Trial Outcomes & Findings for A Clinical Trial of Epizon-701 (EPN-701) in Subjects With End-Stage Renal Disease (ESRD) (NCT NCT05285787)

NCT ID: NCT05285787

Last Updated: 2024-09-25

Results Overview

Number of Participants with: Treatment-emergent AEs Treatment-emergent AEs assessed as related to the study drug. Serious Adverse Events Deaths

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 18 participants
• Primary outcome timeframe: Through study completion; over 14 days treatment and one week follow up.
• Results posted on: 2024-09-25

Participant Flow

Participant milestones

Measure	EPN-701, 10mg Orally Daily Over 14 Days Single arm EPN-701 (Oral): MK-7 Over 14 days
Overall Study STARTED	18
Overall Study COMPLETED	17
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Measure	EPN-701, 10mg Orally Daily Over 14 Days Single arm EPN-701 (Oral): MK-7 Over 14 days
Overall Study Withdrawal by Subject	1

Baseline Characteristics

A Clinical Trial of Epizon-701 (EPN-701) in Subjects With End-Stage Renal Disease (ESRD)

Baseline characteristics by cohort

Measure	EPN-701, 10mg Orally Daily Over 14 Days n=18 Participants Single arm EPN-701 (Oral): MK-7 Over 14 days
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	16 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants
Age, Continuous	54.4 years STANDARD_DEVIATION 10.3 • n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	18 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	18 participants n=5 Participants
Undercarboxylated Matrix Gla Protein (MGP), (pmol/L).	1031.66 pmol/L STANDARD_DEVIATION 422.563 • n=5 Participants

PRIMARY outcome

Timeframe: Through study completion; over 14 days treatment and one week follow up.

Population: All patients who received at least one dose of EPN-701 was included in the safety evaluation.

Number of Participants with:

Treatment-emergent AEs Treatment-emergent AEs assessed as related to the study drug. Serious Adverse Events Deaths

Outcome measures

Measure	EPN-701 Treatment Arm n=18 Participants Participants who received study drug
Number of Participants With Adverse Events (AEs)	8 participants

SECONDARY outcome

Timeframe: Through study completion; over 14 days treatment and one week follow-up.

Population: Pharmacokinetic (PK) Population: All enrolled patients who received all 14 days of dosing of study drug.

• Maximum plasma concentration of EPN-701 (Cmax) [ng/mL].

Outcome measures

Measure	EPN-701 Treatment Arm n=15 Participants Participants who received study drug
Plasma Concentrations of EPN-701.	256 ng/mL Standard Error 138

SECONDARY outcome

Timeframe: Through study completion; over 14 days treatment and one week follow-up.

Population: All enrolled patients who received all 14 days of dosing of study drug.

Time to maximum plasma concentration of EPN-701 (Tmax) (h).

Outcome measures

Measure	EPN-701 Treatment Arm n=15 Participants Participants who received study drug
Time to Maximum Plasma Concentration of EPN-701.	5.83 hours Standard Error 1.66

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 1 to Day 15

Population: Patients who had evaluable biomarker levels at Day 1 and Day 15.

The percent change in circulating biomarker: Undercarboxylated MGP (pmol/L) levels from Day 1 (Baseline) to Day 15 was measured.

Outcome measures

Measure	EPN-701 Treatment Arm n=18 Participants Participants who received study drug
Change From Baseline to Day 15 in Circulating Biomarker: Undercarboxylated Matrix Gla Protein (MGP), (Pmol/L).	-50.72 percent change Standard Deviation 20.041

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 1 to Day 22

Population: Patients who had evaluable biomarker levels at Day 1 and Day 22.

The percent change in circulating biomarker: Undercarboxylated MGP (pmol/L) levels from Day 1 (Baseline) to Day 22 was measured.

Outcome measures

Measure	EPN-701 Treatment Arm n=17 Participants Participants who received study drug
Change From Baseline to Day 22 in Circulating Biomarker: Undercarboxylated Matrix Gla Protein (MGP), (Pmol/L).	-48.41 percent change Standard Deviation 19.994

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 22

Population: Patients who had evaluable biomarker levels at Day 1 and Day 22.

The mean value of circulating biomarker: Undercarboxylated MGP (pmol/L) levels on Day 22 was measured.

Outcome measures

Measure	EPN-701 Treatment Arm n=17 Participants Participants who received study drug
Mean Value of Circulating Biomarker: Undercarboxylated Matrix Gla Protein (MGP), (Pmol/L) at Day 22.	468.80 pmol/L Standard Deviation 143.733

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 15

Population: Patients who had evaluable biomarker levels at Day 1 and Day 15.

Mean value of circulating biomarker: Undercarboxylated MGP (pmol/L) levels on Day 15 was measured.

Outcome measures

Measure	EPN-701 Treatment Arm n=18 Participants Participants who received study drug
Mean Measure of Circulating Biomarker: Undercarboxylated Matrix Gla Protein (MGP), (Pmol/L).	439.32 pmol/L Standard Deviation 117.083

Adverse Events

Adverse Events (AEs)

Serious events: 2 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Measure	Adverse Events (AEs) n=18 participants at risk All patients who received at least one dose of study drug EPN-701 were included in the safety evaluation. (None of the Treatment Emergent Adverse Events were considered to be related to study drug.)
Hepatobiliary disorders cholelithiasis	5.6% 1/18 • 14 days of treatment and 7 days of follow up.
Product Issues Pseudoaneurysm of Arteriovenous graft	5.6% 1/18 • 14 days of treatment and 7 days of follow up.

Other adverse events

Measure	Adverse Events (AEs) n=18 participants at risk All patients who received at least one dose of study drug EPN-701 were included in the safety evaluation. (None of the Treatment Emergent Adverse Events were considered to be related to study drug.)
Gastrointestinal disorders Diarrhea	5.6% 1/18 • Number of events 1 • 14 days of treatment and 7 days of follow up.
General disorders Fatigue	5.6% 1/18 • Number of events 1 • 14 days of treatment and 7 days of follow up.
Metabolism and nutrition disorders Hyperglycaemia	5.6% 1/18 • Number of events 1 • 14 days of treatment and 7 days of follow up.
Blood and lymphatic system disorders Thrombocytopenia	5.6% 1/18 • Number of events 1 • 14 days of treatment and 7 days of follow up.
Hepatobiliary disorders Cholelithiasis	5.6% 1/18 • Number of events 1 • 14 days of treatment and 7 days of follow up.
Respiratory, thoracic and mediastinal disorders Upper respiratory tract infection	5.6% 1/18 • Number of events 1 • 14 days of treatment and 7 days of follow up.
Injury, poisoning and procedural complications Vascular graft complication	5.6% 1/18 • Number of events 1 • 14 days of treatment and 7 days of follow up.
Musculoskeletal and connective tissue disorders Pain in extremity	5.6% 1/18 • Number of events 1 • 14 days of treatment and 7 days of follow up.
Nervous system disorders Peroneal nerve palsy	5.6% 1/18 • Number of events 1 • 14 days of treatment and 7 days of follow up.
Reproductive system and breast disorders Priapism	5.6% 1/18 • Number of events 1 • 14 days of treatment and 7 days of follow up.
Vascular disorders Hypertension	5.6% 1/18 • Number of events 1 • 14 days of treatment and 7 days of follow up.
Gastrointestinal disorders Nausea	5.6% 1/18 • Number of events 1 • 14 days of treatment and 7 days of follow up.
Gastrointestinal disorders Vomiting	5.6% 1/18 • Number of events 1 • 14 days of treatment and 7 days of follow up.
General disorders Oedema peripheral	5.6% 1/18 • Number of events 1 • 14 days of treatment and 7 days of follow up.
General disorders Hyperkalaemia	5.6% 1/18 • Number of events 1 • 14 days of treatment and 7 days of follow up.

Additional Information

John Rudy

Epizon Pharma

Phone: 2127551000

Email: jrudey@epizonpharma.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place