Galmed Announces Positive Part 1 Results from the AM-001 Study of Aramchol Meglumine, an Enhanced Formulation of the Most Clinically Advanced SCD1 Inhibitor
Galmed Pharmaceuticals (NASDAQ: GLMD) has announced positive preliminary results from Part 1 of the Ph1 Bioavailability AM-001 Study for Aramchol Meglumine, an enhanced formulation of their lead compound.
Key findings show that 400 mg of Aramchol Meglumine suspension achieved nearly double the area under the curve (AUC) compared to Aramchol acid tablets. The study suggests that a 200 mg once-daily oral dose will be optimal for future trials, improving patient compliance and potentially reducing manufacturing costs.
Aramchol Meglumine, granted NCE patent protection until 2035, demonstrates enhanced solubility, absorption, and systemic exposure compared to Aramchol acid. The FDA has approved the transition from Aramchol acid to Aramchol Meglumine under a new IND, with Part 2 of the study expected to conclude in H2 2025.
Galmed Pharmaceuticals (NASDAQ: GLMD) ha annunciato risultati preliminari positivi dalla Parte 1 dello studio di bioavailability Ph1 AM-001 per Aramchol Meglumine, una formulazione migliorata del loro composto principale.
I risultati chiave mostrano che la sospensione di Aramchol Meglumine da 400 mg ha raggiunto quasi il doppio dell'area sotto la curva (AUC) rispetto alle compresse di acido Aramchol. Lo studio suggerisce che una dose orale giornaliera di 200 mg sarà ottimale per i futuri trial, migliorando l'aderenza dei pazienti e potenzialmente riducendo i costi di produzione.
Aramchol Meglumine, protetto da brevetto NCE fino al 2035, dimostra una solubilità, un'assorbimento e un'esposizione sistemica migliorati rispetto all'acido Aramchol. La FDA ha approvato la transizione dall'acido Aramchol ad Aramchol Meglumine sotto un nuovo IND, con la Parte 2 dello studio prevista per concludersi nel secondo semestre del 2025.
Galmed Pharmaceuticals (NASDAQ: GLMD) ha anunciado resultados preliminares positivos de la Parte 1 del estudio de bio disponibilidad Ph1 AM-001 para Aramchol Meglumina, una formulación mejorada de su compuesto principal.
Los hallazgos clave muestran que la suspensión de Aramchol Meglumina de 400 mg logró casi el doble del área bajo la curva (AUC) en comparación con las tabletas de ácido Aramchol. El estudio sugiere que una dosis oral diaria de 200 mg será óptima para futuros ensayos, mejorando la adherencia del paciente y potencialmente reduciendo los costos de fabricación.
Aramchol Meglumina, protegido por patente NCE hasta 2035, demuestra una solubilidad, absorción y exposición sistémica mejoradas en comparación con el ácido Aramchol. La FDA ha aprobado la transición del ácido Aramchol a Aramchol Meglumina bajo un nuevo IND, y se espera que la Parte 2 del estudio concluya en el segundo semestre de 2025.
Galmed Pharmaceuticals (NASDAQ: GLMD)는 Aramchol Meglumine에 대한 Ph1 생체이용률 AM-001 연구의 1부에서 긍정적인 초기 결과를 발표했습니다. Aramchol Meglumine은 그들의 주요 화합물의 개선된 제형입니다.
주요 결과는 400mg의 Aramchol Meglumine 현탁액이 Aramchol 산 정제에 비해 곡선 아래 면적(AUC)을 거의 두 배로 달성했다는 것을 보여줍니다. 이 연구는 하루 한 번 200mg의 경구 투여량이 향후 시험에 최적일 것이라고 제안하며, 환자의 순응도를 개선하고 제조 비용을 잠재적으로 줄일 수 있습니다.
Aramchol Meglumine은 2035년까지 NCE 특허 보호를 받으며, Aramchol 산에 비해 개선된 용해도, 흡수 및 전신 노출을 보여줍니다. FDA는 새로운 IND에 따라 Aramchol 산에서 Aramchol Meglumine으로의 전환을 승인했으며, 연구의 2부는 2025년 하반기에 종료될 것으로 예상됩니다.
Galmed Pharmaceuticals (NASDAQ: GLMD) a annoncé des résultats préliminaires positifs de la Partie 1 de l'étude de biodisponibilité Ph1 AM-001 pour Aramchol Meglumine, une formulation améliorée de leur composé principal.
Les résultats clés montrent que la suspension d'Aramchol Meglumine à 400 mg a atteint presque le double de l'aire sous la courbe (AUC) par rapport aux comprimés d'acide Aramchol. L'étude suggère qu'une dose orale quotidienne de 200 mg sera optimale pour les futurs essais, améliorant l'adhérence des patients et réduisant potentiellement les coûts de fabrication.
Aramchol Meglumine, protégé par un brevet NCE jusqu'en 2035, démontre une solubilité, une absorption et une exposition systémique améliorées par rapport à l'acide Aramchol. La FDA a approuvé la transition de l'acide Aramchol vers Aramchol Meglumine sous un nouvel IND, la Partie 2 de l'étude devant se terminer au second semestre 2025.
Galmed Pharmaceuticals (NASDAQ: GLMD) hat positive vorläufige Ergebnisse aus Teil 1 der Ph1-Bioverfügbarkeitsstudie AM-001 für Aramchol Meglumine, eine verbesserte Formulierung ihres Hauptverbindung, bekannt gegeben.
Wichtige Ergebnisse zeigen, dass die 400 mg Aramchol Meglumine Suspension fast das Doppelte der Fläche unter der Kurve (AUC) im Vergleich zu Aramchol-Säure-Tabletten erreichte. Die Studie legt nahe, dass eine 200 mg einmal täglich orale Dosis optimal für zukünftige Studien sein wird, die Patienteneinhaltung verbessert und potenziell die Herstellungskosten senkt.
Aramchol Meglumine, das bis 2035 durch ein NCE-Patent geschützt ist, weist im Vergleich zur Aramchol-Säure eine verbesserte Löslichkeit, Absorption und systemische Exposition auf. Die FDA hat den Übergang von Aramchol-Säure zu Aramchol Meglumine unter einem neuen IND genehmigt, wobei der Teil 2 der Studie voraussichtlich im zweiten Halbjahr 2025 abgeschlossen sein wird.
- New formulation shows double bioavailability compared to previous version
- Patent protection secured until 2035
- FDA approved transition to new formulation under new IND
- Simplified dosing from twice-daily to once-daily
- Potential reduction in manufacturing costs
- Phase 1 study still ongoing with Part 2 results pending
- Commercial launch timeline not specified
Insights
Galmed's positive preliminary results from Part 1 of the AM-001 bioavailability study represent a significant formulation improvement for their lead compound. The development of Aramchol Meglumine delivers three tangible advantages over the previous free acid version:
First, the enhanced bioavailability is substantial - a 400mg dose achieved nearly double the area under the curve compared to Aramchol acid tablets. This pharmacokinetic improvement enables the shift to a more convenient once-daily 200mg dosing schedule from the previous twice-daily regimen.
Second, Aramchol Meglumine's NCE designation with patent protection until 2035 provides critical long-term market exclusivity, significantly extending Galmed's commercial runway compared to the original formulation.
Third, the simplified dosing regimen and potential manufacturing cost reductions improve the commercial profile for both patients and the company.
This formulation advancement represents a necessary FDA-required bridge between Galmed's extensive existing clinical data (six completed trials with 661 subjects through Phase 3) and their planned expansion into additional indications. The successful completion of Part 1 keeps their clinical timeline on track, with Part 2 results expected in H2 2025.
While this represents a positive technical milestone rather than efficacy data for new indications, it removes a key regulatory hurdle and enhances Aramchol's development potential across multiple therapeutic areas.
– AM-001 Study represents a pivotal milestone in Galmed's transition to Aramchol Meglumine, an improved formulation of its lead compound in advanced clinical development
– Aramchol Meglumine, a New Chemical Entity (NCE) protected by patents until 2035, is being developed both as a standalone agent and in novel drug combinations for multiple indications influenced by fatty acid metabolism
– Initial findings suggest that the new Aramchol Meglumine formulation offers higher bioavailability than Aramchol free acid and that a once-daily, oral 200 mg dose is likely to be optimal for future trials, supporting improved patient compliance and potentially lowering manufacturing costs
Galmed has successfully advanced Aramchol acid through six clinical trials (up to Ph3) enrolling 661 subjects, establishing both its overall safety and its efficacy in treating NASH (MASH). The N-methylglucamine (meglumine) salt of Aramchol exhibits notable advantages over Aramchol acid, including enhanced solubility, absorption, and systemic exposure, translating to higher bioavailability. In recognition of these benefits, Aramchol Meglumine received NCE patent protection extending until 2035.
Previously, the FDA approved the transition from Aramchol acid to Aramchol Meglumine under a new IND, leveraging cross-reference to the substantial preclinical and clinical data amassed in recent years for Aramchol. The only requirement for this transition was a bioavailability study to compare the two formulations.
The AM-001 study was conducted in response to that FDA request and is also designed to help identify the doses best suited for advancing Aramchol Meglumine into Phase 2 studies. It consists of two parts, comparing single doses of Aramchol acid and Aramchol Meglumine in healthy volunteers. Part 2 of the study is anticipated to conclude in the second half of 2025.
In Part 1 of AM-001, preliminary results demonstrate that a 400 mg dose of Aramchol Meglumine suspension achieved an area under the curve (AUC) nearly double that of Aramchol acid tablets. Based on these outcomes, 200 mg once daily appears to be the optimal dose for subsequent clinical trials. This once-daily regimen not only simplifies patient adherence (moving from twice-daily to once-daily) but is also expected to reduce the overall cost of goods.
"Aramchol is the most advanced down regulator of SCD-1 (Stearoyl – CoA desaturase) in clinical development. Inhibition of SCD-1 has been recently investigated in multiple indications, re-emphasizing its metabolic master switch potential and importance in multiple organs and functions. We expect that the long patent runway of Aramchol Meglumine will allow us to develop the full therapeutical potential of the drug in the planned expansion in cardiometabolic diseases and gastrointestinal cancers we recently announced," said Allen Baharaff, President and CEO of Galmed Pharmaceuticals.
These latest Part 1 data reinforce Galmed's commitment to accelerating Aramchol Meglumine's clinical program. As seen with other biopharmaceutical companies that have successfully introduced improved formulations—often resulting in increased market interest—Galmed believes that Aramchol Meglumine's enhanced bioavailability, once-daily dosing, and robust patent protection position the Company favorably for continued growth. By building on its strong clinical foundation, Galmed aims to deliver innovative therapies for patients with significant unmet medical needs, while responsibly driving value for stakeholders.
About Galmed Pharmaceuticals Ltd.
We are a biopharmaceutical company focused on the development of Aramchol. We have focused almost exclusively on developing Aramchol for the treatment of liver disease and we are currently seeking to advance the development of Aramchol for oncological indications outside of NASH and fibrosis. In addition, as part of our growth strategy, we are actively pursuing opportunities to expand and diversify our product pipeline specifically targeting cardiometabolic indications and other innovative product candidates that align with our core expertise in 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 timing of completion of the AM 001 study, 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
capital requirements and our needs for additional financing; market adoption of Aramchol or any other product candidate by physicians and patients; the timing, cost or other aspects of the commercial launch of Aramchol or any other product candidate; our ability to obtain and maintain adequate protection of our intellectual property; the possibility that we may face third-party claims of intellectual property infringement; our ability to manufacture our product candidates in commercial quantities, at an adequate quality or at an acceptable cost; our ability to establish adequate sales, marketing and distribution channels; intense competition in our industry, with competitors having substantially greater financial, technological, research and development, regulatory and clinical, manufacturing, marketing and sales, distribution and personnel resources than we do; our expectations regarding licensing, acquisitions and strategic operations; current or future unfavorable economic and market conditions and adverse developments with respect to financial institutions and associated liquidity risk; our ability to maintain the listing of our ordinary shares on The Nasdaq Capital Market; and security, political and economic instability in the
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FAQ
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