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. Over 20 patients have been enrolled with the goal of obtaining approximately 15 evaluable patients. Each patient serves as their own control, 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 are followed for an additional four weeks. The primary efficacy endpoint is the change from baseline in local psoriasis score in the DUR 928-treated plaques compared with the vehicle-treated plaques. DURECT expects to announce top-line data from this study by the end of 2019.
Psoriasis Study Schematic
Psoriasis is an inflammatory skin disease and an immune-mediated condition that causes the body to make new skin cells in days rather than weeks. Psoriasis affects an estimated 7.5 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. Psoriasis causes itchiness and irritation and may be painful. There is no cure, but currently approved treatment can ease symptoms. Approximately 80% of patients with psoriasis have localized disease, which can be treated with topical therapies. As such, topical agents remain the mainstay of psoriasis treatment. Other inflammatory skin disorders, such as atopic dermatitis, which affects approximately 32 million Americans, represent significant unmet medical needs. Most currently available topical treatments, such as steroids, are typically employed as first-line therapy and either slow down excessive skin cell proliferation or reduce inflammation.
DURECT currently holds the worldwide development and commercialization rights to DUR‑928 and other molecules identified as part of the Epigenetic Regulator Program.