Hollis-Eden Commences Phase I/II Clinical Trial with TRIOLEX™ in Rheumatoid Arthritis Patients

Hollis-Eden Pharmaceuticals, Inc. has announced that it has commenced a Phase I/II open label dose ranging clinical trial with its investigational oral drug candidate TRIOLEX™ (HE3286) in patients diagnosed with rheumatoid arthritis (RA) and receiving a stable dose of methotrexate, the current standard of care in RA.

The purpose of the Phase I/II clinical trial is to evaluate the safety and tolerance of TRIOLEX when administered orally for 28 days at three different dose levels. The study will also evaluate the pharmacokinetics (PK) and metabolism profiles of methotrexate and TRIOLEX when used in combination, and assess any potential anti-inflammatory activity of TRIOLEX.

“The commencement of this clinical trial cap six years of international collaborations with world renowned experts working on the development of a new treatment for RA,” commented Dr. Dominick L. Auci, Director of Allergy, Autoimmunity and Inflammation at Hollis-Eden Pharmaceuticals.

“This body of work, presented over the years at numerous international meetings and published in peer reviewed journals, clearly documents the remarkable activity of TRIOLEX across several animal models of RA, each emphasizing different aspects of the pathophysiology thought to drive the human disease. We are particularly excited to begin this trial because TRIOLEX, without being immune suppressive, has consistently performed as well or better than the biologics in these models and works where methotrexate fails.”

Hollis-Eden has conducted extensive preclinical study with TRIOLEX in models of rheumatoid arthritis with striking results. The Company previously reported positive results from preclinical studies with TRIOLEX in models of collagen induced arthritis (CIA) and collagen antibody induced arthritis (CAIA). These models represent both the cell-mediated and antibody-mediated aspects of human rheumatoid arthritis.

In a model of CIA, mice were immunized to induce disease and were then treated orally with TRIOLEX or placebo beginning one week after disease onset. While the severity of arthritis worsened steadily in the placebo-treated group, it nearly resolved or remained at a minimum in the TRIOLEX-treated group.

Treatment resulted in a difference in arthritis severity that was on average 45% lower in the TRIOLEX-treated group than in the placebo-treated group. The DBA mouse model of CIA is a model widely used in industry and academia to test new agents as potential treatments for RA.