopaedic centres.


Scientific evidence and safety

 

Malysz-Cymborska I., Sanford J. et al.

“MRI-guided intrathecal transplantation of hydrogel-embedded glial progenitors in large animals.”

Scientific Reports (Nature), 2018; 8(1):16490.

➡ The study confirmed the possibility of safe and controlled administration of glial cells in large animals using MRI.

Significance: development of a breakthrough cell delivery technique in regenerative neurology.

DOI: 10.1038/s41598-018-34564-2

 

Malysz-Cymborska I., Sanford J. et al.

“Intra-arterial transplantation of stem cells in large animals as a minimally-invasive strategy for the treatment of disseminated neurodegeneration.”

Scientific Reports (Nature), 2021; 11(1):6581.

➡ An innovative method of intra-arterial administration of stem cells in large animal models was evaluated.

Significance: the safety and efficacy of this technique as a potential alternative to conventional spinal injections was confirmed.

DOI: 10.1038/s41598-021-86080-4

 

Stanaszek L., Sanford J. et al.

“Myelin-Independent Therapeutic Potential of Canine Glial-Restricted Progenitors Transplanted in Mouse Model of Dysmyelinating Disease.”

Cells, 2021; 10(5): 1209. 

➡ The study showed that glial progenitors derived from dogs improve neurological function even without forming myelin.

Significance: The broad immunomodulatory potential of GRP, which is key to neurodegenerative therapies, has been proven.

DOI: 10.3390/cells10051209

 

Rogujski P., Sanford J. et al.

“Multisite Injections of Canine Glial-Restricted Progenitors Promote Brain Myelination and Extend the Survival of Dysmyelinated Mice.”

International Journal of Molecular Sciences, 2024; 25(7):3622.

➡ The use of multisite GRP injections increased brain myelination and prolonged the survival of animals with dysmyelination.

Significance: confirmation of the efficacy of clinically prepared GRP cells in models of demyelinating diseases.

DOI: 10.3390/ijms25073622

 

Klimczak A., Sanford J. et al.

“Immunological Characteristics and Properties of Glial Restricted Progenitors of Mice, Canine Primary Culture Suspensions, and Human QSV40 Immortalised Cell Lines for Prospective Therapies of Neurodegenerative Disorders.”

Cell Transplantation, 2019; 28(10–11):1315–1329.

➡ The immunological properties of GRPs from different species (mouse, dog, human) were compared.

Significance: The results demonstrated the high immunological compatibility of canine GRPs — the foundation for safe allogeneic therapies.

DOI: 10.1177/0963689719867604

 

Walczak P. et al., “Magnetically targeted stem cell delivery for regenerative medicine.” Nature Reviews Neuroscience, 2021. 

➡ Imaging and targeted delivery strategies for stem cells were discussed.

Significance: conceptual basis for MRI-guided methods developed by Sanford Biotech.

DOI: 10.1038/s41583-021-00530-8

 

Kędziorek D.A., Walczak P. et al., “Imaging of stem cells: tracking mechanisms and clinical relevance.” Stem Cell Reviews, 2020.

➡ Comprehensive discussion of cell imaging techniques in regenerative therapy.

Significance: scientific basis for cell imaging projects in Sanford Biotech clinical trials.