POSITIVE Trial: Tildrakizumab Significantly Improves Quality of Life in Psoriatic Disease
New findings from the POSITIVE trial demonstrate that tildrakizumab (Ilumya/Ilumetri) not only delivers strong skin clearance but also leads to major gains in psychological wellbeing, life quality, treatment satisfaction, and reduced family burden for patients with psoriatic disease. Improvements in wellbeing and itch relief appeared as early as week 16, were sustained through one year, and were accompanied by high treatment satisfaction and a favorable safety profile-highlighting tildrakizumab’s holistic benefit in real-world care.
Tildrakizumab is an investigational IL-23p19 inhibitor currently being evaluated in patients with moderate-to-severe plaque psoriasis.
Under terms of the license agreement, Almirall will pay Sun Pharma an initial upfront payment of US $50 million. Phase-3 studies of tildrakizumab have recently been completed. Sun Pharma will be eligible to receive development and regulatory milestone payments and, additionally, sales milestone payments and royalties on net sales, the terms of which are confidential. Almirall will be able to lead European studies, and participate in larger Global clinical studies for psoriasis indication subject to the terms of the Sun Pharma – Merck agreements, as well as certain cost sharing agreements. Sun Pharma will continue to lead development of tildrakizumab for other indications, where Almirall will have right of first negotiation for certain indications in Europe.
"Sun Pharma is committed to growing our dermatology franchise, with tildrakizumab as our lead investigational compound. We continue to build our pipeline and capabilities in this important therapeutic area of significant unmet need. We are proud to be partnering with a regional leader in dermatology, like Almirall, to bring tildrakizumab to the European market," said Dilip Shanghvi, Managing Director, Sun Pharma. "This agreement with Almirall follows the recent announcement that tildrakizumab is the first IL-23p19 inhibitor to demonstrate positive results in Phase-3 clinical trials and is another step towards preparing for future regulatory milestones that will potentially enable us to bring a new treatment option to patients with moderate-to-severe plaque psoriasis."
"This agreement with Sun Pharma allows us to add a novel biologic for treatment of psoriasis to our extensive dermatology portfolio," said Jorge Gallardo, President of Almirall. "This is an exciting time for the treatment of psoriasis, a disease which can take both a physical and emotional toll on patients' lives. Emerging new investigational drugs, like tildrakizumab, are increasingly targeted and will potentially offer patients and physicians another alternative."
Additionally, the license agreement has a provision for possible co-promotion agreement at some point in the future, subject to certain conditions.
Tildrakizumab Phase-3 trial outcome
In May 2016, the two pivotal Phase-3 clinical trials of tildrakizumab met their primary endpoints for both evaluated doses with topline results shared via a separate press release. The co-primary efficacy endpoints were: the proportion of participants with psoriasis Area Sensitivity Index 75 (PASI 75) response at week 12 compared to placebo and the proportion of participants with a Physician's Global Assessment (PGA) score of clear or minimal with at least a 2 grade reduction from baseline at week 12 compared to placebo. The overall safety profile of tildrakizumab in both Phase-3 clinical trials was consistent with the safety data observed in previously reported studies. Additionally, the second study included an etanercept comparator arm, with a key secondary endpoint comparing tildrakizumab and etanercept on PASI 75 and PGA. Tildrakizumab 200mg was superior to etanercept on both PASI 75 and PGA endpoints at week 12, while the 100 mg dose showed superiority to etanercept on PASI 75 only.
The preparations for submission of a Biologics License Application to the U.S. Food and Drug Administration are proceeding. The detailed findings from the Phase-3 clinical trials will be presented at upcoming scientific meetings.
About Tildrakizumab
Tildrakizumab is an investigational humanized, anti-IL-23p19 monoclonal antibody designed to selectively block the cytokine IL-23. With this precise targeting, tildrakizumab has the potential to help control the pathogenic cells responsible for the inflammatory process of psoriasis with limited impact on the rest of the immune system.
About Psoriasis
Psoriasis is a chronic immune disease that appears on the skin. It affects an estimated 7.5 million people in the U.S. and approximately 125 million people worldwide. It is a non-contagious disorder that speeds the growth cycle of skin cells1 and results in thick scaly areas of skin. The most common form of psoriasis, called plaque psoriasis, appears as red, raised areas of skin covered with flaky white scales, which may be itchy and painful and can crack and bleed. Despite existing treatment options, many people with plaque psoriasis continue to struggle with the ongoing, persistent nature of this chronic disease that often has a debilitating impact not only on their bodies but their everyday lives.
