PPC-06 is an extended-release formulation of a fumaric acid ester, which showed encouraging results in patients with moderate to severe plaque psoriasis. In the study, PPC-06 met both co-primary endpoints, PASI-75 and IGA scores of 0 or 1, with at least a 2-point reduction from baseline, following 24 weeks of oral treatment.

The new drug is an oral molecule with a novel mechanism of action with the potential to address the unmet medical needs of psoriasis patients. A phase 2b clinical study was conducted to assess the tolerability, safety, and efficacy of three doses of PPC-06 over 24 weeks. In a randomized, double-blind, placebo-controlled, dose-finding multicentre efficacy and safety study conducted at 76 sites in the US, patients demonstrated stable, moderate to severe plaque psoriasis for at least six months, with PASI score ≥12, IGA scores ≥3, and psoriasis lesions involving 10% or more of the patient’s body surface area at study baseline. The most common adverse events reported were lymphocytopenia, eosinophilia, and gastrointestinal disorders, such as diarrhea, nausea, abdominal pain, and vomiting.