Processa Pharmaceuticals Cleared by FDA to Proceed with Phase 2a Trial for the Treatment of Gastroparesis
12 Ottobre 2021 - 2:30PM
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, announced today that they
have been cleared by the U.S. Food and Drug Administration (FDA) to
proceed with a Phase 2a clinical trial of PCS12852 in patients with
moderate to severe gastroparesis, an unmet medical need condition
for which patients need alternative, safer treatment options.
The only FDA-approved drug to treat
gastroparesis is metoclopramide, a dopamine D2 receptor antagonist
that has serious side effects and can only be used as a short-term
treatment. PCS12852 is a novel, potent and highly selective
5-hydroxytryptamine 4 (5-HT4) receptor agonist. Other 5-HT receptor
agonists with less 5-HT4 selectivity have been shown to
successfully treat gastrointestinal (GI) motility disorders such as
chronic constipation, constipation-predominant irritable bowel
syndrome, functional dyspepsia, and gastroparesis. However, these
less selective 5-HT4 agonists, such as cisapride, have been either
removed from the market or not approved for gastroparesis. The side
effects associated with the off-target receptor binding (e.g.,
cardiovascular side effects) of these 5-HT4 agonists, especially
the binding on 5-HT receptors other than 5-HT4, has limited their
use in gastroparesis and other conditions. Given the off-target
receptor binding of PCS12852 is minimal, no cardiovascular side
effects have been associated with PCS12852 in non-clinical
toxicology studies at concentrations as high as 1,000 times the
maximum concentration observed in humans, making PCS12852 a
potentially safe treatment option for gastroparesis and other GI
motility disorders.
“This decision by the FDA is an important
milestone in the clinical development program for PCS12852," said
Dr. David Young, CEO and Chairman of Processa, "We have clinical
data demonstrating that PCS12852 improves the gastric emptying rate
in patients with functional constipation. Our IND will allow us to
demonstrate that PCS12852 also improves the gastric emptying in
gastroparesis patients, a market estimated to be as much as $1.6
Billion. We expect to ramp up our Phase 2a gastroparesis trial over
the next few months and have our first patient dosed in
Q1-2022.”
The Phase 2a study is entitled, “A Phase 2A,
Placebo-controlled, Randomized, Dose Response Study of the Safety,
Pharmacokinetics and Efficacy of PCS12852 on Gastric Emptying Rate
Assessed by 13C Spirulina Gastric Emptying Breath Test (GEBT) in
Patients with Moderate to Severe Gastroparesis” and will be
conducted in up to eight centers in the Unites States.
About Gastroparesis
Gastroparesis is a disorder characterized by
delayed gastric emptying of solid food in the absence of a
mechanical obstruction, particularly pyloric stenosis. This delay
may result in the cardinal symptoms of early satiety, postprandial
fullness, nausea, vomiting, belching, bloating, and pain.
Gastroparesis can be idiopathic, associated with diabetes mellitus,
can occur after a medical intervention (iatrogenic or
post-surgical), may be associated with neurological disorders, or
may occur after a bacterial or viral infection. Gastroparesis is a
disease that can significantly impact the quality of life for
patients. With the limitation on currently approved treatments for
gastroparesis there still is a need for new, effective treatments
for this disorder.
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 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
Floydmfloyd@processapharma.com301-651-4256
Jason Assad(678)
570-6791Jassad@processapharma.com
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