Processa Announces Sites Selected for Phase 2B Clinical Trial to Treat Patients with Ulcerated Necrobiosis Lipoidica
17 Marzo 2021 - 2:15PM
Processa Pharmaceuticals, Inc. (Nasdaq: PCSA) ("Processa" or the
"Company"), a clinical stage company developing drugs for patients
who have unmet medical conditions that require better treatment
options to improve a patient’s survival and/or quality of life,
today announces that it has selected 5 U.S. clinical sites to
enroll patients with ulcerative necrobiosis lipoidica for the
Company’s Phase 2B trial “A Randomized, Double-blind,
Placebo-Controlled Clinical Trial to Evaluate the Efficacy and
Safety of PCS499 in Treating Ulcerations in Patients who Have
Necrobiosis Lipoidica.” Two to three additional clinical sites will
be selected in the future including sites outside the U.S.
Dr. Misha Rosenbach, Department of Dermatology
at the University of Pennsylvania, is the Principal Investigator on
the study. A summary of the study and a listing of the sites
selected can be found at https://clinicaltrials.gov using the NCT
number of NCT04800562. The study is expected to begin recruiting
patients within the next 30-60 days.
Necrobiosis Lipoidica (NL) is a rare, painful
condition affecting the skin and tissue under the skin typically on
the lower extremities. Ulcerations occur in up to 35% of patients
with NL, many times following minor trauma. Ulcerations often prove
challenging to treat and may lead to more severe complications,
such as deep tissue infections and osteonecrosis that can threaten
the life of the limb and lead to amputation. The ulcers run a
refractory course and usually are resistant to treatment. The
ulcers in NL can be painful leading to impaired quality of life for
these patients. The pathogenesis of NL remains unclear and although
various drugs have been tried, none of them is consistently
effective. PCS499 and its metabolites affect a number of biological
pathways, several of which contribute to the pathophysiology
associated with ulcerative NL.
“We have selected 5 US sites to evaluate this
ground-breaking new treatment for ulcerative necrobiosis lipoidica
and we expect to add a few more sites in the next few months
including sites outside the U.S. Unfortunately for patients with
ulcerative necrobiosis lipoidica, open ulcers often take years to
naturally heal, if they heal at all, and treatments to close the
ulcers in these patients do not exist. Fortunately, our preliminary
clinical evaluation of PCS499 in the treatment of patients with
ulcerative necrobiosis lipoidica suggests that PCS499 may be
effective in closing these ulcers within months of starting
treatment," said Dr. Sian Bigora, Chief Development Officer at
Processa.
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
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