PCS12852 Improves Gastric Emptying in Gastroparesis Patients
08 Novembre 2022 - 2:30PM
Processa Pharmaceuticals, Inc. (Nasdaq: PCSA), a diversified
clinical-stage company developing products to improve survival
and/or the quality of life for patients who have an unmet medical
need condition, announces positive gastric emptying results from
its PCS12852 Phase 2A trial in patients with moderate to severe
gastroparesis. This Phase 2A trial was a 4-week placebo-controlled,
randomized, dose-response trial designed to evaluate the effect of
PCS12852 on gastric emptying, safety, pharmacokinetics, and
gastroparesis symptoms. Two dosage regimens of PCS12852 versus
placebo were evaluated in patients with moderate to severe
gastroparesis.
PCS12852 is a novel, potent, and highly
selective 5-hydroxytryptamine-4 (5-HT4) receptor agonist. While
there are other 5-HT4 receptor agonists used to treat
gastrointestinal (GI) motility disorders, these have less 5-HT4
selectivity and are associated with serious cardiovascular side
effects due to the binding to other receptors. Although 2-5 million
patients have moderate to severe chronic gastroparesis in the U.S.,
the only FDA-approved treatment options for gastroparesis have
black box warnings and can only be used for 12 weeks due to adverse
events.
In contrast, PCS12852 has been shown in normal
healthy volunteers and constipation patients to increase GI
function with no cardiovascular and no serious adverse effects.
Adverse events associated with this Phase 2A trial were mild to
moderate, occurring within the first few days after starting
treatment, and quickly resolved without any sequelae. There were no
clinically significant cardiovascular, unexpected, or serious
adverse events (SAEs) reported during the study.
Since the gastric emptying rate in gastroparesis
patients is known to be delayed, the gastric emptying rate in the
Phase 2A study was assessed using the Cairn Diagnostic 13C
Spirulina Gastric Emptying Breath Test (GEBT), which is an
FDA-approved diagnostic tool used for measuring the rate of
solid-phase gastric emptying and for identifying delayed gastric
emptying. The gastric emptying rate half time (t50), as measured by
the GEBT from baseline to Day 28, was calculated for each
patient.
GEBT results from this small Phase 2A
Proof-of-Concept study, which included a total of 14 patients in
the 0.5 mg (6 patients) and placebo (8 patients) groups,
demonstrated statistical improvement in gastric emptying in
patients receiving 0.5 mg of PCS12852 as compared to placebo
at a p < 0.10 level. The mean (±SD) t50 change from baseline was
decreased for 0.5 mg PCS12852 compared with placebo by -31.90 ±
50.53 min vs -9.36 ±42.43 min, respectively. Differences were not
observed between the placebo and the 0.1 mg dose.
“We are pleased that this first Phase 2A study
with PCS12852 was able to demonstrate a prokinetic effect and
improve gastric emptying in gastroparesis patients,” said Dr. Sian
Bigora, Chief Development Officer at Processa. “The data from this
study will inform the design of our planned Phase 2B study.
Gastroparesis continues to be a serious disease that has unmet
needs, and we are hopeful that PCS12852 will ultimately help
improve the quality of life of gastroparesis patients.”
About Gastroparesis
Gastroparesis is a disorder characterized by
delayed gastric emptying of solid food in the absence of 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 the millions of patients with 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 its
Regulatory Science Approach criteria when selecting drugs for
development in order to achieve high-value milestones effectively
and efficiently. Active clinical pipeline programs include: PCS6422
(metastatic colorectal cancer, breast cancer), PCS12852
(gastroparesis, functional constipation), and PCS499 (ulcerative
necrobiosis lipoidica). Members of the Processa development team
have been involved with more than 30 approvals for indications in
almost every division of the FDA (including drug products targeted
to orphan disease conditions) and more than 100 FDA meetings
throughout their careers. For more information, visit our 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
Floydmfloyd@processapharma.com(301) 651-4256
Patrick Lin(925)
683-3218plin@processapharma.com
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