The Phase 2/3 clinical trial testing Diacerein 1% ointment (CCP-020) in epidermolysis bullosa (EB) patients has begun. Castle Creek Pharmaceuticals announced
the first patient with EB has enrolled in the study.
CCP-020 is a small molecule inhibitor of caspase-1 (CASP1) and interleukin-1 (IL-1) beta, 2 molecules involved in the inflammatory process. It is hypothesized that by attenuating the inflammatory signaling pathway associated with EB, CCP-020 can strengthen epidermal tissue and support healing.
In an earlier Phase 2 clinical trial, EB patients showed an average reduction in blistering of 60% after 4 weeks of treatment with CCP-020 ointment.
Patients with EB suffer greatly as their skin cannot heal or grow properly. Often referred to the worst disease you have never heard of, EB is a group of congenital connective tissue diseases that manifests as blisters in the skin that can lead to widespread health problems including limited mobility, trauma to internal organs, and dehydration.
The Phase 2/3 study, referred to as the DELIVERS study, will include sites in the US, Europe, Israel and Australia. A total of 80 EB patients will be enrolled in the randomized, double-blind study that will compare the efficacy of diacerein 1% ointment (CCP-020) to a control ointment applied once-daily for 8 weeks in people living with EBS.
Participants will report outcomes including pruritus, pain, and mobility week-to-week via an electronic diary. Follow-up visits will continue for a maximum of 22 weeks.
Many are hopeful that the CCP-020 ointment will help these patients.
Amy Paller, MD, director of the Northwestern University Skin Disease Research Center and lead investigator on the DELIVERS study said, "The topical formulation of diacerein 1% that we are investigating is potentially disease-modifying, which would represent an important advance in treatment for patients."
Brett Kopelan, executive director of the nonprofit organization debra of America added, "There is no treatment or cure. Pain management, wound care, and protective bandaging are the only treatment options. Supportive care, often by multiple providers including physicians, nurses, nutritionists, and psychological counselors, is all these patients have available right now. We are excited that Castle Creek is addressing EBS, which is the most common type of epidermolysis bullosa but is often the most underserved in terms of research into a treatment. We look forward to working hand-in-hand to educate the population about this trial."
For more information about the CCP-020 clinical trial, visit ClinicalTrials.gov