Data from Tildrakizumab Clinical Development Program Presented at the 2017 American Academy of Dermatology Meeting
Posted by fidest press agency su mercoledì, 8 marzo 2017
Barcelona, Spain, March 7, 2017 – Almirall S.L (Spanish Stock Exchange ticker: ALM) and Sun Pharmaceutical Industries Ltd (Reuters: SUN.BO, Bloomberg: SUNP IN, NSE: SUNPHARMA, BSE: 524715, “Sun Pharma” and includes its subsidiaries or associate companies), today announced that several new analyses from Phase-I and the pivotal Phase-III clinical trials (reSURFACE 1 and 2) of Tildrakizumab, an investigational IL-23p19 inhibitor being evaluated for the treatment of moderate-to-severe plaque psoriasis, was presented at the 2017 Annual American Academy of Dermatology (AAD) in Orlando, Florida.
Over 1,800 patients across more than 200 clinical sites participated in the Tildrakizumab Phase-III pivotal trials (reSURFACE 1 and 2). Data were presented for the first time demonstrating results through 28 weeks of treatment at the European Academy of Dermatology and Venerology (EADV) Congress in October 2016. Regulatory filings for Tildrakizumab in the U.S. and Europe are proceeding as planned.
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 worldwide1. It is a non-contagious disorder that speeds the growth cycle of skin cells1 and results in thick scaly areas of skin2. 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 bleed2. Despite existing treatment options, many people with plaque psoriasis continue to struggle with the ongoing, persistent nature of this chronic disease.
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. Phase-III Tildrakizumab data provide further evidence for the role of the Sun Pharma is committed to expanding our dermatology portfolio to bring healthcare providers and patients around the world more treatment options and ongoing support for conditions with high unmet medical needs like Psoriasis. Sun Pharma, along with its subsidiaries, is ranked fourth in dermatology prescription volume within the U.S. per IMS and is fifth largest specialty generic pharmaceutical company globally. In addition to the investigational candidate Tildrakizumab, an investigational anti-IL- 23p19 monoclonal antibody, Sun Dermatology is comprised of several branded products indicated for the treatment of acne and actinic keratosis with a focus on other dermatologic conditions with unmet needs such as Psoriasis and atopic dermatitis.