Psoriasis is a common chronic inflammatory disease in which the exact cause is unknown and alternative treatment options are needed. It is an autoimmune disease affecting 125 million people worldwide that is not highlighted as frequently as other chronic diseases. The effects of chronic plaque psoriasis on patient's reduced health related quality of life are similar to those seen with arthritis, hypertension, heart disease, diabetes and depression.
New insights into the immunopathogenesis of psoriasis have opened the door for future therapies. Research into the cause of psoriasis may lead to new, less toxic and more efficacious therapeutic alternatives for patients. More than a dozen products with different mechanisms of action than currently available treatments are currently in Phase II or Phase III clinical trials with key data expected in the next 6-12 months.
For example, Celgene Corporation's (CELG) apremilast is expected to be the next systemic oral small molecule and first PDE4 inhibitor treatment for psoriasis that will be submitted to the FDA for approval in the second half of 2013. Based on available clinical data, apremilast given orally at 20 or 30mg twice daily, appears to be efficacious, safe, and tolerable for patients with moderate-to-severe plaque psoriasis.
Other late-stage product candidates are advancing, with Phase III clinical trial results for Pfizer Inc.'s (PFE) tofacitinib, a JAK inhibitor, and Novartis' (NVS) AIN457, an IL-17 inhibitor, also expected in 2013. These two compounds will be the first to announce Phase III trial data for the treatment of psoriasis in their respective classes and, if positive, will offer new therapeutic options for patients.
In 2013, Eli Lilly (LLY) and Incyte (INCY) should report Phase IIb data for baricitinib, an orally administered selective JAK1 and JAK2 inhibitor that unlike Pfizer's tofacitinib is JAK3-sparing. The data from ongoing trials in psoriasis may demonstrate differences in the safety and efficacy of the different JAK inhibitors.
In the near-term, results from several randomized mid-stage trials are expected before the end of 2012. For example, data from Idera Pharmaceuticals' (IDRA) Phase II trial with IMO-3100, which has completed enrollment, and data from Actelion's (OTC:ALIOF) Phase II trial with ponesimod are both expected to be announced before the end of 2012.
Going forward, new insight into the cause of psoriasis, more effective treatments, and identification of novel drug targets could provide new hope for the treatment of one of the most prevalent autoimmune diseases. Accordingly, we produced a comprehensive white paper titled "Medical Advances May Help Improve Psoriasis Outcomes" to provide an overview of product candidates in clinical trials and the life science companies developing novel therapies for this disease.
To receive a free copy of the white paper, please click here.
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Additional disclosure: MD Becker Partners provides consulting services to Idera Pharmaceuticals (IDRA), which is mentioned in the article.