Hollis-Eden requests approval of metabolic drug trial

30th March 2007: Hollis-Eden Pharmaceuticals has filed an investigational new drug application with the FDA to begin a phase I trial with its drug candidate for the treatment of metabolic disorders, which include diabetes, obesity and dyslipidemia.
The phase I trial program, designed to assess the safety of the drug candidate HE3286, could support both a phase II study in type 2 diabetes patients, as well as a phase II study in rheumatoid arthritis patients.

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.

As previously reported, HE3286 produced glucose lowering activity and increased insulin sensitivity when administered orally in preclinical models of type 2 diabetes. The company's findings suggest that HE3286 may be the first in a new class of insulin sensitizers, 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 being prescribed. By working through this new pathway, HE3286 appears to avoid the side effect of weight gain commonly seen with existing therapies.

HE3286 has also demonstrated a dramatic 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. Treg cells play a key role in keeping the immune system from attacking the body itself.

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