Trial Outcomes & Findings for Safety, PK and Efficacy of PCS12852 on Gastric Emptying Rate in Patients With Moderate to Severe Gastroparesis (NCT NCT05270460)

Last Updated: 2023-07-21

Results Overview

Change from baseline in gastric emptying rate was determined by the AUC by Gastric Emptying Breath Test (GEBT) at Day 28 after administration of PCS12852 or placebo.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

25 participants

Primary outcome timeframe

~28 days

Results posted on

2023-07-21

Participant Flow

Participant milestones

Participant milestones
Measure	PCS12852 0.1mg PCS12852 0.1mg tablet PCS12852: PCS12852 oral tablet administered once daily	PCS12852 0.5mg PCS12852 0.5mg tablet PCS12852: PCS12852 oral tablet administered once daily	Placebo Similar in appearance to active study drug Placebo: Placebo comparator oral tablet administered once daily
Overall Study STARTED	9	8	8
Overall Study COMPLETED	9	6	8
Overall Study NOT COMPLETED	0	2	0

Reasons for withdrawal

Reasons for withdrawal
Measure	PCS12852 0.1mg PCS12852 0.1mg tablet PCS12852: PCS12852 oral tablet administered once daily	PCS12852 0.5mg PCS12852 0.5mg tablet PCS12852: PCS12852 oral tablet administered once daily	Placebo Similar in appearance to active study drug Placebo: Placebo comparator oral tablet administered once daily
Overall Study Adverse Event	0	1	0
Overall Study Early Termination	0	1	0

Baseline Characteristics

Safety, PK and Efficacy of PCS12852 on Gastric Emptying Rate in Patients With Moderate to Severe Gastroparesis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	PCS12852 0.1mg n=9 Participants PCS12852 0.1mg tablet PCS12852: PCS12852 oral tablet administered once daily	PCS12852 0.5mg n=8 Participants PCS12852 0.5mg tablet PCS12852: PCS12852 oral tablet administered once daily	Placebo n=8 Participants Similar in appearance to active study drug Placebo: Placebo comparator oral tablet administered once daily	Total n=25 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	7 Participants n=5 Participants	7 Participants n=7 Participants	6 Participants n=5 Participants	20 Participants n=4 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	5 Participants n=4 Participants
Sex: Female, Male Female	7 Participants n=5 Participants	8 Participants n=7 Participants	7 Participants n=5 Participants	22 Participants n=4 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	3 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	5 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants	14 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	4 Participants n=5 Participants	5 Participants n=7 Participants	2 Participants n=5 Participants	11 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	4 Participants n=4 Participants
Race (NIH/OMB) White	7 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants	16 Participants n=4 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Region of Enrollment United States	9 participants n=5 Participants	8 participants n=7 Participants	8 participants n=5 Participants	25 participants n=4 Participants
Woman of Childbearing Potential	2 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	3 Participants n=4 Participants

PRIMARY outcome

Timeframe: ~28 days

Population: The change from baseline to Day 28 in AUC was analyzed using an analysis of covariance (ANCOVA) model with fixed effects for treatment group and gastroparesis type (idiopathic gastroparesis \[IG\] or diabetic gastroparesis \[DG\]) and the baseline value as a continuous covariate. Only patients with a baseline and Day 28 value were included in the analysis. The parameters listed are the best comparison of the breath test as opposed to individual timepoints.

Change from baseline in gastric emptying rate was determined by the AUC by Gastric Emptying Breath Test (GEBT) at Day 28 after administration of PCS12852 or placebo.

Outcome measures

Outcome measures
Measure	PCS12852 0.1mg n=9 Participants PCS12852 0.1mg tablet PCS12852: PCS12852 oral tablet administered once daily	PCS12852 0.5mg n=6 Participants PCS12852 0.5mg tablet PCS12852: PCS12852 oral tablet administered once daily	Placebo n=8 Participants Similar in appearance to active study drug Placebo: Placebo comparator oral tablet administered once daily
Change in Gastric Emptying Rate From Baseline as Determined by the Area Under the Curve (AUC) of the Gastric Emptying Rate	267.12 kPCD/minutes Standard Error 708.056	283.09 kPCD/minutes Standard Error 871.664	221.74 kPCD/minutes Standard Error 738.728

PRIMARY outcome

Timeframe: ~28 days

Population: The change from baseline to Day 28 using the t50 metric was analyzed using an analysis of covariance (ANCOVA) model with fixed effects for treatment group and gastroparesis type (idiopathic gastroparesis \[IG\] or diabetic gastroparesis \[DG\]) and the baseline value as a continuous covariate. Only patients with a baseline and Day 28 value were included in the analysis. The parameters listed are the best comparison of the breath test as opposed to individual timepoints.

Time for 50% gastric emptying (t50) metric assessed by the GEBT

Outcome measures

Outcome measures
Measure	PCS12852 0.1mg n=9 Participants PCS12852 0.1mg tablet PCS12852: PCS12852 oral tablet administered once daily	PCS12852 0.5mg n=6 Participants PCS12852 0.5mg tablet PCS12852: PCS12852 oral tablet administered once daily	Placebo n=8 Participants Similar in appearance to active study drug Placebo: Placebo comparator oral tablet administered once daily
Change in Gastric Emptying Rate From Baseline Using t50 Metric for Gastric Emptying Rate	-4.89 Minutes Standard Error 12.320	-26.64 Minutes Standard Error 14.971	-11.15 Minutes Standard Error 12.365

PRIMARY outcome

Timeframe: Day 1

Population: PK parameters were not calculated for patients with 2 or fewer detectable concentrations in their PK profile.

PK parameters were estimated from concentration-time data using noncompartmental methods, as data permitted.

Outcome measures

Outcome measures
Measure	PCS12852 0.1mg n=7 Participants PCS12852 0.1mg tablet PCS12852: PCS12852 oral tablet administered once daily	PCS12852 0.5mg n=7 Participants PCS12852 0.5mg tablet PCS12852: PCS12852 oral tablet administered once daily	Placebo Similar in appearance to active study drug Placebo: Placebo comparator oral tablet administered once daily
Concentrations of PCS12852 in Plasma - Cmax	0.12211 ng/mL Standard Deviation 0.039216	0.59986 ng/mL Standard Deviation 0.329187	—

PRIMARY outcome

Timeframe: Day 1

Population: PK parameters were not calculated for patients with 2 or fewer detectable concentrations in their PK profile.

PK parameters were estimated from concentration-time data using noncompartmental methods, as data permitted.

Outcome measures

Outcome measures
Measure	PCS12852 0.1mg n=7 Participants PCS12852 0.1mg tablet PCS12852: PCS12852 oral tablet administered once daily	PCS12852 0.5mg n=7 Participants PCS12852 0.5mg tablet PCS12852: PCS12852 oral tablet administered once daily	Placebo Similar in appearance to active study drug Placebo: Placebo comparator oral tablet administered once daily
Concentrations of PCS12852 in Plasma - AUC0-last	0.6331 h*ng/mL Standard Deviation 0.27524	3.0612 h*ng/mL Standard Deviation 1.58834	—

PRIMARY outcome

Timeframe: Day 28

Population: PK parameters were not calculated for patients with 2 or fewer detectable concentrations in their PK profile.

PK parameters were estimated from concentration-time data using noncompartmental methods, as data permitted.

Outcome measures

Outcome measures
Measure	PCS12852 0.1mg n=7 Participants PCS12852 0.1mg tablet PCS12852: PCS12852 oral tablet administered once daily	PCS12852 0.5mg n=5 Participants PCS12852 0.5mg tablet PCS12852: PCS12852 oral tablet administered once daily	Placebo Similar in appearance to active study drug Placebo: Placebo comparator oral tablet administered once daily
Concentrations of PCS12852 in Plasma - AUC0-last	1.0987 h*ng/mL Standard Deviation 1.23183	7.4218 h*ng/mL Standard Deviation 7.10856	—

PRIMARY outcome

Timeframe: Day 28

Population: PK parameters were not calculated for patients with 2 or fewer detectable concentrations in their PK profile.

PK parameters were estimated from concentration-time data using noncompartmental methods, as data permitted.

Outcome measures

Outcome measures
Measure	PCS12852 0.1mg n=7 Participants PCS12852 0.1mg tablet PCS12852: PCS12852 oral tablet administered once daily	PCS12852 0.5mg n=5 Participants PCS12852 0.5mg tablet PCS12852: PCS12852 oral tablet administered once daily	Placebo Similar in appearance to active study drug Placebo: Placebo comparator oral tablet administered once daily
Concentrations of PCS12852 in Plasma - Cmax	0.11984 ng/mL Standard Deviation 0.068770	0.48100 ng/mL Standard Deviation 0.255856	—

SECONDARY outcome

Timeframe: Day 7

Population: Scores were not able to be calculated for some patients in 0.5mg group due to 2 patients discontinuing.

Change from baseline in the American Neurogastroenterology and Motility Society Gastroparesis Cardinal Symptom Index Daily Diary (ANMS GCSI-DD). Scores range from 0-4 for the gastroparesis-related symptoms (nausea, early satiety, postprandial fullness, upper abdominal pain, and vomiting), with 4 meaning a worse outcome.

Outcome measures

Outcome measures
Measure	PCS12852 0.1mg n=8 Participants PCS12852 0.1mg tablet PCS12852: PCS12852 oral tablet administered once daily	PCS12852 0.5mg n=6 Participants PCS12852 0.5mg tablet PCS12852: PCS12852 oral tablet administered once daily	Placebo n=8 Participants Similar in appearance to active study drug Placebo: Placebo comparator oral tablet administered once daily
Change From Baseline in the ANMS GCSI-DD	-0.02 score on a scale Standard Error 0.141	-0.69 score on a scale Standard Error 0.171	-0.58 score on a scale Standard Error 0.138

SECONDARY outcome

Timeframe: Day 14

Population: Scores were not able to be calculated for some patients in the 0.5mg group due to 2 patients discontinuing.

Change from baseline in the American Neurogastroenterology and Motility Society Gastroparesis Cardinal Symptom Index Daily Diary. Scores range from 0-4 for the gastroparesis-related symptoms (nausea, early satiety, postprandial fullness, upper abdominal pain, and vomiting), with 4 meaning a worse outcome.

Outcome measures

Outcome measures
Measure	PCS12852 0.1mg n=8 Participants PCS12852 0.1mg tablet PCS12852: PCS12852 oral tablet administered once daily	PCS12852 0.5mg n=6 Participants PCS12852 0.5mg tablet PCS12852: PCS12852 oral tablet administered once daily	Placebo n=8 Participants Similar in appearance to active study drug Placebo: Placebo comparator oral tablet administered once daily
Change From Baseline in the ANMS GCSI-DD	-0.62 Units on a scale Standard Error 0.218	-1.06 Units on a scale Standard Error 0.267	-0.82 Units on a scale Standard Error 0.210

SECONDARY outcome

Timeframe: Day 21

Population: Scores were not able to be calculated for some patients in the 0.5mg group due to 2 patients discontinuing.

Outcome measures

Outcome measures
Measure	PCS12852 0.1mg n=8 Participants PCS12852 0.1mg tablet PCS12852: PCS12852 oral tablet administered once daily	PCS12852 0.5mg n=6 Participants PCS12852 0.5mg tablet PCS12852: PCS12852 oral tablet administered once daily	Placebo n=8 Participants Similar in appearance to active study drug Placebo: Placebo comparator oral tablet administered once daily
Change From Baseline in the ANMS GCSI-DD	-0.57 Units on a scale Standard Error 0.237	-1.12 Units on a scale Standard Error 0.290	-0.91 Units on a scale Standard Error 0.228

SECONDARY outcome

Timeframe: Day 28

Population: Scores were not able to be calculated for some patients in the 0.5mg group due to 2 patients discontinuing.

Outcome measures

Outcome measures
Measure	PCS12852 0.1mg n=8 Participants PCS12852 0.1mg tablet PCS12852: PCS12852 oral tablet administered once daily	PCS12852 0.5mg n=6 Participants PCS12852 0.5mg tablet PCS12852: PCS12852 oral tablet administered once daily	Placebo n=8 Participants Similar in appearance to active study drug Placebo: Placebo comparator oral tablet administered once daily
Change From Baseline in the ANMS GCSI-DD	-0.61 Units on a scale Standard Error 0.254	-1.48 Units on a scale Standard Error 0.311	-1.00 Units on a scale Standard Error 0.244

Adverse Events

PCS12852 0.1mg

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

PCS12852 0.5mg

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	PCS12852 0.1mg n=9 participants at risk PCS12852 0.1mg tablet PCS12852: PCS12852 oral tablet administered once daily	PCS12852 0.5mg n=8 participants at risk PCS12852 0.5mg tablet PCS12852: PCS12852 oral tablet administered once daily	Placebo n=8 participants at risk Similar in appearance to active study drug Placebo: Placebo comparator oral tablet administered once daily
Gastrointestinal disorders Diarrhoea	0.00% 0/9 • Adverse events were collected from the time the Informed Consent Form was signed to the last study visit on Day 35.	62.5% 5/8 • Number of events 5 • Adverse events were collected from the time the Informed Consent Form was signed to the last study visit on Day 35.	0.00% 0/8 • Adverse events were collected from the time the Informed Consent Form was signed to the last study visit on Day 35.
Gastrointestinal disorders Abdominal Pain	0.00% 0/9 • Adverse events were collected from the time the Informed Consent Form was signed to the last study visit on Day 35.	12.5% 1/8 • Number of events 1 • Adverse events were collected from the time the Informed Consent Form was signed to the last study visit on Day 35.	0.00% 0/8 • Adverse events were collected from the time the Informed Consent Form was signed to the last study visit on Day 35.
Gastrointestinal disorders Gastrooesophageal Reflux Disease	0.00% 0/9 • Adverse events were collected from the time the Informed Consent Form was signed to the last study visit on Day 35.	12.5% 1/8 • Number of events 1 • Adverse events were collected from the time the Informed Consent Form was signed to the last study visit on Day 35.	0.00% 0/8 • Adverse events were collected from the time the Informed Consent Form was signed to the last study visit on Day 35.
Gastrointestinal disorders Nausea	0.00% 0/9 • Adverse events were collected from the time the Informed Consent Form was signed to the last study visit on Day 35.	12.5% 1/8 • Number of events 1 • Adverse events were collected from the time the Informed Consent Form was signed to the last study visit on Day 35.	0.00% 0/8 • Adverse events were collected from the time the Informed Consent Form was signed to the last study visit on Day 35.
Nervous system disorders Dizziness	0.00% 0/9 • Adverse events were collected from the time the Informed Consent Form was signed to the last study visit on Day 35.	12.5% 1/8 • Number of events 1 • Adverse events were collected from the time the Informed Consent Form was signed to the last study visit on Day 35.	0.00% 0/8 • Adverse events were collected from the time the Informed Consent Form was signed to the last study visit on Day 35.
Nervous system disorders Headache	0.00% 0/9 • Adverse events were collected from the time the Informed Consent Form was signed to the last study visit on Day 35.	12.5% 1/8 • Number of events 1 • Adverse events were collected from the time the Informed Consent Form was signed to the last study visit on Day 35.	0.00% 0/8 • Adverse events were collected from the time the Informed Consent Form was signed to the last study visit on Day 35.

Additional Information

Dr. Sian Bigora

Processa Pharmaceuticals Inc.

Phone: 410-693-6844

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place