Galmed announces positive late-stage results in biopsy-proven NASH patients.
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Follow-up results from the Phase III ARMOR trial show Galmed Pharmaceuticals’ synthetic small molecule candidate aramchol improves fibrosis in non-alcoholic steatohepatitis (NASH) patients, the Israel-based biopharma reported Wednesday.
These data come from ARMOR’s open-label phase, which saw that after at least 48 weeks of aramchol treatment, 39% of patients demonstrated fibrosis improvement, as assessed by the NASH Clinical Research Network scoring system. When pathologists compared biopsies from before vs after treatment, they found 61% of patients showed such improvements.
Meanwhile, an AI-assisted digital pathology reading approach found that at a pre-specified reduction of at least 0.3 points in the Fibrosis Composite Severity score, 100% of aramchol-treated patients met the criteria for fibrosis improvement.
Galmed’s stock rose by as much as 17% Wednesday following the data drop.
In a prepared statement, Prof. Vlad Ratziu, co-principal investigator of ARMOR said that these findings, obtained through “extremely rigorous pathology reading methodology with three independent readers,” demonstrate the clinical benefit of aramchol “across all efficacy parameters with improvement over time.”
“The type and magnitude of effects we see with aramchol compared to other NASH candidates, together with its unique mechanism of action and safety, potentially position aramchol as a leading treatment for patients with NASH,” he added.
The Phase III ARMOR trial is designed to have two parts: an open-label phase followed by a randomized, double-blinded and placebo-controlled phase. Galmed had previously released data from ARMOR’s open-label phase in May last year, showing that aramchol elicits consistent anti-fibrotic effects in NASH patients.
As designed, the second phase of ARMOR is set to enroll some 2,000 NASH patients with stage 2 and 3 liver fibrosis, who would then be randomized in a 2:1 ratio to receive aramchol or matching placebo. However, along with the May release, Galmed announced that it was discontinuing the open-label phase of the study.
Instead, Galmed opted to expand the clinical development of aramchol into other anti-fibrotic indications, which the company believes would “provide a potentially faster development pathway for regulatory approval” and “maximize the potential of aramchol with better use of company resources.”
Galmed also has no plans of initiating ARMOR’s double-blinded part, according to Allen Baharaff, co-founder, president and CEO of Galmed.
NASH Space Heats Up
The last few weeks have been a busy time for NASH drug developers. On Tuesday, Galmed’s fellow Israeli biotech ChemomAb posted promising Phase IIa results for its investigational monoclonal antibody CM-101.
Subcutaneous dosing of the candidate was largely safe and showed signals of efficacy, leading to improvements in liver fibrosis biomarkers and liver stiffness.
The day after, Pennsylvania-based biopharma SFA Therapeutics announced that the FDA had cleared the Investigational New Drug application for SFA-001N, a NASH candidate that simultaneously acts on multiple pathways.
Additionally, Madrigal Pharmaceuticals announced positive Phase III data for its thyroid hormone receptor agonist resmetirom in NASH patients last December.
