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PROCESSA PHARMACEUTICALS ANNOUNCES RESULTS FROM THE PHASE 2 STUDY IN NECROBIOSIS LIPOIDICA
HANOVER, MD, March 17, 2020 (GLOBE NEWSWIRE) -- Processa Pharmaceuticals, Inc. (OTCQB: PCSA), a clinical stage biopharmaceutical company developing products
About this update from Processa Pharmaceuticals, Inc.
[{"type":"text","content":"HANOVER, MD, March 17, 2020 (GLOBE NEWSWIRE) -- Processa Pharmaceuticals, Inc. (OTCQB: PCSA), a clinical stage biopharmaceutical company developing products to improve the survival and/or quality of life for patients who have a high unmet medical need condition, announced the completion of its Phase 2 Necrobiosis Lipoidica (NL) clinical trial for PCS-499 (PCS499-NL01), a deuterated analog of one of the major metabolites of pentoxifylline (Trental®).\n The Phase 2 trial was a multicenter, open-label prospective study designed to determine the safety and tolerability of PCS-499 in patients with NL. The last patient completed the study in February 2020. The fully enrolled trial included twelve NL patients: two patients with open ulcers and ten patients with the mild to moderate form of NL and no ulcerations. PCS-499 was found to be safe and well tolerated in these patients at doses of 1.8 grams/day with no serious adverse events reported. Adverse events assessed as possibly/probably related to PCS-499 were reported by seven patients and were reported as mild and occurred mostly in the first few weeks of treatment and quickly resolved. As expected, gastrointestinal adverse events were reported most often. The two patients presenting with more severe ulcerated NL had ulcers for more than two months prior to dosing. At baseline the reference ulcer in one of the two patients measured 3.5 cm2 and had completely closed by Month 2 of treatment. The second patient had a baseline reference ulcer of 1.2 cm2 which completely closed by Month 9. In addition, while in the trial one of these patients also developed small ulcers at other sites as a result of contact trauma to the site and these ulcers resolved within one month. The other ten patients presenting with mild to moderate NL and no ulceration had some improvement of the NL lesions but not as dramatic as the more serious ulcerated patients. “We are pleased to successfully complete this Phase 2 trial and are encouraged by the positive safety and efficacy results obtained from the trial. On PCS-499 all the ulcers on our two ulcerated patients were completely closed, something that we believe occurs naturally in less than 10% of the patients with ulcers. PCS-499 may offer a new treatment for this chronic disfiguring condition and we are meeting with the FDA later this month to define the Ph...