In a late breaking clinical trial at ACG 2019, investigators say AK002 shows promise in treating patients with EGID.
While there is not a medication approved by US Food and Drug Administration (FDA) to treat Eosinophilic gastrointestinal (GI) disorders (EGIDs) such as eosinophilic gastritis (EG) and gastroenteritis (EGE), investigators are hopeful 1 is on the way.
In a late breaking abstract from a phase 2 trial presented at the American College of Gastroenterology’s Annual Scientific Meeting (ACG 2019), Evan Dellon, MD, University of North Carolina School of Medicine, said AK002 could be the answer to treat these rare gastrointestinal disorders.
In an interview with MD Magazine®, Dellon explained there is currently a lack of viable treatment options for EGIDs and how AK002 could change the game and ultimately help these patients.
MD Mag: Can you explain the impetus behind the late breaking clinical trial presented at ACG 2019.
Dellon: So, this medicine is a very novel medicine. It's a humanized monoclonal antibody and it targets a receptor called siglec-8 and this is a receptor that's highly specific to mast cells in the eosinophils.
When the medication interacts with this receptor it creates an inhibitory signal and that leads to mast cell inactivation.
It's highly anti-inflammatory and both of those are important effector cells in eosinophilic gastritis and gastroenteritis.
So, in this trial it was given to patients with moderate to severe symptoms of EG or EGE and highly active inflammation on biopsies. It was a 12-week treatment course and it's an IV infusion right now.
Patients received either active dose, either a high dose or a low dose compared to placebo. After 12 weeks, the outcomes were assessed and so the real impetus was to show proof of principle that this worked.
Another interesting part of the study was in addition to seeing the excellent outcomes where the study did meet the primary and secondary outcomes with eosinophilic gastritis and gastroenteritis, there was a subset of the population that also had esophageal involvement.
So, they essentially had a EoE as well and we also saw decrease in eosinophil counts in the esophagus in those patients and decreases in dysphasia symptoms too. So, it looks like it may be a promising medication for both conditions.
MD Mag: Why hasn't there been an FDA approved treatment for eosinophilic gastrointestinal disorders?
Dellon: Well in this particular condition, the eosinophilic gastritis and gastroenteritis, it's really a very rare condition. There may be right now we think about 50,000 people in the US who have this condition.
So there just haven't been any real prospective studies or clinical trials. Right now, the current standard of care is people are administered with corticosteroids or they do dietary elimination but neither of those are optimally effective.
So, this is one of the first medications that's actually been applied just to this condition. So, it's the first one to go through this approval pathway.
I think for the other eosinophilic GI disorders like EoE it's just been a long the process of learning exactly what's required for FDA approval and in particular getting symptom measures and patient reported outcomes validated so we can use those in clinical trials.