DUR‑928 is an investigational product and has not been approved by the FDA for marketing in the U.S. for any indication.
Psoriasis is a chronic, immune-mediated, inflammatory skin disorder. It causes dysregulation of the growth cycle of epidermal cells, resulting in characteristic patches of raised, reddened, scaly skin that may itch and become irritated and painful. There is no cure for psoriasis, but treatment can ease symptoms.
DURECT has conducted an exploratory Phase 1b trial of DUR‑928 in psoriasis in Australia (9 evaluable patients). The double-blinded, placebo-controlled trial used a micro-plaque assay to assess the effect of intralesional injections of DUR‑928. Based on this study’s encouraging results, DURECT has commenced a Phase 2a, randomized, double-blind, vehicle-controlled proof-of-concept trial, in which DUR‑928 is applied topically once-daily for 28 days to patients with mild to moderate plaque psoriasis.
The trial is being conducted at multiple clinical sites in the U.S. Twenty patients are planned to be enrolled to obtain approximately 15 evaluable patients. Patients will serve as their own controls, applying DUR‑928 to the plaque on one arm and vehicle control (placebo) to a similar plaque on the other arm. After the treatment period, patients will be followed for an additional four weeks. The primary efficacy endpoint will be the change from baseline in local psoriasis score in the DUR‑928-treated plaques compared with the vehicle-treated plaques. The first patient was dosed in March 2019, and DURECT expects to announce top-line data from this study in the second half of 2019.
Psoriasis Study Schematic
Psoriasis affects more than 8 million Americans. According to the International Federation of Psoriasis Associations (IFPA), nearly 3% of the world’s population, or about 125 million people, has some form of psoriasis. Approximately 80% of patients with psoriasis have localized disease, affecting 10% or less of body surface area. Topical agents remain the mainstay of treatment for localized psoriasis.
DURECT currently holds the worldwide development and commercialization rights to DUR‑928 and other molecules identified as part of the Epigenetic Regulator Program.