Can Thykamine change the future of MASH treatment? Devonian Health Group says yes!

Devonian Health Group Inc. (TSXV: GSD; OTCQB: DVHGF), a clinical-stage pharmaceutical company, has announced promising preclinical results for its proprietary drug candidate, Thykamine, in MASH liver disease. The study, conducted in a widely recognized MASH liver disease animal model, demonstrated that Thykamine effectively reduced liver inflammation and fibrosis, two key hallmarks of the disease.

The findings indicate that Thykamine could emerge as a novel therapeutic option alongside Resmetirom, the first FDA-approved drug for managing MASH liver disease. With no widely available treatments addressing the underlying inflammatory and fibrotic mechanisms of MASH, these results suggest that Thykamine may hold potential as an alternative or complementary therapy.

How Did Thykamine Perform in the MASH Study?

The study, conducted by SMC Laboratories in Japan, evaluated the impact of Thykamine anti-inflammatory effects on disease progression in a well-established MASH liver disease mouse model. The research simulated metabolic dysfunction-associated steatohepatitis (MASH) in diabetic mice by feeding them a high-fat diet, triggering liver fat accumulation, inflammation, and fibrosis.

Resmetirom, which was recently approved by the U.S. Food and Drug Administration (FDA) as the first treatment for MASH liver disease, was used as a control at an oral dose of 3.0 mg/kg daily for three weeks. Thykamine was tested at varying doses—0.5 mg/kg, 5.0 mg/kg, and 50.0 mg/kg—administered orally once per day over the same period.

The study found that Thykamine anti-inflammatory effects led to a significant reduction in liver NAFLD activity score (NAS), a key indicator of disease severity that assesses steatosis, inflammation, and hepatocyte ballooning. The compound also lowered α-SMA expression, a widely used marker of liver fibrosis. Further analysis showed that Thykamine decreased the presence of collagen type I and type III, which contribute to fibrosis progression, as well as F4/F80 expression, Ly-6G expression, and MARCO (macrophage receptor with collagen structure) expression—all key factors in liver damage.

Importantly, the study demonstrated that the effects of Thykamine were comparable to those of Resmetirom, suggesting that it could play a crucial role in future MASH treatment strategies.

Why Is MASH Liver Disease a Growing Concern?

MASH liver disease, formerly known as nonalcoholic steatohepatitis (NASH), is a severe progression of nonalcoholic fatty liver disease (NAFLD), which affects an estimated 20-30% of the global population. NAFLD is closely linked to metabolic disorders such as obesity, type 2 diabetes, dyslipidemia, and hypertension.

As MASH liver disease advances, it leads to chronic inflammation, hepatocellular ballooning, and fibrosis, which can result in cirrhosis, liver cancer, organ failure, and death. Despite its rising prevalence, MASH liver disease has remained a significant unmet medical need due to the lack of widely available therapeutic options.

The approval of Resmetirom marked a significant milestone in MASH treatment, but additional anti-inflammatory and anti-fibrotic therapies are urgently needed to address the disease’s complex pathology. Thykamine anti-inflammatory effects position it as a potential game-changer in this space.

What Makes Thykamine Unique in Liver Disease Treatment?

Thykamine is a pharmaceutical compound developed under Devonian’s SUPREX platform, a proprietary approach focused on treating autoimmune and inflammatory diseases. Initially investigated for conditions such as ulcerative colitis, atopic dermatitis, psoriasis, and rheumatoid arthritis, the drug has demonstrated strong anti-inflammatory and immunomodulatory properties in multiple preclinical and clinical studies.

Thykamine has undergone Phase II clinical trials for atopic dermatitis and ulcerative colitis, where it exhibited a favorable safety profile and significant efficacy in reducing inflammation and oxidative stress. The latest findings in MASH liver disease expand its potential therapeutic applications to hepatic conditions, opening new avenues for its development.

Dr. Andre P. Boulet, Chief Scientific Officer at Devonian Health Group, emphasized the significance of the study’s findings, stating:

“These results provide compelling proof of concept for Thykamine in MASH. Its anti-inflammatory effects have been well documented, and now we see its ability to reduce fibrosis progression, which could make it a key player in the fight against MASH liver disease.”

Luc Gregoire, President and CEO of Devonian Health Group, highlighted the broader implications of the study:

“Thykamine’s multi-targeting mechanism allows it to affect key inflammatory and fibrotic pathways. This could make it a valuable candidate for hepatic conditions in addition to its current focus areas like dermatology and inflammatory bowel disease (IBD).”

What Are the Next Steps for Thykamine in MASH Research?

Following these promising preclinical results, Devonian Health Group plans to submit the full MASH preclinical findings for publication later in 2025. Additionally, a gene expression analysis is currently underway to further explore Thykamine anti-inflammatory effects at the molecular level.

While Thykamine has not yet entered clinical trials for MASH liver disease, these preclinical findings provide a strong foundation for future development. Given the FDA’s regulatory framework for prescription botanical drug products, Devonian may benefit from an accelerated approval pathway if Thykamine anti-inflammatory effects continue to demonstrate significant potential in future studies.

With MASH liver disease emerging as a global health crisis, Devonian Health Group is positioning Thykamine as a potential therapeutic breakthrough. If clinical trials validate these findings, Thykamine could offer a novel approach to treating MASH, reducing reliance on single-agent therapies and addressing the disease from multiple inflammatory and fibrotic pathways.