The trial compared PMI-001 as a stand-alone, disease-modifying, anti-rheumatic drug (DMARD) to sulfasalazine (active treatment control) in subjects with RA. This study was conducted at 11 sites in the U.S., with the National Institutes of Health's (NIH) National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) being the coordinating center. Peter Lipsky, M.D. (IND-holder) chief, Autoimmunity Branch, NIAMS, and Raphaela Goldbach-Mansky, M.D., staff clinician, NIAMS, were the principal investigators. One hundred and twenty-one (121) subjects received treatment. Of these, 60 were randomized to PMI-001 and 61 were randomized to Sulfasalazine.
The primary efficacy endpoint in this study was the proportion of PMI-001 subjects who achieved an ACR20 response at the end of the trial in comparison to the proportion of sulfasalazine-treated subjects. At the end of the trial, a significantly greater proportion (53.3%) of subjects in the PMI-001 treatment group achieved an ACR20 response than in the sulfasalazine group (21.3%). In addition, responder rates for the ACR50 (36.7% vs 3.3%), and ACR70 (26.7% vs 3.3%) were significantly higher for subjects treated with PMI-001. Also, each of the ACR component variables demonstrated a significant improvement at the final visit. All variables except for the swollen-joint count also demonstrated significant improvement at the Week 2 visit. HAQ disability score also showed significant improvement 2 weeks after treatment with PMI-001 was started. In the hand and foot x-rays, the post-treatment mean change in the sub-scores for erosions / joint space narrowing and the total score for subjects treated with PMI-001 all demonstrated a numerical decrease. These scores increased in subjects treated with sulfasalazine. Both treatment groups showed similar overall adverse events rates, which were mild in nature.
"We are extremely pleased with the results of PMI-001 in this third clinical study," said Bertold Fridlender, president and CEO of Phytomedics Inc. "The magnitude of clinical activity observed with PMI-001 as a stand-alone DMARD demonstrates the potential clinical utility of this new drug candidate and further validates Phytomedics' novel drug development approach."
"Additionally, the fact that with an oral drug candidate we are able to reach such impressive stand-alone efficacy results so rapidly, with a mild side effect profile and early evidence of disease modification activity, speaks to the significant potential of PMI-001, not only in RA, but across the entire autoimmune disease category," said Fridlender.
About PMI-001
PMI-001 is a novel, orally bioavailable, small-molecule-based, plant-derived, multi-component disease modifying agent currently being developed for rheumatoid arthritis. PMI-001 exerts its potent anti-inflammatory and immunosuppressant activities through unique and synergistic modes of action, which involves potent inhibition of several families of pro-inflammatory genes. Potential applications of this drug candidate beyond rheumatoid arthritis include a wide range of autoimmune disorders including psoriasis, lupus, inflammatory bowel disease (IBD), and multiple sclerosis (MS).
About Phytomedics Inc.
Phytomedics Inc. (http://www.phytomedics.com) uses a broad and innovative proprietary technology platform formulated by Professor Ilya Raskin to discover, develop and manufacture novel, multi-component and multi-functional botanical therapeutics. Through this proprietary technology platform, the company has produced a broad pipeline of lead product candidates, several of which are in clinical development. Founded by Professor Ilya Raskin, Ph.D., presently the company's Chief Scientific Officer, Phytomedics Inc. conducts most of its R&D at the Biotech Center of Rutgers University.
Source: Phytomedics Inc.
