The Phase I/II dose ranging study will evaluate the safety, tolerance, pharmacokinetics and activity of Triolex when administered orally for 28 days to patients with active, mild-to-moderate ulcerative colitis (UC). Triolex is a novel orally bio-available adrenal steroid hormone analogue with anti-inflammatory and insulin sensitizing properties currently in clinical trials under an open IND for the treatment of metabolic disorders.
The company has also been cleared under a separate IND with the FDA to begin clinical trials with Triolex for the treatment of rheumatoid arthritis (RA). A safety and pharmacokinetic phase I/II clinical trial in stable RA patients on methotrexate, a commonly used chemotherapy treatment, is currently planned to begin in the second quarter of 2008. The company believes that certain aspects of the pathology driving UC are similar to those driving RA and therefore, data obtained in this UC study could potentially help support the design of the company’s planned Phase II RA clinical study and accelerate the development of Triolex for potential use in patients with RA.
Richard Hollis, chairman and CEO of Hollis-Eden Pharmaceuticals, said: “This study may potentially enable us to demonstrate activity in humans with a short treatment course of Triolex in an acute inflammatory condition, and thereby accelerate its potential commercialization.”