Sun Pharma recently reported that two pivotal Phase 3 studies, assessing the safety and efficacy of the IL-23p19 inhibitor antibody tildrakizumab (MK-3222) in patients with moderate-to-severe plaque psoriasis, met their primary endpoints for the two doses examined.
In the Phase 3 trials (MK-3222-010 and MK-3222-011), patients with moderate-to-severe plaque psoriasis were randomly assigned to tildrakizumab or placebo. Psoriasis Area Severity Index (PASI) and Physician Global Assessment (PGA) scores of clear or minimal, with at least a reduction of 2 grade from baseline at week 12, were the primary endpoints in the studies.
The safety profile of tildrakizumab in both trials was consistent with the safety results reported in previous studies. In the second trial (MK-3222-011), etanercept was included in a comparator arm, with a secondary endpoint comparing tildrakizumab and etanercept on PASI 75 and PGA. Results showed that at week 12, tildrakizumab 200mg was superior to etanercept on both PASI 75 and PGA endpoints, whereas tildrakizumab 100 mg was superior to etanercept only on PASI 75.
“Tildrakizumab is the first IL-23p19 inhibitor to demonstrate positive results in Phase-3 clinical trials for the treatment of moderate-to-severe plaque psoriasis, further validating the importance of the role of IL-23 in psoriasis. We are encouraged by these results and the potential to provide a new treatment option to patients with moderate-to-severe plaque psoriasis, a disease that often takes both a physical and emotional toll on their lives,” Dilip Shanghvi, managing director of Sun Pharma, said in a press release. “We would like to thank the over 1,800 patients who participated as well as the investigators at more than 200 clinical sites.”
Tildrakizumab is a monoclonal antibody designed for the treatment of immunologically mediated inflammatory disorders. The drug is intended to block interleukin-23, a cytokine that plays an important role in managing the immune system and autoimmune disease.
“While there are existing treatment options for psoriasis, many patients continue to struggle with the debilitating impact this chronic disease can have on their bodies, their lives and their families,” said Kim Papp, MD, clinical trial investigator and president, Probity Medical Research, Inc. “Tildrakizumab works by selectively targeting IL-23, specifically the p19 component of the cytokine. Blocking this key cytokine helps control the pathogenic cells responsible for the inflammatory process of psoriasis. These new data are encouraging and support the potential of tildrakizumab as a new treatment option for patients.”
These Phase 3 data will be presented at upcoming medical meetings. Sun Pharma is currently preparing submission of a Biologics License Application to the U.S. Food and Drug Administration.
Plaque psoriasis is an autoimmune disease that causes raised, red, scaly patches to appear on the skin. It typically affects the outside of the elbows, knees or scalp, though it can appear on any location. Some people report that psoriasis is itchy, burns and stings. Psoriasis is associated with other serious health conditions, such as diabetes, heart disease, and depression.
About 7.5 million adults in the U.S. have psoriasis, and plaque psoriasis is its most common form. Approximately 1.5 million Americans suffer from moderate-to-severe plaque psoriasis.