Galmed Pharmaceuticals’ synthetic small molecule candidate, aramchol, has proven to be a powerful tool in the fight against non-alcoholic steatohepatitis (NASH), following Phase III ARMOR trial results. This groundbreaking development shows that the drug can effectively improve the presence of fibrosis in those suffering from the condition.
ARMOR’s open-label phase revealed that after 48 weeks of aramchol treatment, an impressive 39% of patients showed improvements in fibrosis, as assessed by the NASH Clinical Research Network scoring system. But the results were even more impressive when pathologists compared biopsies from before and after treatment – a whopping 61% of patients demonstrated improvements!
On Wednesday, investors were delighted as Galmed’s stock rose by as much as 17% as a result of a new AI-assisted digital pathology reading approach. This technique found that 100% of aramchol-treated patients experienced a fibrosis improvement of at least 0.3 points in the Fibrosis Composite Severity score. This data was a cause for celebration in the medical and financial community alike.
The findings of the ARMOR study, achieved through meticulous pathology reading methodology with three independent readers, reveal the remarkable clinical benefit of aramchol. Prof. Vlad Ratziu, co-principal investigator of ARMOR, noted that the efficacy parameters of aramchol showed remarkable improvement over time.
Aramchol stands out from other NASH treatment candidates due to its unique mechanism of action, impressive effects, and impressive safety profile. These qualities could position it as one of the leading treatments for patients with NASH.
Galmed’s Phase III ARMOR trial is a two-part study; firstly an open-label phase, and then a randomized, placebo-controlled phase. In May last year, the open-label phase of ARMOR showed that aramchol could provide consistent anti-fibrotic effects in patients with NASH. Excitingly, this could mark the start of a new era for the treatment of this serious condition.
The second phase of ARMOR is set to enroll a whopping 2,000 patients with stage 2 and 3 NASH-related liver fibrosis, with a 2:1 ratio of those receiving aramchol versus a placebo. In May, however, Galmed announced that it was discontinuing the open-label phase of the study.
Galmed made the strategic decision to expand the clinical development of aramchol into other anti-fibrotic indications, with the aim of providing a fast-tracked regulatory approval and maximizing the potential of the drug. This bold move is expected to make the best use of company resources and potentially pave the way for a brighter future.
Galmed has no intention of initiating ARMOR’s double-blinded portion, according to Allen Baharaff, the company’s co-founder, president and CEO. Baharaff believes that Galmed is on the right path and that the current approach should remain unchanged.
NASH Space Heats Up
In the past few weeks, the NASH drug development landscape has been abuzz with promising news. On Tuesday, Israeli biotech ChemomAb reported positive results from a Phase IIa clinical trial of its CM-101 monoclonal antibody, which showed signs of efficacy in reducing liver fibrosis biomarkers and stiffness when administered subcutaneously. The next day, SFA Therapeutics received FDA clearance for its Investigational New Drug application for SFA-001N, a potential NASH treatment that works on multiple pathways. And last December, Madrigal Pharmaceuticals unveiled positive Phase III data for its thyroid hormone receptor agonist resmetirom in NASH patients.