Dr. Reddy’s Laboratories has announced positive topline results from its Phase 2b study of PPC-06 in treating patients with moderate to severe plaque psoriasis.
PPC-06 (formerly referred to as XP23829) is an extended release formulation of a fumaric acid ester (FAE), in-licensed from Xenoport, Inc. for further development to treat moderate to severe plaque psoriasis.
“PPC-06 is an oral molecule with a novel mechanism of action that has the potential to address unmet medical needs of psoriasis patients.” said Anil Namboodiripad PhD., Senior Vice President and Head, Proprietary Products Business in a press release.
The Phase 2b clinical study was conducted to evaluate the tolerability, safety and efficacy of three doses of PPC-06 over 24 weeks.
The multicenter trial was conducted at 76 sites in the US. 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.
Patients had stable, moderate to severe plaque psoriasis for at least 6 months, with PASI scores ≥12, IGA scores ≥3, and psoriasis lesions involving 10% or more of the patient’s Body Surface Area (BSA) at study baseline.
The study reported that PPC-06 has met both co-primary endpoints i.e. PASI-75 (Psoriasis Area and Severity Index) and IGA scores (5-point Investigator’s Global Assessment) of 0 or 1 with at least a 2-point reduction from baseline, after 24 weeks of oral treatment.
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. Additionally, 44.4%, 41.4% and 35.7% of patients in the PPC-06 600 mg BID and 400 mg BID and 400 mg QD groups, respectively, achieved an IGA score of 0 or 1 at week 24 against 22% of patients in the placebo group.
“PPC-06 may become the first approved oral prodrug of Monomethyl Fumarate (MMF) for treatment of moderate to severe plaque psoriasis in the US. Further clinical development requirements will be discussed with the US FDA to support the approval of this product”, said Anil Namboodiripad.