The idea behind Aphaia Pharma is to treat metabolic disease early enough that patients don’t progress to a type 2 diabetes diagnosis.
The company is developing an oral glucose treatment targeting prediabetes, a condition that occurs when blood glucose levels are higher than normal but not high enough to be type 2 diabetes. And in Phase 2 data released Thursday, APHD-012 hit the primary endpoint, showing a statistically significant improvement in glucose tolerance compared to placebo.
In the six-week study, the drug reduced blood sugar levels in 30 participants, including patients who are healthy, have prediabetes and have type 2 diabetes. No serious adverse events occurred during the study.
APHD-012 works at a particular part of the end of the small intestine called the distal jejunum. A common denominator of metabolic diseases is that the distal small intestine and its nutrient-sensing cells are no longer exposed to food due to slower digestion, according to Aphaia co-founder and CSO Steffen-Sebastian Bolz.
When Aphaia’s drug is released, it restores the ability of the cells to sense nutrients and stimulate the release of hormones that control appetite and glucose metabolism, like GLP-1s.
Bolz told Endpoints News that one of the biggest problems is that 70% of prediabetic patients progress to diabetes within a year. Aphaia’s goal is to prevent that progression.
“That’s what we thought about when we had those discussions with the regulatory authorities and it dawned on us that this might be a very interesting concept that we could actually target with our drug and our mechanism of action,” Bolz said. “This is why we did this rather small study to show that we could indeed delay the onset of progression.”
APHD-012 is also being tested for obesity. It’s currently in a Phase 2 trial in patients with obesity, and data are expected in the second half of this year. There are two cohorts in the trial; one group takes the drug once a day, and another takes it twice a day.
“We have a very, very physiological mechanism,” Bolz added. “We know that it increases satiety, reduces hunger and so on, and applying this at two times per day might be very powerful to actually delay and prevent late eating and all these kinds of phenomena.”