Hollis-Eden Pharmaceuticals, Inc. filed an IND application with FDA to begin a Phase I trial with its next-generation drug candidate, HE3286, for the treatment of metabolic disorders, which include diabetes, obesity and dyslipidemia. The trial program, designed to assess the safety of HE3286 in healthy volunteers, could support both a Phase II study in type 2 diabetes, and a Phase II study in rheumatoid arthritis under a separate IND the company plans to file for autoimmune disorders later this year.
In preclinical studies, HE3286 has been shown to regulate signaling pathways of inflammation common to both metabolic and autoimmune disorders. In preclinical models of type 2 diabetes, HE3286 produced glucose lowering activity and increased insulin sensitivity when administered orally. These findings suggest that HE3286 may be the first in a new class of insulin sensitizers with a novel mechanism of action, since it appears to regulate the pro-inflammatory NF-kappa B pathway without acting on the PPARgamma receptor, which is the target of insulin sensitizing drugs currently prescribed today. This new pathway appears to avoid the side effect of weight gain commonly seen with these existing therapies.
HE3286 has also demonstrated a benefit in rodent models of both initial-onset and established rheumatoid arthritis. Potential mechanisms of action for HE3286 in this indication include regulation of NF-kappa B and increasing the production of regulatory T cells, or Treg cells, which play a key role in keeping the immune system from attacking the body.
Hollis-Eden Files IND for Phase I Trial in Metabolic Disorders
Published March 29, 2007
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