Phytomedics has published the results of a six month, phase 2b clinical trial with an extract of Tripterygium wilfordii Hook F (TwHF) in August 18, 2009 issue of the Annals of Internal Medicine. The study was aimed at developing TwHF as PMI-001, in patients with rheumatoid arthritis.
The results demonstrated TwHF to be clinically superior to sulfasalazine (SSZ) using the standard American College of Rheumatology (ACR) criteria, with a comparable safety profile.
The trial was a randomized, double-blind, active-controlled study and conducted at 11 sites in the US, under the auspices of the National Institutes of Health (NIH) National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS). Patients received the TwHF extract 180mg/day, divided TID or SSZ 2g once daily for 24 weeks. The primary endpoint of the study was a 20% improvement in disease activity by ACR criteria (ACR20).
Laurie Smaldone, president and CEO of Phytomedics, said: Despite recent therapeutic advances, there remains significant unmet medical need for novel alternative therapies for many patients with rheumatoid arthritis. Many of these patients, even after treatment with multiple oral and parenteral drugs, continue to experience uncontrolled pain, joint swelling, fatigue, and impaired physical function.We are very pleased with the outcome from this study. We look forward to meeting with FDA to discuss development plans for PMI-001.