Processa Pharmaceuticals Announces First Patient Enrolled in the PCS12852 Phase 2A Trial for the Treatment of Gastroparesis
05 Aprile 2022 - 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 an unmet medical need, announced today that it
has enrolled its first patient in the Phase 2A clinical trial of
PCS12852 in patients with moderate to severe gastroparesis.
Gastroparesis is a chronic gastric motility disorder in which the
stomach does not empty food as quickly as it should, resulting in
potentially serious forms of heartburn, nausea, vomiting, and
bloating for millions of patients in the U.S. As such gastroparesis
is recognized to be a serious unmet medical need condition for
which patients need alternative treatment options.
Currently, the only FDA approved pharmaceutical
treatment for gastroparesis is metoclopramide, a dopamine D2
receptor antagonist, which is approved only for diabetic
gastroparesis, not for other subsets of gastroparesis.
Additionally, it carries a black box warning, limiting use for this
chronic disorder to less than 12 weeks due to potentially serious
side effects.
PCS12852 is a novel, potent, and highly
selective 5-hydroxytryptamine-4 (5-HT4) receptor agonist. Although
5-HT4 receptor agonists have been effective for the treatment of
gastroparesis in the past, the nonselective binding to other 5HT
receptors has resulted in serious side effects and lack of use in
gastroparesis patients. PCS12852 differs from other 5HT4 agonists
because it has greater potency and is a more selective 5-HT4
agonist with a binding affinity to the 5-HT4 receptor being
200-fold times the affinity for other 5-HT receptors. Furthermore,
preclinical and clinical studies with PCS12852 have shown minimal
side effects at the effective dose.
“We are very pleased to announce that we have
randomized the first patient in our PCS12852 Phase 2A study for the
treatment of patients with gastroparesis, " said Dr. Sian Bigora,
Chief Development Officer at Processa, “In our previous Phase 2A
clinical study in constipation patients, the gastric emptying rate
significantly improved while on PCS12852 with no safety concerns.
We expect this study to show a similar effect on the gastric
emptying rate as well as provide us with valuable data on the
effect of PCS12852 on the symptoms associated with gastroparesis in
both diabetic and idiopathic gastroparesis patients. Information
from the study will then be used to further design our Phase 2B
study.”
The 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 approximately twenty-four (24) patients in up to eight
centers in the United States. (NCT05270460)
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. Although there have
been advances in understanding the mechanisms and pathophysiology
of gastroparesis, there are still significant gaps in knowledge,
inconsistencies across studies, and potential differences between
different etiological groups (e.g., diabetic versus idiopathic).
Gastroparesis is associated with significantly lower survival. In
addition to its effect on mortality, gastroparesis symptoms
negatively impact the quality of life and day-to-day functioning of
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
Grafico Azioni Processa Pharmaceuticals (NASDAQ:PCSA)
Storico
Da Giu 2024 a Lug 2024
Grafico Azioni Processa Pharmaceuticals (NASDAQ:PCSA)
Storico
Da Lug 2023 a Lug 2024