SB-REG-FKIDNEY
– stem cell therapy(MSC) in nephropathy and proteinuria in cats
 

Introduction

Nephropathy and the accompanying proteinuria are among the most common chronic kidney diseases in cats, especially those over 8 years of age. They lead to progressive damage to the renal parenchyma, accumulation of metabolic toxins and water and electrolyte imbalances. Standard treatment (diet, blood pressure-lowering drugs, diuretics) is symptomatic and does not stop the degenerative processes in the renal tissue. SB-REG-KIDNEY is a drug candidate based on mesenchymal stem cells (MSCs) designed to reduce inflammation and fibrosis, regenerate the kidneys after poisoning, and rebuild their structures.

A modern approach – MSC therapy

The SB-REG-FKIDNEY preparation contains live, allogeneic mesenchymal stem cells derived from the adipose tissue of healthy donors of the same species. These cells exhibit strong anti-inflammatory, anti-fibrotic and regenerative properties. After intravenous administration, they migrate to the kidneys, where they:

  • reduce inflammation and oxidative stress in the glomeruli,
  • stimulate the regeneration of tubular cells,
  • improve microcirculation and renal flow,</li> <li>limit the progression of parenchymal fibrosis.

The effect of the therapy is an improvement in renal filtration function, a reduction in proteinuria and a slowdown in the development of chronic renal failure.

How it works

The MSCs contained in the preparation secrete trophic factors such as VEGF, HGF, TGF-β and IGF-1, which support tissue repair and modulate the activity of the immune system. Thanks to their immunomodulatory properties, MSCs reduce excessive inflammatory responses without triggering a host immune reaction, which is why allogeneic therapy is safe and well tolerated.

 

Clinical benefits

 

  • reduction in blood creatinine and urea levels,
  • reduction in proteinuria (protein loss in urine),
  • improved hydration and appetite,
  • increased energy levels and quality of life for your cat.

 

Safety and form of administration

Preparat SB-REG-FKIDNEY jest wytwarzany w warunkach <abbr title="Good Manufacturing Practice – Dobra Praktyka Wytwarzania">GMP</abbr> jako jałowa zawiesina komórek w medium fizjologicznym. Produkt jest dostarczany w formie głęboko mrożonej, gotowej do użycia bezpośrednio po rozmrożeniu („off-the-shelf”). Podanie odbywa się w formie kroplówki dożylnej w warunkach kliniki weterynaryjnej.  

 

Stages of therapy

1. Patient qualification: blood and urine tests, assessment of kidney function (SDMA, creatinine, BUN, protein-to-creatinine ratio).

2. MSC administration: single intravenous infusion or a cycle of two administrations 4–6 weeks apart.

3. Monitoring of effects: repeat biochemical tests after 1 and 3 months.

 

Summary

SB-REG-FKIDNEY therapy represents a new generation of biological methods for supporting kidney function in cats with chronic kidney disease. Thanks to the regenerative and anti-inflammatory effects of MSC cells, it is possible to slow down the degeneration process, improve biochemical parameters and prolong the life of nephrology patients.

Note to investors

SB-REG-FKIDNEY is an advanced therapeutic project developed by Sanford Biotech, focused on the treatment of chronic renal failure and degenerative nephropathy in cats using mesenchymal stem cells (MSCs). The product is part of the SB-REG portfolio, which includes Advanced Veterinary Medicinal Products (ATMP-VET) biological medicines.

 

Preliminary results from preclinical studies confirm that MSCs isolated from adipose tissue have strong immunomodulatory, anti-inflammatory and anti-fibrotic effects, and also support nephron regeneration and renal microcirculation. The therapy reduces the effects of chronic inflammatory processes, regenerates structures and improves renal filtration functions.

 

The SB-REG-FKIDNEY product is designed as an allogeneic cell preparation in the form of a sterile MSC suspension. Thanks to the developed technology, the preparation will be available in an ‘off-the-shelf’ formula, ready for use after thawing, which significantly increases its commercial potential and market scalability.

 

From a veterinary market perspective, kidney disease is one of the leading causes of mortality in cats, accounting for over 20% of cases of multi-organ failure. Currently used therapies are symptomatic and do not lead to kidney tissue regeneration, which opens up space for cell therapies as a causal solution.

 

Sanford Biotech plans to obtain comprehensive safety, bioavailability and clinical efficacy data through R&D studies conducted in accordance with VICH GL9 and GL60 guidelines in dog and cat models. Ultimately, the project is to be submitted for registration as a veterinary biological medicinal product in the ATMP-VET category.

 

Key investment advantages:

  • Growing market for biological therapies in veterinary medicine (CAGR > 12% until 2030),
  • High projected profitability in the segment of renal therapies for older animals,
  • Off-the-shelf technology enabling commercialisation in a B2B model (veterinary clinics/distributors),
  • Transferability of results to the human translational medicine segment,
  • Project protected by patents for MSC formulations and application methods.