With an estimated 1 in 100 dogs and cats developing diabetes in their lifetime, nearly 1.5 million pets will at some point need therapies to manage diabetes. Today, the only treatment option is daily insulin injections, putting enormous stress on pet parents, their pets, and veterinarians. Unfortunately, in a large number of cases, pet owners don’t pursue treatment, choosing euthanasia instead. Euthanasia is also often elected when treatment becomes difficult or fails.
Giving Veterinarians a Cell-Based Alternative Treatment Option for Diabetic Pets
Where We Stand in the Process of Treating Diabetic Pets
Likarda is a biotech company focused on next generation cell-based therapies for pets. Our scientists are developing a potentially better way to manage diabetes in dogs and cats. Our insulin-producing cell clusters can be transplanted into animals with diabetes. We are testing a transplant for dogs and are developing a cat version. Our goal is to provide veterinarians with a minimally-invasive, cost-effective solution for pet owners who are battling the burden of managing diabetes in their pets.
Replacing Traditional Diabetes Treatment with Cell-Based Therapies
Spanning more than 30 years of research, insulin-producing cell transplantation has been researched as a therapeutic option to replace multiple, daily insulin injections. Insulin-producing cells have been transplanted in people with diabetes since 2000, returning blood glucose levels to normal within days and maintaining these levels with 40-80 percent success for years
As this therapy was being developed for humans, much of the pre-clinical testing was conducted in laboratory dogs, as canine diabetes is quite similar to human type 1 diabetics. In fact, over 250 peer-reviewed research publications from around the world, with thousands of dogs as the recipients of insulin-producing cell transplants, have provided data to support progress on human transplants to treat diabetes. Many of the initial studies showcased the use of islets but required organ donations from multiple human donors to treat a single person with diabetes. However, in the last decade, there has been a push to utilize insulin-producing cells from renewable cell sources such as stem cells.
Likarda asked the question: With so many dogs receiving insulin-producing cell transplants as part of research studies, why hasn’t this become an option for diabetic dogs?
Insulin-producing cell transplantation offers a potential solution for pets with diabetes. Likarda is focused on replacing daily insulin injections with an insulin-producing cell transplant for dogs. In striving to reach this goal we have, over the past five years, made great progress based on our own in-house research and from the efforts of the many partners who work with us
How Does It Work?
Insulin-producing cells are grown in the lab and then encapsulated with a hydrogel that extends the life of the transplant. These cell-containing microbeads are transplanted via an injection into the omentum (peritoneum) of the diabetic dog. There these cells sense the animal’s glucose levels and release insulin accordingly.
How Long Does the Transplant Last?
The hydrogel is key to answering this question. We are using advanced hydrogels that are crosslinked to create very stable and long-lasting encapsulants that hold the transplanted cells in place, while allowing nutrients to diffuse freely between them and the surrounding tissues. Although we have ample safety data showing that the hydrogel materials are safe for use, to answer the duration question we will need to conduct clinical studies that use periodic veterinary examinations to follow diabetic dogs that received the transplanted microencapsulated cells.
Is This Treatment Regulated by the FDA?
We are working together with the Center for Veterinary Medicine (CVM), a division of the FDA, to navigate the appropriate regulatory pathway for this type of cell-based therapy for pets. Likarda is working to bring the first FDA-CVM approved and cost-effective cell therapy for diabetic pets to market.
When Will It Be Available to Veterinarians?
While we hope to be able to launch a product in the next few years, this will depend largely on the continued success of our R&D program in meeting project milestones and on the path we must follow to gain regulatory approval. To see our plans and progress, click here: current pipeline.
You Mentioned Dogs…What About A Treatment For Cats?
For diabetic cats, the development process is more challenging. Minimal prior research in cat exists, so we are developing the treatment from the beginning. We are early in the process, investigating a variety of sources of cells to create insulin-producing cell therapy for cats.
Trial Candidates for the Clinical Testing Phase
We are working with the FDA’s Center for Veterinary Medicine to conduct clinical trials on the transplant for dogs, called DOGLET™. If you have a client whose pet could be considered for future clinical trials, or if you’d like to receive updates on the therapy, please fill out our information request form.