The clinical-stage biotechnology company Idera Pharmaceuticals has announced the results of a Phase IIa trial that demonstrate positive results for IMO-3100, a drug in development for moderate-to-severe plaque psoriasis.
Nearly half (48%) of the 25 psoriasis patients treated with IMO-3100, a selective antagonist of Toll-like Receptors (TLRs) 7 and 9, demonstrated improvements in Psoriasis Area Severity Index (PASI) scores of 35% to 90%. The randomized, double blind, placebo-controlled trial utilized two dose levels of IMO-3100 administered for 4 weeks, with a 4-week follow-up period. Among evaluable patients, the median PASI scores at treatment initiation were 14.9, 16.1 and 12.5 in the 0.16 mg/kg, 0.32 mg/kg and placebo cohorts, respectively.
Change in epidermal thickness was the primary endpoint for this trial, according to news reports. Skin biopsies were collected at baseline and after completion of treatment to investigate changes in epidermal thickness and immune cell infiltrates. Patients receiving IMO-3100 had a median change in epidermal thickness of -6.4%, compared to a median change of +7.7% for placebo-treated patients.
“The clinical activity of IMO-3100 demonstrated in patients with moderate-to-severe plaque psoriasis is encouraging, especially given the short duration of treatment in this study that was designed for initial explorations of safety and efficacy,” explains Alexa Kimball, MD, MPH, Vice Chair of the Department of Dermatology at Massachusetts General Hospital in Boston, MA and an investigator in the trial.
Idera Pharmaceuticals announced that it believes the results of this trial provide clinical proof-of-concept for the mechanism of action of selective TLR inhibition in psoriasis patients and, potentially, patients with other autoimmune and inflammatory disorders.
“We believe this trial in patients with moderate-to-severe plaque psoriasis provides clinical proof-of-concept for this first-in-class TLR antagonist, which represents a novel approach to the treatment of autoimmune diseases,” explains Sudhir Agrawal, D. Phil., CEO of Idera. “We are very pleased to have observed clinical responses after only four weeks of treatment. The insights gained from this trial support expansion of our TLR antagonist program for the treatment of autoimmune diseases. In 2013, we plan to advance the clinical development of a selective TLR antagonist for the treatment of moderate-to-severe plaque psoriasis and also for the treatment of lupus.”
