Necrobiosis Lipoidica Clinical Trial Completes Enrollment Ahead of Schedule

According to a story from, the biopharmaceutical company Processa Pharmaceuticals, Inc., has recently announced that it has completed enrollment for its phase 2 clinical trial. This trial will be evaluating the tolerability and safety characteristics of the company’s experimental drug PCS-499, which is being developed as a treatment for the rare disease necrobiosis lipoidica. Processa is focused on the development of therapeutics that will improve quality of life or survival for patients with unmet medical needs.

About Necrobiosis Lipoidica (NL)

Necrobiosis lipoidica is a skin condition in which the skin’s cells become damaged and die prematurely, leading to the appearance of disfiguring lesions on the skin in various areas of the body. The cause of the rare condition is poorly understood; however diabetes appears to be a dominant risk factor, and most patients with necrobiosis lipoidica also have diabetes. At times, it can be triggered by a local injury or trauma. It is also associated with rheumatoid arthritis. The primary symptom are the previously mentioned skin lesions, which may ulcerate if damaged; they may appear on the skins, forearms, abdomen, hands, genitalia, nipples, and surgical sites. Skin lesions and ulcers often do not heal or heal very slowly. Treatments for necrobiosis lipoidica are limited in their effectiveness and may include aspirin, ultra violet light therapy, steroid creams, and better control of comorbidities like diabetes; these measures are not effective for all patients. To learn more about necrobiosis lipoidica, click here.

About The Trial and PCS-499

Top line data from the clinical trial should be made available by the end of the year. So far in the trial doses of PCS-499 as high as 1.8 grams per day appears to well tolerated by the trial participants, with no severe adverse effects reported from the treatment so far. PCS-499 is being developed with the capability to impact several different biological pathways including some that have been linked to the appearance of necrobiosis lipoidica.

With no currently approved treatments from the US Food and Drug Administration (FDA), the results from this trial will have substantial importance for patients affected by this disfiguring skin condition.

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