Galmed Unveils Novel Pharmacodynamic Blood Markers for Aramchol, the Most Clinically Advanced SCD1 Inhibitor
Galmed Pharmaceuticals (Nasdaq: GLMD) has announced groundbreaking findings regarding pharmacodynamic blood markers for Aramchol, their leading SCD1 inhibitor. The analysis of blood samples from the Phase 3 ARMOR MASH study revealed a panel of 70 proteins that form a distinctive pharmacodynamic signature after 12 weeks of treatment.
The study, conducted in collaboration with Proteas Health, demonstrated that Aramchol treatment led to:
- Decreased markers of chronic systemic inflammation
- Reduced oxidative and cardiac stress
- Lower atherosclerotic plaque pathogenesis
- Significant reduction in ANP (Atrial Natriuretic Peptide)
- Stimulated expression of KDM4C, a protein that represses liver fibrosis
The companies are developing a cost-efficient, high-throughput assay to measure Aramchol's pharmacodynamic signature, which could streamline future clinical trials and enable real-time evaluation of drug response.
Galmed Pharmaceuticals (Nasdaq: GLMD) ha annunciato scoperte rivoluzionarie riguardo ai marcatori farmacodinamici nel sangue per Aramchol, il loro principale inibitore di SCD1. L'analisi dei campioni di sangue dello studio di Fase 3 ARMOR MASH ha rivelato un pannello di 70 proteine che costituiscono una firma farmacodinamica distintiva dopo 12 settimane di trattamento.
Lo studio, condotto in collaborazione con Proteas Health, ha dimostrato che il trattamento con Aramchol ha portato a:
- Diminuzione dei marcatori di infiammazione sistemica cronica
- Riduzione dello stress ossidativo e cardiaco
- Minore patogenesi della placca aterosclerotica
- Significativa riduzione dell'ANP (Peptide Natriuretico Atriale)
- Stimolazione dell'espressione di KDM4C, una proteina che reprime la fibrosi epatica
Le aziende stanno sviluppando un test efficiente e ad alto rendimento per misurare la firma farmacodinamica di Aramchol, che potrebbe semplificare i futuri trial clinici e permettere una valutazione in tempo reale della risposta al farmaco.
Galmed Pharmaceuticals (Nasdaq: GLMD) ha anunciado hallazgos innovadores sobre marcadores farmacodinámicos en sangre para Aramchol, su principal inhibidor de SCD1. El análisis de muestras de sangre del estudio de Fase 3 ARMOR MASH reveló un panel de 70 proteínas que forman una firma farmacodinámica distintiva tras 12 semanas de tratamiento.
El estudio, realizado en colaboración con Proteas Health, demostró que el tratamiento con Aramchol condujo a:
- Disminución de marcadores de inflamación sistémica crónica
- Reducción del estrés oxidativo y cardíaco
- Menor patogénesis de placas ateroscleróticas
- Reducción significativa del ANP (Péptido Natriurético Auricular)
- Estimulación de la expresión de KDM4C, una proteína que reprime la fibrosis hepática
Las compañías están desarrollando un ensayo rentable y de alto rendimiento para medir la firma farmacodinámica de Aramchol, lo que podría agilizar futuros ensayos clínicos y permitir la evaluación en tiempo real de la respuesta al medicamento.
Galmed Pharmaceuticals (나스닥: GLMD)는 주요 SCD1 억제제인 Aramchol의 약력학적 혈액 마커에 관한 획기적인 발견을 발표했습니다. 3상 ARMOR MASH 연구에서 채취한 혈액 샘플 분석 결과, 12주 치료 후 독특한 약력학적 서명을 형성하는 70개의 단백질 패널이 확인되었습니다.
Proteas Health와 협력하여 진행된 이 연구는 Aramchol 치료가 다음과 같은 효과를 나타냄을 보여주었습니다:
- 만성 전신 염증 마커 감소
- 산화 및 심장 스트레스 감소
- 동맥경화 플라크 병인 감소
- ANP(심방 나트륨 이뇨 펩타이드) 유의미한 감소
- 간 섬유증을 억제하는 단백질인 KDM4C 발현 촉진
양사는 Aramchol의 약력학적 서명을 측정할 수 있는 비용 효율적이고 고처리량의 분석법을 개발 중이며, 이는 향후 임상시험을 간소화하고 약물 반응을 실시간으로 평가할 수 있게 할 것입니다.
Galmed Pharmaceuticals (Nasdaq : GLMD) a annoncé des découvertes révolutionnaires concernant les marqueurs pharmacodynamiques sanguins pour Aramchol, leur principal inhibiteur de SCD1. L'analyse des échantillons sanguins de l'étude de phase 3 ARMOR MASH a révélé un panel de 70 protéines formant une signature pharmacodynamique distinctive après 12 semaines de traitement.
L'étude, réalisée en collaboration avec Proteas Health, a démontré que le traitement par Aramchol entraînait :
- Une diminution des marqueurs d'inflammation systémique chronique
- Une réduction du stress oxydatif et cardiaque
- Une moindre pathogenèse des plaques athéroscléreuses
- Une réduction significative du peptide natriurétique atrial (ANP)
- Une stimulation de l'expression de KDM4C, une protéine qui réprime la fibrose hépatique
Les sociétés développent un test économique et à haut débit pour mesurer la signature pharmacodynamique d'Aramchol, ce qui pourrait faciliter les futurs essais cliniques et permettre une évaluation en temps réel de la réponse au médicament.
Galmed Pharmaceuticals (Nasdaq: GLMD) hat bahnbrechende Erkenntnisse zu pharmakodynamischen Blutmarkern für Aramchol, ihren führenden SCD1-Inhibitor, bekannt gegeben. Die Analyse von Blutproben aus der Phase-3-ARMOR-MASH-Studie zeigte ein Panel von 70 Proteinen, die nach 12 Wochen Behandlung eine charakteristische pharmakodynamische Signatur bilden.
Die Studie, die in Zusammenarbeit mit Proteas Health durchgeführt wurde, zeigte, dass die Behandlung mit Aramchol zu folgenden Effekten führte:
- Verminderte Marker chronischer systemischer Entzündungen
- Reduzierter oxidativer und kardialer Stress
- Geringere Entstehung von atherosklerotischen Plaques
- Signifikante Reduktion von ANP (atriales natriuretisches Peptid)
- Stimulierte Expression von KDM4C, einem Protein, das Leberfibrose hemmt
Die Unternehmen entwickeln einen kosteneffizienten, hochdurchsatzfähigen Test zur Messung der pharmakodynamischen Signatur von Aramchol, der zukünftige klinische Studien vereinfachen und eine Echtzeitbewertung der Arzneimittelreaktion ermöglichen könnte.
- Discovery of 70 protein markers validates Aramchol's mechanism of action
- Development of cost-efficient blood test could accelerate clinical trials
- Potential expansion into additional therapeutic areas beyond NASH/MASH
- Demonstrated efficacy in reducing multiple disease markers
- Partnership with Proteas Health for assay development
- Clinical validation of new biomarkers still required
- Timeline for high-throughput assay development not specified
- Additional studies needed to confirm expansion into new therapeutic areas
Insights
Galmed's announcement on Aramchol's pharmacodynamic markers represents an important clinical development milestone but with measured significance. By identifying a 70-protein panel in their Phase 3 ARMOR study, they've created a potential liquid biopsy that could serve as an early efficacy indicator for their SCD1 inhibitor.
The findings reveal Aramchol's broader mechanism beyond NASH treatment, showing effects on systemic inflammation, oxidative stress, and atherosclerotic processes - key drivers in cardiometabolic diseases. The significant reduction in ANP (Atrial Natriuretic Peptide) is particularly noteworthy as it's a validated marker for heart failure.
From a clinical development perspective, this represents a potential de-risking event. Having biomarkers that track drug response could optimize patient selection and potentially predict outcomes earlier than liver biopsies in future trials. The stimulated expression of KDM4C, which suppresses liver fibrosis, aligns with Aramchol's intended therapeutic purpose.
However, these are surrogate markers rather than clinical endpoints. While they suggest potential expansion into cardiovascular indications, this remains speculative until validated in properly designed trials. The collaboration with Proteas Health to develop a high-throughput assay could accelerate this validation, but commercialization remains distant.
For a micro-cap biotech developing NASH treatments - an area with significant clinical development challenges - these biomarker discoveries provide scientific validation and potential pathways to expand Aramchol's utility, though regulatory approval hurdles remain substantial.
This biomarker development represents a strategic pivot that moderately enhances Galmed's commercial positioning without fundamentally changing near-term prospects. With a micro-cap valuation of $3M, Galmed clearly needs differentiation factors in the competitive NASH/MASH landscape.
The identified pharmacodynamic signature offers three potential business advantages: First, it creates a companion diagnostic opportunity that could improve patient selection in future trials. Second, it opens expansion possibilities into cardiometabolic indications - a substantially larger market than NASH alone. Third, it provides a potential licensing opportunity for their biomarker panel independent of Aramchol's approval.
However, this announcement doesn't change the fundamental reality that Aramchol remains in clinical development without proven efficacy on regulatory-approved endpoints. The company didn't disclose plans for additional funding required to pursue these expanded indications, a critical consideration given their size.
The partnership with Proteas Health follows the industry trend of utilizing biomarkers to de-risk development, but commercialization requires significant additional investment. While the scientific findings are promising, Galmed still faces the substantial challenge of completing Phase 3 development and securing regulatory approval.
The market opportunity in cardiometabolic disease is substantial, but expanding into this area would necessitate considerable additional resources and likely partnership with larger pharmaceutical companies. This announcement represents incremental scientific progress rather than a transformational commercial breakthrough.
- Analysis of blood samples from patients treated with Aramchol in ARMOR (Ph3 MASH Study) provides new and important insights into the biochemical and physiological effects of the drug.
- The pharmacodynamic signature associated with Aramchol treatment revealed a decrease in markers of chronic systemic inflammation, oxidative and cardiac stress, and atherosclerotic plaque pathogenesis.
- Data also show a significant decrease in ANP (Atrial Natriuretic Peptide), a clinically validated marker for heart failure.
In collaboration with Proteas Health, a leader in innovative protein biomarker and targeted assay development, Galmed has pinpointed plasma markers that track Aramchol's therapeutic impact through cutting-edge proteomics and AI technologies. Specifically, a panel of 70 proteins expressed at Week 12 of Aramchol treatment (compared with baseline) was captured in the Company's Phase 3 ARMOR MASH study. This panel forms an actionable, single blood-based pharmacodynamic signature to monitor and potentially predict patient response, encompassing both systemic and local (liver) effects.
Galmed's analysis revealed that this signature aligns with reduced chronic systemic inflammation, oxidative stress, and atherosclerotic plaque pathogenesis—key drivers in cardiometabolic diseases. Significantly, the data also demonstrate a marked reduction in ANP (Atrial Natriuretic Peptide), widely recognized as an established clinical biomarker for heart failure and left ventricular dysfunction. Moreover, the findings indicate a stimulated expression of KDM4C, a protein known to play a role in repressing liver fibrosis. Altogether, these insights underscore Aramchol's broad therapeutic relevance and create valuable opportunities for Galmed to expand its clinical pipeline and address additional cardiometabolic and potentially oncological indications.
Allen Baharaff, CEO of Galmed Pharmaceuticals commented: "The newly discovered markers showed significant expression in untreated patients at baseline and were reversed following treatment with Aramchol. These PD markers could serve as a liquid biopsy as an early indicator of Aramchol's efficacy in clinical settings. Additionally, the observed significant effects on cardiometabolic biomarkers open future research avenues for Aramchol in CVD and related conditions".
The collaboration with Proteas Health aims to translate these discoveries into a streamlined, cost-efficient, high-throughput assay that directly measures Aramchol's unique PD signature. Such an assay, once validated, could bolster Galmed's forthcoming clinical trials by further de-risking development and allowing clinicians to evaluate drug response in real time.
"Through this collaboration, Proteas Health and Galmed aim to develop a cost-effective, high-throughput assay targeting Aramchol's unique pharmacodynamic signature. This assay could play a pivotal role in Galmed's future clinical trials, accelerating the efforts to bring Aramchol to market" said Dr. Antigoni Manousopoulou, MD, PhD, Co-Founder and Chief Scientific Officer at Proteas Health. "By focusing on targeted pharmacodynamic biomarkers, Proteas Health is not just enhancing drug development Proteas Health ensuring therapies are tailored to achieve maximum benefit with minimal risk."
These promising data underscore Galmed's growing momentum: by combining innovative biomarker strategies with Aramchol's safety and efficacy profile, the Company believes it is well-positioned to broaden its market reach and deliver significant value to patients and stakeholders alike. Given the global burden of cardiometabolic and fibro-inflammatory conditions, the ability to demonstrate and monitor Aramchol's impact through a single blood test has the potential to transform future clinical development and create new horizons for commercialization.
About Galmed Pharmaceuticals Ltd.
Galmed Pharmaceuticals Ltd. is a biopharmaceutical company focused on the development of Aramchol. The Company has concentrated almost exclusively on advancing Aramchol for the treatment of liver disease and is currently pursuing development of Aramchol in oncological indications beyond NASH and fibrosis. As part of its growth strategy, Galmed is actively exploring opportunities to expand and diversify its product pipeline—particularly in cardiometabolic indications and other innovative product candidates aligned with the Company's core drug-development expertise.
About Proteas Health
Proteas Health has pioneered a cutting-edge liquid biopsy platform technology to identify and analyze proteins as pharmacodynamic signatures of drug mechanisms in specific diseases. By enabling pharmaceutical companies to verify safety and efficacy profiles—including proof of mechanism—Proteas Health's solutions are designed to reduce clinical trial risk and accelerate pathways to commercialization, making it an integral partner in modern drug development.
Forward-Looking Statements:
Forward-looking statements relate to anticipated or expected events, activities, trends or results as of the date they are made. Because forward-looking statements relate to matters that have not yet occurred, these statements are inherently subject to risks and uncertainties that could cause our actual results to differ materially from any future results expressed or implied by the forward-looking statements. Forward-looking statements may include, but are not limited to, statements relating to our product development efforts, business, financial condition, results of operations, strategies or prospects, including the potential of the PD markers for Aramchol, as well as statements, other than historical facts, that address activities, events or developments that we intend, expect, project, believes or anticipate will or may occur in the future. Many factors could cause our actual activities or results to differ materially from the activities and results anticipated in forward-looking statements, including, but not limited to, the development and approval of the use of Aramchol or any other product candidate for indications outside of non-alcoholic steatohepatitis, or NASH, also known as metabolic dysfunction-associated steatohepatitis, or MASH, and fibrosis or in combination therapy; the timing and cost of any pre-clinical or clinical trials of Aramchol or any other product candidate we develop; completion and receiving favorable results of any pre-clinical or clinical trial; regulatory action with respect to Aramchol or any other product candidate by the
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