Policy & Regulation
Dr. Reddy's Laboratories Touts Positive Topline Results from Phase 2b Study of PPC-06 in Patients with Moderate to Severe Plaque Psoriasis
11 June 2019 - - Indian pharmaceutical company Dr. Reddy's Laboratories Ltd. (BSE: 500124) (NSE: DRREDDY) (NYSE: RDY) has received positive topline results from its Phase 2b study of PPC-06 (formerly referred to as XP23829) in patients with moderate to severe plaque psoriasis, the company said.
In the study, PPC-06 met both co-primary endpoints i.e. PASI-75 and IGA scores of 0 or 1 with at least a 2-point reduction from baseline, after 24 weeks of oral treatment.
The detailed safety and efficacy data from the study will be presented in future dermatology conferences.
PPC-06 is an extended release formulation of a fumaric acid ester, in-licensed from Xenoport, Inc. for further development to treat moderate to severe plaque psoriasis.
A Phase 2b clinical study was conducted to evaluate the tolerability, safety and efficacy of three doses of PPC-06 over 24 weeks.
This was a randomized, double blind, placebo-controlled, dose-finding multicenter efficacy and safety study conducted at 76 sites in the US Patients had stable, moderate to severe plaque psoriasis for at least 6 months, with PASI (Psoriasis Area and Severity Index) scores ≥12, IGA (5-point Investigator's Global Assessment) scores ≥3, and psoriasis lesions involving 10% or more of the patient's Body Surface Area at study baseline.
A total of 426 patients were randomized in a 1: 1: 1: 1 ratio into 4 treatment arms: 400 mg QD, 400 mg BID, 600 mg BID, and placebo.
The co-primary end points of the study were PASI-75 (i.e. proportion of treated subjects achieving a 75% reduction in their PASI score over baseline) and IGA score of 0 or1 at week 24.
At week 24 analysis, PASI-75 was achieved by 44.3%, 47.2% and 39.7% patients in PPC-06 600 mg BID, 400 mg BID and 400 mg QD treatment groups respectively, against 20% of patients in the placebo group (p