Processa Pharmaceuticals Announces PCS12852 Successfully Improves the Clinical Symptoms Associated with Gastroparesis in Phase 2A Trial
14 Dicembre 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, today announced positive top-line results on
the clinical symptoms associated with gastroparesis from a 4-week
Phase 2A study of PCS12852, which is being developed for the
treatment of patients with gastroparesis. The trial was a
placebo-controlled, randomized, dose-response study designed to
evaluate the safety, efficacy, and pharmacokinetics of two dosage
regimens of PCS12852 vs placebo (clinicaltrials.gov identifier
NCT05270460). Processa previously announced an improvement in the
primary endpoint of the study, the gastric emptying rate, in
patients that received a 0.5 mg daily dose of PCS12852. The results
from this Phase 2A study also showed that clinically meaningful
improvements in gastroparesis symptoms occurred in more patients
(i.e., a greater percentage of patients) receiving the PCS12852 0.5
mg daily dose than the placebo daily dose.
The study included 25 patients with moderate to
severe gastroparesis that received a daily dose of PCS12852 (0.1 mg
or 0.5 mg) or a placebo. Three patients dropped out of the study.
Two patients were in the 0.5 mg group (one because of mild-moderate
AEs and one did not provide a reason) and one in the 0.1 mg group
(the reason was not provided by the patient). Gastroparesis
symptoms were assessed using the American Neurogastroenterology and
Motility Society Gastroparesis Cardinal Symptom Index Daily Diary
(ANMS GCSI-DD), which is a validated patient-reported outcome
instrument that captures the daily core symptoms of gastroparesis.
Publications have stated that a reduction from the baseline of
greater than 0.5 in the total ANMS GCSI-DD score is clinically
significant (Revicki 2012; Parkman 2018). The total GCSI score is
the total of 5 symptom subscores which include nausea, vomiting,
early satiety, postprandial fullness, and upper abdominal pain.
Although the study was not powered to show a
statistically significant difference from the placebo, 100% of the
patients receiving the 0.5 mg daily dose of PCS12852 and no rescue
medication from Day 22-28 had a clinically meaningful reduction in
the total ANMS GCSI-DD score (i.e., a reduction of greater than 0.5
from baseline) while only 57% of the placebo group had a clinically
meaningful reduction. In addition, the magnitude of the improvement
for the total ANNMS GCSI-DD score and for the subscores was greater
for the 0.5 mg PCS12852 group than the placebo group. The 0.1 mg
PCS12852 daily dose group showed little to no improvement in
gastroparesis symptoms.
“This Phase 2A gastroparesis study shows a trend
toward an increase in the gastric emptying rate and clinically
meaningful improvements in gastroparesis symptoms in patients
receiving a 0.5 mg daily dose of PCS12852,” said Dr. Sian Bigora,
Chief Development Officer at Processa. “The reduction in clinical
symptoms and the continued improvement in the total ANMS GCSI-DD
score and multiple individual symptom scores were better for the
PCS12852 0.5 mg daily dose group than placebo or the 0.1 mg group.
These findings suggest that a longer treatment than 28 days may
result in greater differences in the gastroparesis symptoms for the
0.5 mg PCS12852 daily dose group when compared to the placebo dose
group. These results, consistent with the previous pre-clinical and
clinical studies, give us confidence that dosing 0.5 mg of PCS12852
daily for at least 12 weeks should improve the clinical symptom
score more than a placebo treatment.”
PCS12852 was shown to be generally
well-tolerated, with most AEs occurring in the 0.5 mg dose group
and consisting of either a mild or moderate grade. There were no
clinically significant cardiovascular, unexpected, severe, or
serious adverse events reported during the study.
With these positive results from the Phase 2A
trial, Processa will be designing the Phase 2B trial and submitting
it to their IND. Depending on priorities, funding, and
licensing/partnering opportunities a Phase 2B trial could be
initiated in 2023.
About PCS12852
PCS12852 is a novel, more potent, and more
selective 5-hydroxytryptamine-4 (5-HT4) receptor agonist than other
5-HT4 agonists approved by FDA. Other 5-HT4 receptor agonists have
been successful in treating GI motility disorders but given their
affinity for other receptors, more off-target side effects such as
cardiovascular side effects have occurred. In contrast, PCS12852
has been shown in non-clinical studies to be more potent and more
selective than other 5-HT4 agonists resulting in fewer adverse
events at the therapeutic range of treatment in pre-clinical
studies and no reported serious adverse events in clinical studies.
Other currently approved options for the treatment of gastroparesis
have black box warnings and/or are limited due to adverse
events.
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 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 these
criteria for selection to further develop its pipeline programs to
achieve high-value milestones effectively and efficiently. Active
clinical pipeline programs include Next Generation Capecitabine
PCS6422 (metastatic colorectal cancer and breast cancer), PCS499
(ulcerative necrobiosis lipoidica) and PCS12852 (GI
motility/gastroparesis). 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 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 Floyd(301)
651-4256mfloyd@processapharma.com
Patrick Lin(925) 683-3218plin@processapharma.com
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