Devonian Reports Positive Results in MASH Liver Study
Devonian Health Group (TSXV: GSD; OTCQB: DVHGF) announced positive preclinical results for Thykamine™ in MASH (metabolic dysfunction-associated steatohepatitis) liver treatment. The study, conducted at SMC Laboratories in Japan, used the STAM mouse model to evaluate Thykamine's effects on liver disease progression.
The results showed that Thykamine™, administered orally at doses of 0.5, 5.0, and 50.0 mg/kg daily for 3 weeks, demonstrated significant hepatoprotective effects. The treatment lowered the NAFLD activity score (NAS) and decreased various markers including α-SMA, collagen types I and III, F4/F80, Ly-6G, and MARCO expression. These effects were comparable to Resmetirom, the first FDA-approved MASH management drug.
The complete MASH preclinical results are planned for publication in 2025.
Devonian Health Group (TSXV: GSD; OTCQB: DVHGF) ha annunciato risultati preclinici positivi per Thykamine™ nel trattamento della MASH (steatoepatite associata a disfunzione metabolica). Lo studio, condotto presso i laboratori SMC in Giappone, ha utilizzato il modello murino STAM per valutare gli effetti di Thykamine sulla progressione della malattia epatica.
I risultati hanno mostrato che Thykamine™, somministrato per via orale a dosi di 0,5, 5,0 e 50,0 mg/kg al giorno per 3 settimane, ha dimostrato effetti epatoprotettivi significativi. Il trattamento ha ridotto il punteggio di attività NAFLD (NAS) e ha diminuito vari marcatori tra cui α-SMA, i tipi di collagene I e III, F4/F80, Ly-6G e l'espressione di MARCO. Questi effetti sono stati comparabili a quelli di Resmetirom, il primo farmaco approvato dalla FDA per la gestione della MASH.
I risultati completi preclinici sulla MASH sono previsti per la pubblicazione nel 2025.
Devonian Health Group (TSXV: GSD; OTCQB: DVHGF) anunció resultados preclínicos positivos para Thykamine™ en el tratamiento de la MASH (esteatohepatitis asociada a disfunción metabólica). El estudio, realizado en los laboratorios SMC en Japón, utilizó el modelo de ratón STAM para evaluar los efectos de Thykamine en la progresión de la enfermedad hepática.
Los resultados mostraron que Thykamine™, administrado por vía oral a dosis de 0.5, 5.0 y 50.0 mg/kg diariamente durante 3 semanas, demostró efectos hepatoprotectores significativos. El tratamiento redujo el puntaje de actividad NAFLD (NAS) y disminuyó varios marcadores, incluyendo α-SMA, tipos de colágeno I y III, F4/F80, Ly-6G y la expresión de MARCO. Estos efectos fueron comparables a los de Resmetirom, el primer medicamento aprobado por la FDA para el manejo de la MASH.
Los resultados preclínicos completos sobre la MASH están previstos para su publicación en 2025.
Devonian Health Group (TSXV: GSD; OTCQB: DVHGF)는 MASH(대사 기능 장애와 관련된 지방간염) 간 치료를 위한 Thykamine™의 긍정적인 전임상 결과를 발표했습니다. 일본 SMC 연구소에서 수행된 이 연구는 STAM 마우스 모델을 사용하여 Thykamine의 간 질환 진행에 대한 영향을 평가했습니다.
결과는 Thykamine™이 3주 동안 매일 0.5, 5.0 및 50.0 mg/kg의 용량으로 경구 투여되었을 때, 상당한 간 보호 효과를 나타냈습니다. 이 치료는 NAFLD 활동 점수(NAS)를 낮추고 α-SMA, 콜라겐 유형 I 및 III, F4/F80, Ly-6G 및 MARCO 발현을 포함한 다양한 표지자를 감소시켰습니다. 이러한 효과는 MASH 관리 약물로 FDA 승인을 받은 첫 번째 약물인 Resmetirom과 유사했습니다.
MASH에 대한 전임상 결과의 전체 내용은 2025년 발표될 예정입니다.
Devonian Health Group (TSXV: GSD; OTCQB: DVHGF) a annoncé des résultats précliniques positifs pour Thykamine™ dans le traitement de la MASH (stéatohépatite associée à une dysfonction métabolique). L'étude, réalisée dans les laboratoires SMC au Japon, a utilisé le modèle murin STAM pour évaluer les effets de Thykamine sur la progression de la maladie hépatique.
Les résultats ont montré que Thykamine™, administré par voie orale à des doses de 0,5, 5,0 et 50,0 mg/kg quotidiennement pendant 3 semaines, a démontré des effets hépatoprotecteurs significatifs. Le traitement a réduit le score d'activité NAFLD (NAS) et a diminué divers marqueurs, y compris α-SMA, les types de collagène I et III, F4/F80, Ly-6G et l'expression de MARCO. Ces effets étaient comparables à ceux de Resmetirom, le premier médicament approuvé par la FDA pour la gestion de la MASH.
Les résultats précliniques complets sur la MASH sont prévus pour publication en 2025.
Devonian Health Group (TSXV: GSD; OTCQB: DVHGF) hat positive präklinische Ergebnisse für Thykamine™ bei der Behandlung von MASH (metabolisch bedingte Steatohepatitis) bekannt gegeben. Die Studie, die in den SMC-Laboren in Japan durchgeführt wurde, verwendete das STAM-Mausmodell, um die Auswirkungen von Thykamine auf den Fortschritt der Lebererkrankung zu bewerten.
Die Ergebnisse zeigten, dass Thykamine™, das oral in Dosen von 0,5, 5,0 und 50,0 mg/kg täglich über einen Zeitraum von 3 Wochen verabreicht wurde, signifikante hepatoprotektive Effekte aufwies. Die Behandlung senkte den NAFLD-Aktivitätswert (NAS) und verringerte verschiedene Marker, darunter α-SMA, Kollagen Typ I und III, F4/F80, Ly-6G und die MARCO-Expression. Diese Effekte waren vergleichbar mit Resmetirom, dem ersten von der FDA zugelassenen Medikament zur Behandlung von MASH.
Die vollständigen präklinischen Ergebnisse zu MASH sind für die Veröffentlichung im Jahr 2025 geplant.
- Thykamine™ showed comparable effectiveness to FDA-approved Resmetirom in MASH treatment
- All tested doses (0.5, 5.0, 50.0 mg/kg) demonstrated significant hepatoprotective effects
- Treatment significantly lowered NAFLD activity score (NAS) compared to control group
- Results indicate potential expansion into liver disease treatment market
- Complete study results won't be published until 2025
- Still in preclinical stage, requiring further clinical trials before commercialization
- Positive results from the STAM mouse model in vivo study attributing Thykamine™ with anti-MASH and anti-fibrosis effects in liver
- Compelling results compared to Resmetirom, the first FDA approved drug for management of MASH
The study investigated the effects of Thykamine™ on liver disease progression in the widely used STAM mouse model of MASH/fibrosis at SMC Laboratories in
Thykamine™ administered orally, at doses of 0.5 mg/kg, 5.0 mg/kg and 50.0 mg/kg, once a day for 3 weeks provided a hepatoprotective effect preventing liver disease progression compared to the control group (vehicle). Specifically, Thykamine™ treatment resulted in a significant lowering of the liver NAFLD activity score (NAS), a composite measure of fatty liver disease composed of steatosis, inflammation and hepatocyte ballooning. The α-SMA, a marker used to evaluate liver fibrosis, was also significantly decreased. Thykamine™ treatment decreased liver type collagen type I expression, collagen type III score, F4/F80 expression, Ly-6G expression and MARCO (macrophage receptor with collagen structure) expression. The effects on these markers were comparable to the effects of Resmeritom. Overall, progression of liver fibrosis was reduced by Thykamine™ treatment. Gene expression analysis data should be released shortly. The complete MASH preclinical results are planned to be submitted for publication in 2025.
Group |
NAS (Mean ± SD |
|
Normal |
0.0 ± 0.0 |
|
Vehicule |
4.9 ± 0.6 |
|
Thykamine 0.5 mg/kg |
3.1 ± 1.0 |
p < 0.05 |
Thykamine 5.0 mg/kg |
2.9 ± 1.1 |
p < 0.05 |
Thykamine 50.0 mg/kg |
2.8 ± 0.9 |
p < 0.05 |
Resmetirom 3.0 mg/kg |
2.6 ± 0.7 |
p < 0.05 |
“We are delighted with the outcome of this preclinical study and look forward to sharing more detail in a planned upcoming scientific publication. The data demonstrate an exciting proof of concept data of Thykamine™ anti-inflammatory and anti-fibrotic effects in MASH. Historical preclinical and clinical studies of Thykamine™ have demonstrated its anti-inflammatory properties. The anti-fibrotic MASH data adds an important key complementary feature of Thykamine™ mechanism of action. In inflammatory diseases, fibrosis typically develops in response to repeated injuries or chronic inflammation. The MASH study demonstrates that Thykamine™ has anti-inflammatory and anti-fibrotic effects with the potential to target underlying disease pathology and therefore stop the progression of the disease”, said Dr. Andre P. Boulet, PhD, Chief Scientific Officer of the Company.
“This is one more study in the arsenal of Thykamine™, demonstrating its multi targeting mode of action affecting the cytokines affecting inflammation, opening up a broad array of possible applications for our lead product in underserved auto immune inflammatory diseases, which now adds hepatic conditions to our other targets such as dermatology and IBD”, said Luc Gregoire, president and CEO of the Company.
About NAFLD/MASH1,2
Nonalcoholic fatty liver disease (NAFLD) is the most common form of chronic liver disease with a worldwide prevalence of 20
NAFLD progresses to metabolic dysfunction-associated steatohepatitis (MASH), the hallmarks of which are inflammation, hepatocellular ballooning, and subsequent worsening fibrosis. Left untreated, MASH can ultimately progress to cirrhosis of the liver and hepatocellular carcinoma, liver failure and death.
About Thykamine™
Thykamine™, the first pharmaceutical product issued from Devonian’s SUPREX™ platform, is a highly innovative product for the prevention and treatment of health conditions related to inflammation and oxidative stress including ulcerative colitis, atopic dermatitis, psoriasis, rheumatoid arthritis, and other autoimmune disorders. The anti-inflammatory, anti-oxidative and immunomodulatory properties of Thykamine™ have been demonstrated by a considerable number of in vitro and in vivo studies as well as in a Phase IIa clinical study in patients with mild-to-moderate distal ulcerative colitis and in a large phase II study in adult patients with mild-to-moderate Atopic Dermatitis. Both Thykamine™ and SUPREX™ platform are protected by several patents in
About Devonian
Devonian Health Group Inc. is a clinical stage pharmaceutical company specializing in the development of drugs for various auto-immune inflammatory conditions with novel therapeutic approaches to targeting unmet medical needs. Devonian’s core strategy is to develop prescription drugs for the treatment of inflammatory autoimmune diseases including but not limited to ulcerative colitis and atopic dermatitis. Based on a foundation of over 15 years of research, Devonian’s focus is further supported by a
Devonian is also involved in the development of high-value cosmeceutical products leveraging the same proprietary approach employed with their pharmaceutical offerings. Devonian also owns a commercialization subsidiary, Altius Healthcare Inc., focused on selling prescription pharmaceutical products in
Devonian Health Group Inc. was incorporated in 2015 and is headquartered in
For more information, visit www.groupedevonian.com
References
- Ekstedt M, Nasr P and Kechagias S. Natural History of NAFLD/NASH. Curr Hepatology Rep. 16:391-397, 2017.
- Pierantonelli I. and Svegliati-Baroni G. Nonalcoholic Fatty Liver Disease: basic Pathogerenic Mechanisms in the Progression from NAFLD to NASH. Transplantation, 103(1): p e1-e13, 2019
Cautionary Note Regarding Forward-Looking Statements
All statements, other than statements of historical fact, contained in this press release including but, not limited to those relating to the economical impact of clinical study, the efficiency of the high anti-inflammatory potency proven and the position of the Thykamine™ as a possible first line treatment of choice for several autoimmune conditions in the early stages of the disease and the reduced need for aggressive treatments with biologics and other immune modulators, that are associated with serious side effects and long term negative consequences, and, generally, the above “About Devonian” and “About Altius” paragraphs, which essentially describes the Corporation’s outlook, constitute “forward-looking information” or “forward-looking statements” within the meaning of certain securities laws, and are based on expectations, estimates and projections as of the time of this press release.
Forward-looking statements are necessarily based upon a number of estimates and assumptions that, while considered reasonable by the Corporation as of the time of such statements, are inherently subject to significant business, economic and competitive uncertainties and contingencies. These estimates and assumptions may prove to be incorrect. Many of these uncertainties and contingencies can directly or indirectly affect, and could cause, actual results to differ materially from those expressed or implied in any forward-looking statements. There can be no assurance that these assumptions will prove to be correct and there can be no assurance that forward-looking statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements.
By their very nature, forward-looking statements involve inherent risks and uncertainties, both general and specific, and risks exist that estimates, forecasts, projections and other forward-looking statements will not be achieved or that assumptions do not reflect future experience. Forward-looking statements are provided for the purpose of providing information about management’s expectations and plans relating to the future. Readers are cautioned not to place undue reliance on these forward-looking statements as a number of important risk factors and future events could cause the actual outcomes to differ materially from the beliefs, plans, objectives, expectations, anticipations, estimates, assumptions and intentions expressed in such forward-looking statements. All of the forward-looking statements made in this press release are qualified by these cautionary statements and those made in our other filings with the applicable securities regulators of
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Devonian Health Group Inc.
Mr. Luc Gregoire
President & CEO
Dr. Andre P. Boulet, PhD
Chief Scientific Officer
Telephone: 1 (450) 979-2916
E-mail: investors@groupedevonian.com
Renmark Financial Communications Inc.
Mr. Ben Ozerkevich
Telephone: (416) 644-2020 or (212) 812-7680
E-mail: bozerkevich@renmarkfinancial.com
www.renmarkfinancial.com
Source: Devonian Health Group Inc.
FAQ
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