Ethos Discovery and Gallant Therapeutics Collaborate on Study Evaluating Gallant’s Stem Cell Therapy in Pugs with Necrotizing Meningoencephalitis (NME), also referred to as Pug Dog Encephalitis (PDE)

NME is a progressive, typically fatal autoimmune disease characterized by brain inflammation, that has no disease-modifying treatment options available

SAN DIEGO and WOBURN, Mass., Oct. 03, 2023 (GLOBE NEWSWIRE) — The Simons are a Pug family. When their family pug, Walter, was two years old, the Simons noticed that for a few months, Walter wasn’t himself; he was less interactive and often confused. One day, he had a sudden onset of severe seizures. Within 24 hours, Walter was diagnosed with pug dog encephalitis (PDE), a common name for necrotizing meningoencephalitis (NME) because it occurs most commonly in that breed. Despite aggressive therapy with steroids, immunosuppressants, and anti-seizure medications, Walter died within 24 hours of his diagnosis.

NME is a devastating and often fatal autoimmune disease of the brain. Although most pugs exhibit symptoms including lethargy, behavioral changes, seizures, circling, and visual deficits, between the ages of 1.5 and 2.5 years old, they are usually asymptomatic until advanced inflammation has already developed within the brain, limiting effective treatment options. Pugs may appear normal then be severely affected within days. Even with aggressive treatment with steroids and auto-immune medicines, most pugs with NME won’t live longer than 6 months from the time of diagnosis.

The Simons’ experience with Walter is a devastatingly common reality for families whose pugs have NME, as common signs of early NME often go undetected until the disease has progressed. Ethos Discovery, a nonprofit organization developing innovative medical treatments and tests that benefit pets and humans, and Gallant Therapeutics, an animal health biotechnology company pioneering off-the-shelf stem cell therapies for pets, today announced their collaboration on the third study of an ongoing clinical trials program designed to investigate Gallant’s stem cell therapy as an effective and safe product to help pugs with NME.

A Media Snippet accompanying this announcement is available by clicking on the image or link below:

Ethos Discovery previously identified an early form of NME characterized by a combination of symptoms including neck and back pain, reduced visual processing on one side, and reduced paw placement (usually on the same side as the reduced visual processing).

In this current phase of the clinical program, Gallant Mesenchymal Stem Cells (MSCs) will be used to treat pugs with early-stage NME with the goal of preventing further brain damage, improving clinical signs and minimizing disease progression. MSCs are well known to have immunomodulatory and anti-inflammatory properties,^1,2 targeting the root cause of disease, and thereby potentially altering the abnormalities that lead to the severe brain inflammation associated with NME.

Based on their experience with Walter, the Simons had their other two pugs screened for signs of early NME, and one of these Pugs, Mary Katherine, was determined to be genetically high risk. She also had some of the symptoms of early NME including a dull demeanor, spinal pain, reduced paw placement, reduced vision, and loss of balance. Mary Katherine was treated with stem cells, and after 24 hours, her spinal pain and neurological deficits improved, and the Simons owners noticed an increase in her energy level and playfulness.

“Ethos Discovery and Gallant Therapeutics are natural partners in this type of clinical research, as we both believe that evidence is paramount to advancing innovation,” said Chand Khanna, DVM, PhD, DACVIM (Onc), DACVP (Hon), Ethos Discovery Board Chair. “We are very glad to have Gallant Therapeutics as a partner because of this shared priority, as well as Gallant’s scientific rigor in developing stem cell therapies.”

“Like millions of dogs and cats with inflammatory or immune-mediated diseases, current treatment options for NME only address the symptoms, and most pugs with advanced disease die despite these therapies. If we can change their underlying immune dysfunction with stem cells, we have a chance of saving more pugs,” said Linda Black, DVM, PhD, CEO of Gallant Therapeutics. “We are thrilled to collaborate with Ethos Discovery to evaluate the use of MSCs to help prevent the most devastating outcomes of NME.”

Ethos Discovery is conducting these trials in collaboration with human research groups who seek to use the data to support similar clinical trials in humans with diseases that behave similarly to NME, such as multiple sclerosis.

More about the Ethos Discovery Clinical Program of NME in Pugs
The overarching goals of this clinical program are to identify symptoms in pugs that are high risk for NME that could be used to diagnose the disease earlier, and to identify new treatment options that will provide improved clinical signs and long-term survival times. In two earlier ‘pug clinics’ hosted by Ethos Discovery, clinicians conducted neurological, blood, and genetic testing for NME, and identified a possible early clinical phenotype (i.e., combination of symptoms) of NME that may allow for the disease to be diagnosed and treated at an earlier stage. In this third study in the program, Ethos Discovery and Gallant Therapeutics are investigating treatment with Gallant’s MSCs in pugs previously screened for NME. To learn more about enrolling your pug in the study, please visit: https://www.ethosdiscovery.org/clinical-study/necrotizing-meningoencephalitis-study-for-pugs-seep-steep/.

About Ethos Discovery
Ethos Discovery is a 501(c)3 nonprofit organization devoted to developing innovative medical treatments and tests that benefit both pets and humans. Through targeted research, clinical trials, and the delivery of advanced veterinary care, we seek to address unmet clinical needs to improve health outcomes for humans and animals with complex medical problems.

Ethos Discovery is uniquely positioned, with the support of Ethos Veterinary Health, to reach patients and doctors nationally and to partner with key international leaders in their field. This flexibility provides us the opportunity to pursue impactful research that will make a difference where it is most important, within clinical hospitals and for patients and families. Our scientific portfolio is currently focused on: Oncology, Neurology, Emergency and Critical Care, Innovations in Surgery, Internal Medicine, Anesthesia and Drug Repurposing. For more information, visit EthosDiscovery.org.

About Gallant Therapeutics
Gallant Therapeutics is a clinical-stage animal health biotechnology company setting a new standard in animal health by harnessing the power of stem cell therapy to treat the root cause of diseases in dogs and cats. Gallant’s pipeline of off-the-shelf mesenchymal stem cell (MSC) therapies has the potential to treat a broad range of diseases, including canine and feline osteoarthritis (OA), feline chronic kidney disease (CKD) and others. The first product based on our uterine-derived platform, for feline chronic gingivostomatitis (FCGS), is on track for conditional approval by the FDA in 2025. United by a love of and commitment to animals, Gallant’s team includes industry leaders in veterinary regenerative medicine with deep experience in cell therapy product development, manufacturing and commercialization. To learn more about the potential of our stem cell therapies, visit GallantTherapeutics.com.

Media contacts:
Gallant Therapeutics
Adam Silverstein
Adam@ScientPR.com

Ethos Discovery
Tina Rice
Executive Director
trice@ethosvet.com

Clinical trial contact:
Rebecca Windsor, DVM, DACVIM
Veterinary Neurologist
WRAHNeurology@wrah.com
720-213-2720

¹ Carrade DD, Borjesson DL. Immunomodulation by mesenchymal stem cells in veterinary species. Comp Med. 2013 Jun;63(3):207-17. PMID: 23759523; PMCID: PMC3690426.
² Wu, X., Jiang, J., Gu, Z. et al. Mesenchymal stromal cell therapies: immunomodulatory properties and clinical progress. Stem Cell Res Ther 11, 345 (2020). https://doi.org/10.1186/s13287-020-01855-9.