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Processa Pharmaceuticals Announces Second Quarter 2021 Results and Provides Corporate Update
Adds fourth clinical asset, RX-3117, and targets major milestones in the second half of 2021 HANOVER, Md., Aug. 12, 2021 (GLOBE NEWSWIRE) -- Processa
About this update from Processa Pharmaceuticals, Inc.
[{"type":"text","content":"Adds fourth clinical asset, RX-3117, and targets major milestones in the second half of 2021 HANOVER, Md., Aug. 12, 2021 (GLOBE NEWSWIRE) -- Processa Pharmaceuticals, Inc. (Nasdaq: PCSA), a clinical stage biopharmaceutical company developing drugs to improve the survival and/or quality of life for patients who have an unmet medical need condition, announces today financial results for the quarter ended June 30, 2021, and provides corporate update. Dr. David Young, CEO and chairman of Processa, commented, “During the second quarter we made significant progress advancing our clinical programs, in-licensed another clinical asset - RX-3117 – and will have four clinical programs with addressable markets of $500 million to $1.5 billion. Looking at upcoming milestones, we have begun to develop the biomarker assays for 3117 in pancreatic cancer patients with the expectation that the assay validation will be completed in the first half of 2022. We also anticipate filing an IND in September for PCS12852 with site initiation beginning before year end. Additionally, we expect interim data for PCS6422 in the fourth quarter of 2021 and interim data for PCS499 during the first half of 2022. Taken altogether, we see a consistent cadence of upcoming catalysts and tremendous amount of near-term value creation.” Recent Highlights and New Developments Dosed our first two patients in the PCS499 Phase 2B ulcerative Necrobiosis Lipoidica (NL) trial. NL is a rare, chronic, idiopathic, granulomatous disease that can significantly effect a patient’s quality of life and is caused by a number of diverse pathophysiological changes in a patient. There are no approved treatments for NL or ulcerative NL and no acceptable standard of care. Approximately 30% of NL patients have the ulcerative form of NL.Dosed our first patient in our Phase 1B trial evaluating the safety and PK of PCS6422 and capecitabine when administered to patients with advanced, refractory GI cancer. The combination of PCS6422 and capecitabine is expected to improve the benefit-risk profile of capecitabine by improving capecitabine safety and/or efficacy.Licensed in PCS3117 (formerly RX-3117), an oral, anticancer agent with an improved pharmacological profile relative to gemcitabine. PCS3117 has a family of patents extending into 2036 as well as U.S. Food and Drug Administration (FDA) Orphan ...