Processa Pharmaceuticals Announces First Patient Dosed in its Randomized Double-Blind, Placebo-Controlled Clinical Trial to Evaluate PCS499 in Treating Ulcerations in Patients Who Have Necrobiosis Lipoidica

Rhea-AI Summary

Processa Pharmaceuticals (NASDAQ: PCSA) has dosed its first patient in a Phase 2B trial for PCS499, targeting ulcerations in patients with Necrobiosis Lipoidica (NL), a rare skin disease affecting collagen. The trial aims to assess the efficacy of PCS499 compared to a placebo. Approximately 30% of NL patients experience open ulcers that impair quality of life. Sian Bigora, Chief Development Officer, expressed optimism about the trial's potential impact on treatment options for this underserved condition.

Positive

• First patient dosed in Phase 2B trial for PCS499 targeting ulcerations in NL.
• Potential to significantly improve treatment options for patients with no current therapies.

Negative

• None.

~Processa’s trial is currently enrolling patients with ulcerated Necrobiosis Lipoidica. Detailed information on the trial can be located on clinicaltrials.gov NCT#: 04800562.~

HANOVER, MD., May 20, 2021 (GLOBE NEWSWIRE) -- Processa Pharmaceuticals, Inc. (NASDAQ: PCSA), (“Processa” or the “Company”), a clinical-stage biopharmaceutical company developing products to improve the survival and/or quality of life for patients who have unmet medical needs, today announced it has dosed its first patient in the Processa trial to evaluate PCS499 in treating ulcerations in patients who have Necrobiosis Lipoidica (NL). NL is a rare, chronic, idiopathic, granulomatous disease of collagen degeneration caused by a number of very diverse pathophysiological changes in a patient. In approximately 30% of NL patients, an open ulcer forms that can have a significant impact on a patient’s quality of life.

Sian Bigora, Pharm.D., Chief Development Officer said “The incidence of ulcer closure as assessed by skin examination in patients treated with PCS499 as compared to placebo will be a true indication of what PCS499 can do for patients who currently have no treatment options available for the disease. We are excited to have randomized the first patient in this Phase 2B trial.”

The Principal Investigator for the trial is Dr. Misha Rosenbach. The present site Principal Investigators are Dr. Misha Rosenbach, Dr. Adeel Ahmad, Dr. Afsaneh Alavi, Dr. Walter Nahm and Dr. Todd Schlesinger. The first patient was dosed by Dr. Schlesinger at the Clinical Research Center of the Carolinas.

About Processa Pharmaceuticals, Inc.

The mission of Processa is to develop products with existing clinical evidence of efficacy for patients with unmet or underserved medical conditions who need treatment options that improve survival and/or quality of life. The Company uses these criteria for selection to further develop its pipeline programs to achieve high-value milestones effectively and efficiently. Active clinical pipeline programs include: PCS6422 (metastatic colorectal cancer and breast cancer), PCS499 (ulcerative necrobiosis lipoidica) and PCS12852 (GI motility/gastroparesis). The members of the Processa development team have been involved with more than 30 drug approvals by the FDA (including drug products targeted to orphan disease conditions) and more than 100 FDA meetings throughout their careers. For more information, visit the company’s website at www.ProcessaPharma.com.

Forward-Looking Statements

This release contains forward-looking statements. The statements in this press release that are not purely historical are forward-looking statements which involve risks and uncertainties. Actual future performance outcomes and results may differ materially from those expressed in forward-looking statements. Please refer to the registration statement relating to the securities being sold in this offering, which identifies important risk factors which could cause actual results to differ from those contained in the forward-looking statements.

For More Information:
Michael Floyd
mfloyd@processapharma.com
301-651-4256

James Carbonara
Hayden IR
(646) 755-7412
james@haydenir.com

FAQ

What is the purpose of the PCS499 trial?

The trial evaluates the efficacy of PCS499 in treating ulcerations in patients with Necrobiosis Lipoidica.

When was the first patient dosed in the PCS499 trial?

The first patient was dosed on May 20, 2021.

What condition is PCS499 targeting?

PCS499 is targeting ulcerations associated with Necrobiosis Lipoidica.

What percentage of NL patients develop ulcers?

Approximately 30% of patients with Necrobiosis Lipoidica develop open ulcers.

What are the potential implications of the PCS499 trial results?

Positive results could improve treatment options for patients suffering from a currently untreatable condition.