Full Press Release Details
| FOR IMMEDIATE RELEASE | For More Information: | |
| Patrick Lin | ||
| plin@processapharma.com | ||
| 925-683-3218 |
PHARMACEUTICALS RECEIVES FDA CLEARANCE
OF IND TO BEGIN PHASE 2 CLINICAL DEVELOPMENT OF
PCS-499 IN NECROBIOSIS LIPOIDICA PATIENTS
MD - October 2, 2018 - Processa Pharmaceuticals, Inc. (OTC: PCSA), a clinical
stage biopharmaceutical company developing products to improve the survival and/or quality of life for patients who have high
unmet medical need conditions, announced today that the U.S. Food and Drug Administration (FDA) has granted Processa clearance
to proceed with a Phase 2 clinical trial of PCS-499 in patients with Necrobiosis Lipoidica (NL) under a recently submitted Investigational
New Drug (IND) application.
is a chronic, disfiguring condition affecting the skin and the tissue under the skin typically
on the lower extremities with no currently approved FDA treatments. NL presents more commonly in women than in men and
ulceration can occur in approximately 30% of NL patients. More severe complications can occur, such as deep tissue infections
and osteonecrosis threatening life of the limb. Approximately 74,000 - 185,000 people in
the United States and 200,000 - 500,000 people worldwide are affected by NL.
degeneration of tissue occurring at the NL lesion site is caused by a number of pathophysiological changes which has made it extremely
difficult to develop effective treatments for this condition. PCS-499
may provide a solution since PCS-499 and its metabolites affect a number of biological pathways, several of which contribute to
the pathophysiology associated with NL.
there are no approved treatments for this devastating condition, we are pleased that the FDA not only granted PCS-499 orphan designation
for NL but also agreed with our proposal to move immediately to Phase 2. We plan to work closely with the FDA to efficiently demonstrate
the efficacy and safety of the drug in this patient population," said Dr. David Young, CEO of Processa Pharmaceuticals.
"We hope that the IND clearance for the Phase 2 trial represents the first of many milestones for the PCS-499 NL program."
about our Phase 2 trial in NL patients can be found at www.clinicaltrials.gov within the next 5-7 days.
Processa Pharmaceuticals, Inc.
Pharmaceuticals, Inc. was founded in 2017 in Hanover, Maryland, with a mission to develop products that can improve the survival
and/or quality of life for patients who have a high unmet medical need. The Company acquired
the assets of Promet Therapeutics, LLC in October of 2017 and assembled a proven regulatory science development team, management
team, and Board of Directors. The Processa drug development team members have been involved with more than 30 drug approvals
by the FDA (including drug products targeted to orphan disease conditions) and 100 FDA meetings. PCS-499 represents the first
Processa drug that can potentially be used in a number of unmet medical need conditions. For more information, please visit http://www.processapharma.com
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 documents filed by Processa Pharmaceuticals with the SEC, specifically
the most recent reports on Forms 10-K and 10-Q, which identify important risk factors that could cause actual results to differ
from those contained in the forward-looking statements.