Action Pharma reports positive results in a proof of concept phase IB study in obese human volunteers treated with AP1030
Action Pharma A/S has completed a proof of concept clinical phase IB study with AP1030 currently being developed for treatment of type II diabetes associated with obesity. In a phase IB study the effect of AP1030 on glucose metabolism in obese human volunteers was investigated. AP1030 administered orally once-daily for two weeks in obese human volunteers significantly improved glucose metabolism.
AP1030 is the first in a new drug class developed for oral once-daily treatment based on a new mode of action (a positive allosteric modulator through new pharmacological targets, the melanocortin receptors) and is part of Action Pharma’s small molecule program. The mode of action of AP1030 involves a hypothalamic melanocortin type 4 receptor mediated effect, thereby modulating appetite and central regulation of glucose metabolism. In addition, AP1030 exerts anti-inflammatory effects mediated through melanocortin type 1 receptors aimed at reverting low grade inflammation in fatty tissues and thereby reducing peripheral insulin resistance.
“The positive results obtained for AP1030 in the phase IB study is a major milestone for Action Pharma”, says Ingelise Saunders, CEO of Action Pharma, and continues: “In contrast to other weight reducing anti-diabetics, including GLP-1 analogues, AP1030 has the major advantage of being administered once-daily orally potentially making it very attractive for the anti-diabetes market.”
The clinical phase IB trial investigating the effect of AP1030 in obese human volunteers was conducted in Paris, France, at SGS Aster’s phase I unit. The study was a randomized, doubleblind placebo-controlled dose escalation study. A total of 50 obese volunteers with a body mass index larger than 30, were enrolled in 5 cohorts.
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