US-based clinical-stage biopharmaceutical company Aerpio Therapeutics has begun its Phase Ia clinical trial of AKB-4924 to treat inflammatory bowel disease (IBD).
AKB-4924 is a small molecule, orally administered on a once-daily basis and has been developed as a hypoxia inducible factor 1 alpha (HIF-1α) stabilising agent.
HIF-1α is considered important for the regulation of innate immune responses and maintenance of epithelial barrier function, particularly in the gut.
The randomised, double-blind, placebo-controlled Phase Ia trial is planning to enrol up to 48 healthy volunteers.
The trial is primarily focused on testing the safety and tolerability of AKB-4924 when administered in a single dose.
It will also assess the pharmacokinetics and pharmacodynamics profile of AKB-4924.
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Aerpio chief scientific officer Kevin Peters said: “Initiating the clinical development programme for AKB-4924 represents a major milestone.
“AKB-4924 has the potential to be the first orally administered agent to target both the resolution of inflammation and the restoration of epithelial barrier function, the two major drivers of IBD pathogenesis.”
Aerpio CEO believes that AKB-4924 can lead to a reduced dependence of IBD patients on steroids or biologics, which poses significant side effects.
AKB-4924 has demonstrated its efficacy in reducing disease activity, with decreased levels of inflammation and preservation of mucosal integrity in multiple in vivo preclinical models of IBD.