Processa Pharmaceuticals Announces Launch of Website (www.Necrobiosislipoidicastudy.com) to Increase Awareness of Ulcerative Necrobiosis Lipoidica and to Inform Patients of the ongoing Phase 2B Study of PCS499
04 August 2022 - 6:00AM
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 need conditions, announces today
that it has launched a new website Necrobiosislipoidicastudy.com.
The website is designed to increase awareness of ulcerative
Necrobiosis Lipoidica (“uNL”), an extremely rare condition, and to
inform patients about the ongoing Phase 2 study that is
investigating the use of PCS499 for the treatment of this rare
condition.
Necrobiosis Lipoidica (NL) is a chronic skin
condition with no currently approved U.S. Food and Drug
Administration (FDA) treatment. It is believed that NL affects
22,000 – 50,000 people in the United States and is more common in
individuals with diabetes and women, with an average age of onset
between 20 and 60 years. People with NL experience a persistent
skin condition that develops into ulcerated lesions in about
one-third of cases. Ulceration can cause severe complications, such
as life-threatening infections and necrosis.
Processa Pharmaceuticals is conducting a
randomized, double blind, placebo-controlled study that will
evaluate the efficacy and safety of PCS499 as compared to placebo
for the treatment of ulcerations of patients with Necrobiosis
Lipoidica (NCT#NCT04800562). This study is currently recruiting in
the United States and is expected to enroll a total of 20
patients.
Sian Bigora, Pharm.D., Chief Development
Officer, said, “For patients with NL, the tissue below the skin can
become necrotic forming open ulcers which can last from months to
years with complications such as infections, amputation, and
cancer. Currently there is no FDA approved treatment for uNL or NL,
no standard of care, and the treatments that are used are generally
inadequate. We are conducting the Phase 2b study to hopefully show
that PCS499 can be an option for these patients who currently have
little to no options available”
For more information on the clinical study of PCS499, please
visit Necrobiosislipoidicastudy.com
PCS499
PCS499, is a deuterated analog of a major
metabolite of pentoxifylline (PTX or Trental®). PCS499 and its
active metabolites have a diverse pharmacology profile and can act
on multiple targets that play vital roles in the treatment of
various conditions. Investigators postulate that PCS499 may provide
a novel treatment solution for NL thanks to its metabolites, which
affect many of the biological pathways that contribute to the
physiological processes associated with NL.
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 (gastroparesis). The members of the
Processa development team have been involved with more than thirty
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 that 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 which
could cause actual results to differ from those contained in the
forward-looking statements.
For More Information:
Michael Floyd301-651-4256mfloyd@processapharmaceuticals.com
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