According to a story from sectorpublishingintelligence.co.uk, the biopharmaceutical company Processa Pharmaceuticals, Inc. recently announced that the first patient had been dosed in the company’s Phase 2 clinical trial. This trial is testing an experimental treatment in development by the company called PCD-499 as a treatment for necrobiosis lipoidica. Processa is committed to the development of therapies that improve quality of life and survival for patients with currently unmet medical needs.
About Necrobiosis Lipoidica
Necrobiosis lipoidica is a skin condition which is characterized by the premature death of cells in living tissue. The condition often appears alongside diabetes and, more rarely, rheumatoid arthritis. The cause is not well understood as it can appear in patients who otherwise are managing their disease effectively. It affects less than one percent of the diabetic population, but women appear to be more likely than men to get necrobiosis lipoidica. The first symptom is often a bruised skin appearance, followed by hardened, raised lesions. These lesions are vulnerable to ulceration and can appear on the shins, hands, forearms, abdomen, and, more rarely, the genitalia, nipples, or surgical sites. Injuries to the affected areas should be avoided as they often don’t heal properly. Treatment may include ultraviolet light therapy, steroid cream or injections, and low doses of aspirin. There is no clear cure and these approaches are not effective for all patients. To learn more about necrobiosis lipoidica, click here.
Treating Necrobiosis Lipoidica
While the primary goal of this clinical trial is the evaluation of the safety profile and effectiveness of PCD-499 in patients with necrobiosis lipoidica, the data from this trial will also be used to inform the design of larger scale clinical trials as well.
Finding an effective treatment for this skin condition has been difficult. This is primarily because there may be several processes and changes happening at the same time in necrobiosis lipoidica which is only exasperated by the degeneration of the skin tissue. However, this experimental drug is also intended to affect multiple biological processes at once including several that are involved in the condition.
Top-line data for this trial is expected to be made available later in 2019.
