Almirall, S.A. (Spanish Stock Exchange ticker: ALM) and Sun Pharma (Reuters: SUN.BO, Bloomberg: SUNP IN, NSE: SUNPHARMA, BSE: 524715, Sun Pharmaceutical Industries Ltd and includes its subsidiaries or associate companies, through its wholly owned subsidiary), have announced late breaking data from two pivotal phase-3 clinical trials (reSURFACE 1 and 2) achieving de primary endpoint of Tildrakizumab, an investigational IL-23p19 inhibitor, in patients with moderate-to-severe plaque psoriasis. Results have been presented at the 25th EADV Congress in Vienna, Austria.
The Phase-3 data results through week 28 have been presented for the first time as part of the “Late Breaking News” Session at the premier European dermatology conference where the latest in research and developments in the field are presented each year. Tildrakizumab clinical trials included over 1,800 patients from more than 200 clinical trial sites worldwide.
In the trials, an average of 63 percent of patients achieved 75 percent of skin clearance (Psoriasis Area Sensitivity Index or PASI 75) by week 12 after only two injections, and 77 percent achieved 75 percent skin clearance after 28 weeks and three injections of the 100 mg dose of tildrakizumab (64 percent and 80 percent in reSURFACE1, 61 percent and 74 percent in reSURFACE2). Similarly, an average of 57 percent and 66 percent of patients had a Physician’s Global Assessment (PGA) score of “clear” or “minimal” with the 100 mg dose at weeks 12 and 28 respectively.
Those receiving the 200 mg dose also saw an average of 64 percent and 78 percent of patients achieving PASI 75 at weeks 12 and 28 respectively. Also, 59 percent and 69 percent of the patients had PGA score of “clear” or “minimal” at weeks 12 and 28 respectively.
The data further showed that a higher number of patients on tildrakizumab achieved PASI 90 and 100 compared to placebo and etanercept. An average of 37 percent and 36 percent of patients on tildrakizumab achieved PASI 90 at week 12 with the 100 mg dose and 200 mg dose respectively which increased to 54 percent and 59 percent at week 28. Correspondingly, an average of 13 percent on tildrakizumab achieved PASI 100 at week 12 regardless of dose with an increase to 24 percent for the 100 mg dose and 30 percent for the 200 mg dose at week 28.
The overall safety profile of tildrakizumab in both Phase-3 clinical trials was consistent with the safety data observed in previously reported studies. The incidences of severe infections, malignancies, and extended major cardiovascular events (MACE) were low and similar across treatment groups (1-3 percent).
Prof. Christopher EM Griffiths MD FRCP FMedSci Foundation Professor of Dermatology, NIHR Senior Investigator the University of Manchester, and investigator in the reSURFACE phase-3 trials, affirms: “The two key results of the pivotal phase-3 clinical trials (reSURFACE 1 and 2) are the validation of the high levels of skin clearance which are maintained and the possibility of remission. Furthermore, tildrakizumab is shown as a key therapeutic option since it is effective with few injections”.
“The most common clinical form of psoriasis is plaque psoriasis, which affects 80% of patients” says Prof. Lluis Puig, MD, PhD, Director, Dept. of Dermatology, Hospital de la Santa Creu i Sant Pau. Professor, Universitat Autònoma de Barcelona Medical School. Member, EADV Board of Directors. “Psoriasis is associated with a marked reduction in quality of life and determines a great physical and psychosocial burden on patients, who often suffer poor self-esteem, difficulties in social interactions, and significant psychological distress”.
Eduardo Sanchiz, Almirall’s Chief Executive Officer, comments: “These phase-3 tildrakizumab results represent an important step for Almirall towards achieving its primary goal: to cover the unmet needs of healthcare professionals and patients suffering from dermatological conditions. We are proud to introduce tildrakizumab in Europe, which has the potential to be a new treatment alternative for moderate-to-severe psoriasis, helping to alleviate the physical and emotional toll of this chronic disease on patients’ lives”.
Additional findings from the phase-3 clinical trials will be presented at upcoming scientific meetings and the preparations for regulatory submissions in both the U.S. and Europe are proceeding. In July 2016, Almirall had announced a strategic licensing agreement with Sun Pharma on the development and commercialization of tildrakizumab for psoriasis in Europe.
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 impacting their everyday lives.
About Tildrakizumab Phase-3 reSURFACE Trial Design
Tildrakizumab Phase-3 studies (reSURFACE 1 and 2) are randomized, placebo-controlled, multicenter studies designed to demonstrate efficacy of tildrakizumab in moderate-to-severe plaque psoriasis compared to placebo and comparative drug and to assess safety and tolerability. The co-primary efficacy endpoint of the two placebo controlled studies were the proportion of patients 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 reSURFACE 2 also included an etanercept comparator arm, with a key secondary endpoint comparing tildrakizumab and etanercept on PASI 75 and PGA. Other co-secondary endpoint of both placebo controlled studies included PASI 90 and PASI 100 responses at week 12 and PASI 75, 90 and 100 and PGA responses from baseline at Week 28. PGA measures lesion thickness, erythema and scaling across all of a patient’s psoriasis lesions in order to determine the disease activity on a six-point scale from “clear” to “severe.” A PASI score is a measure of psoriatic plaque redness, scaling and thickness and extent of the involvement in each region of the body. Treatment efficacy is often measured by reduction of PASI from baseline (i.e. 75 percent reduction is known PASI 75), a 90 percent reduction is known as PASI 90 and PASI 100 is total clearance of skin 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.
About Sun Pharma, Almirall S.A, Europe, Agreement
Sun Pharma (Reuters: SUN.BO, Bloomberg: SUNP IN, NSE: SUNPHARMA, BSE: 524715, Sun Pharmaceutical Industries Ltd and includes its subsidiaries or associate companies), and its wholly owned subsidiary and Almirall (Spanish Stock Exchange ticker: ALM) closed on July 2016 a licensing agreement on the development and commercialization of Tildrakizumab for psoriasis in Europe.
Under terms of the license agreement, Almirall is 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 be eligible to receive development and regulatory milestone payments and, additionally, sales milestone payments and royalties on net sales. 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. The agreement between Sun Pharma and Almirall remains subject to the exclusive license agreement between Sun Pharma and Merck.Editor's Details
Last updated on: 03/10/2016
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