Endpoint met in phase III trials of MK 3222 (tildrakizumab) in plaque psoriasis- Sun Pharma

Sun Pharma has announced data from two pivotal Phase-III clinical trials (reSURFACE 1 and 2) achieving the primary endpoint with MK 3222 (tildrakizumab) in patients with moderate-to-severe plaque psoriasis. 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 reSURFACE 1, 61 percent and 74 percent in reSURFACE 2). 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. Data were presented at the 25th European Academy of Dermatology and Venereology Congress.