Sun Pharmaceutical Industries Ltd and its subsidiaries, has announced late-breaking data from two pivotal phase-3 clinical trials (reSURFACE 1 and 2) achieving the primary endpoint with tildrakizumab, an investigational IL-23p19 inhibitor, in patients with moderate-to-severe plaque psoriasis at the 25th European Academy of Dermatology and Venereology (EADV) Congress in Vienna, Austria. As indicated in a previous press release, top line results from these studies were announced on May 4, 2016.
The phase-3 data results through week 28 were 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 per cent of patients achieved 75 per cent of skin clearance (Psoriasis Area Sensitivity Index or PASI 75) by week 12 after only two injections, and 77 per cent achieved 75 per cent skin clearance after 28 weeks and three injections of the 100 mg dose of tildrakizumab (64 per cent and 80 per cent in reSURFACE1, 61 per cent and 74 per cent in reSURFACE2). Similarly, an average of 57 per cent and 66 per cent 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 per cent of patients achieving PASI 75 at weeks 12 and 28 respectively. Also, 59 per cent and 69 per cent 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 per cent and 36 per cent of patients on tildrakizumab achieved PASI 90 at week 12 with the 100 mg dose and 200 mg dose respectively which increased to 54 per cent and 59 per cent at week 28. Correspondingly, an average of 13 per cent on tildrakizumab achieved PASI 100 at week 12 regardless of dose with an increase to 24 per cent for the 100 mg dose and 30 per cent 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 per cent).
“For patients with psoriasis, their condition is always top of mind and they struggle on a daily basis with the often debilitating effects of this chronic condition. In our studies, we saw that the targeted effects of tildrakizumab significantly improved skin clearance offering a potential new treatment option for many patients with quarterly dosing,” said Dr Kristian Reich, Professor of Dermatology at the Georg-August-University Göttingen and inflammation specialist at the Dermatologikum Hamburg in Germany.
“We are excited about these phase-3 tildrakizumab results that further validate the central role of IL-23 as a key regulatory cytokine and treatment target in psoriasis. Tildrakizumab has the potential to be a new treatment that helps people living with moderate-to-severe psoriasis,” said Jesper Jensen, executive vice president, biologics and dermatology, Sun Pharma. “At Sun Dermatology, we care to make a difference and seek to match our products and solutions making them accessible and available to patients and health care providers with unmet needs.”
Additional findings from the phase-3 clinical trials will be presented at upcoming scientific meetings and the preparations for regulatory submissions in both the US and Europe are proceeding. In July 2016, Sun Pharma had announced a strategic licensing agreement with Almirall S.A (Spain) on the development and commercialization of tildrakizumab for psoriasis in Europe.