Trial Outcomes & Findings for Efficacy and Safety of NYX-2925 in Subjects With Neuropathic Pain Associated With Diabetic Peripheral Neuropathy (DPN) (NCT NCT04146896)

NCT ID: NCT04146896

Last Updated: 2023-04-28

Results Overview

Change from baseline in the weekly mean of the daily Numeric Rating Scale (NRS) score assessing average pain intensity related to DPN in the past 24 hours. In the NRS, a participant selects a whole number (0 to 10) that best indicates the intensity of his/her pain, where 0 represents no pain and 10 represents worst pain imaginable.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 228 participants
• Primary outcome timeframe: Week 12
• Results posted on: 2023-04-28

Participant Flow

Participant milestones

Measure	NYX-2925 NYX-2925 50 mg QD NYX-2925 50 mg: NYX-2925 administered orally	Placebo Placebo QD Placebo: Placebo administered orally
Overall Study STARTED	114	114
Overall Study COMPLETED	97	92
Overall Study NOT COMPLETED	17	22

Reasons for withdrawal

Measure	NYX-2925 NYX-2925 50 mg QD NYX-2925 50 mg: NYX-2925 administered orally	Placebo Placebo QD Placebo: Placebo administered orally
Overall Study Adverse Event	5	8
Overall Study Lack of Efficacy	3	2
Overall Study Lost to Follow-up	0	1
Overall Study Non-compliance	5	4
Overall Study Withdrawal by Subject	3	5
Overall Study Randomized in error	1	2

Baseline Characteristics

Efficacy and Safety of NYX-2925 in Subjects With Neuropathic Pain Associated With Diabetic Peripheral Neuropathy (DPN)

Baseline characteristics by cohort

Measure	NYX-2925 n=114 Participants NYX-2925 50 mg QD NYX-2925 50 mg: NYX-2925 administered orally	Placebo n=114 Participants Placebo QD Placebo: Placebo administered orally	Total n=228 Participants Total of all reporting groups
Age, Continuous	61.7 years STANDARD_DEVIATION 7.73 • n=5 Participants	60.0 years STANDARD_DEVIATION 8.63 • n=7 Participants	60.8 years STANDARD_DEVIATION 8.22 • n=5 Participants
Sex: Female, Male Female	49 Participants n=5 Participants	51 Participants n=7 Participants	100 Participants n=5 Participants
Sex: Female, Male Male	65 Participants n=5 Participants	63 Participants n=7 Participants	128 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	42 Participants n=5 Participants	47 Participants n=7 Participants	89 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	72 Participants n=5 Participants	67 Participants n=7 Participants	139 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	3 Participants n=5 Participants	4 Participants n=7 Participants	7 Participants n=5 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
Race (NIH/OMB) Black or African American	21 Participants n=5 Participants	27 Participants n=7 Participants	48 Participants n=5 Participants
Race (NIH/OMB) White	86 Participants n=5 Participants	80 Participants n=7 Participants	166 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Region of Enrollment United States	114 participants n=5 Participants	114 participants n=7 Participants	228 participants n=5 Participants
Duration of DPN at Baseline (Years)	8.593 years STANDARD_DEVIATION 4.3059 • n=5 Participants	8.701 years STANDARD_DEVIATION 4.1238 • n=7 Participants	8.647 years STANDARD_DEVIATION 4.2065 • n=5 Participants

PRIMARY outcome

Timeframe: Week 12

Population: Modified Intent to Treat Population includes all subjects who received at least one dose of study drug with at least one post-baseline assessment of the pain intensity NRS

Change from baseline in the weekly mean of the daily Numeric Rating Scale (NRS) score assessing average pain intensity related to DPN in the past 24 hours. In the NRS, a participant selects a whole number (0 to 10) that best indicates the intensity of his/her pain, where 0 represents no pain and 10 represents worst pain imaginable.

Outcome measures

Measure	NYX-2925 n=113 Participants NYX-2925 50 mg QD NYX-2925 50 mg: NYX-2925 administered orally	Placebo n=112 Participants Placebo QD Placebo: Placebo administered orally
Pain Intensity Numeric Rating Scale (NRS) Score	-2.01 units on a scale Standard Deviation 1.821	-2.27 units on a scale Standard Deviation 2.102

SECONDARY outcome

Timeframe: Week 12

Population: Population Description: Modified Intent to Treat Population includes all subjects who received at least one dose of study drug with at least one post-baseline assessment of the pain intensity NRS

Change from baseline in the weekly mean of the Daily Sleep Interference Scale (DSIS) scores. The DSIS asks participants to ''Select the number that best describes how much your pain has interfered with your sleep during the past 24 hours.'' Response options for the DSIS range from 0 (did not interfere with sleep) to 10 (completely interfered with sleep/unable to sleep due to pain).

Outcome measures

Measure	NYX-2925 n=113 Participants NYX-2925 50 mg QD NYX-2925 50 mg: NYX-2925 administered orally	Placebo n=112 Participants Placebo QD Placebo: Placebo administered orally
Daily Sleep Interference Scale (DSIS) Score	-2.11 units on a scale Standard Deviation 1.903	-2.39 units on a scale Standard Deviation 2.344

SECONDARY outcome

Timeframe: Week 12

Population: Population Description: Modified Intent to Treat Population includes all subjects who received at least one dose of study drug with at least one post-baseline assessment of the pain intensity NRS

Number of subjects 'much improved' or 'very much improved' on Patient Global Impression of Change (PGI-C)

Outcome measures

Measure	NYX-2925 n=113 Participants NYX-2925 50 mg QD NYX-2925 50 mg: NYX-2925 administered orally	Placebo n=112 Participants Placebo QD Placebo: Placebo administered orally
Patient Global Impression of Change (PGI-C)	38 Participants	40 Participants

SECONDARY outcome

Timeframe: Week 12

Population: Population Description: Modified Intent to Treat Population includes all subjects who received at least one dose of study drug with at least one post-baseline assessment of the pain intensity NRS

Number of subjects achieving ≥30% pain reduction from baseline in the weekly mean NRS average pain intensity related to DPN

Outcome measures

Measure	NYX-2925 n=113 Participants NYX-2925 50 mg QD NYX-2925 50 mg: NYX-2925 administered orally	Placebo n=112 Participants Placebo QD Placebo: Placebo administered orally
Number of Subjects Achieving ≥30% Pain Reduction	51 Participants	52 Participants

SECONDARY outcome

Timeframe: Week 12

Population: Population Description: Modified Intent to Treat Population includes all subjects who received at least one dose of study drug with at least one post-baseline assessment of the pain intensity NRS

Number of subjects achieving ≥50% reduction from baseline in the weekly mean NRS average pain intensity related to DPN

Outcome measures

Measure	NYX-2925 n=113 Participants NYX-2925 50 mg QD NYX-2925 50 mg: NYX-2925 administered orally	Placebo n=112 Participants Placebo QD Placebo: Placebo administered orally
Number of Subjects Achieving ≥50% Reduction	29 Participants	35 Participants

SECONDARY outcome

Timeframe: Week 12

Population: Population Description: Modified Intent to Treat Population includes all subjects who received at least one dose of study drug with at least one post-baseline assessment of the pain intensity NRS

Change from baseline in the Norfolk Quality of Life Questionnaire - Diabetic Neuropathy (QOL-DN) score. The QOL-DN is a 47 item subject reported questionnaire. Scores range from 0-126, and lower scores indicate improved quality of life.

Outcome measures

Measure	NYX-2925 n=113 Participants NYX-2925 50 mg QD NYX-2925 50 mg: NYX-2925 administered orally	Placebo n=112 Participants Placebo QD Placebo: Placebo administered orally
Norfolk Quality of Life Questionnaire - Diabetic Neuropathy (QOL-DN) Score	-15.3 units on a scale Standard Deviation 17.91	-16.7 units on a scale Standard Deviation 21.14

SECONDARY outcome

Timeframe: Week 12

Population: Population Description: Modified Intent to Treat Population includes all subjects who received at least one dose of study drug with at least one post-baseline assessment of the pain intensity NRS

Number of subjects using rescue medication

Outcome measures

Measure	NYX-2925 n=113 Participants NYX-2925 50 mg QD NYX-2925 50 mg: NYX-2925 administered orally	Placebo n=112 Participants Placebo QD Placebo: Placebo administered orally
Use of Rescue Medication	100 Participants	97 Participants

Adverse Events

NYX-2925

Serious events: 1 serious events

Other events: 15 other events

Deaths: 0 deaths

Placebo

Serious events: 6 serious events

Other events: 15 other events

Deaths: 2 deaths

Serious adverse events

Measure	NYX-2925 n=114 participants at risk NYX-2925 50 mg QD NYX-2925 50 mg: NYX-2925 administered orally	Placebo n=114 participants at risk Placebo QD Placebo: Placebo administered orally
Cardiac disorders Acute Coronary Syndrome	0.88% 1/114 • Number of events 1 • Treatment emergent adverse events are defined as the start of the event occurring on or after the date of first dispensed study drug (Day 1, Baseline Visit) and before or on the last dose (Week 12). The protocol required adverse events to be followed to resolution of the adverse event.	0.00% 0/114 • Treatment emergent adverse events are defined as the start of the event occurring on or after the date of first dispensed study drug (Day 1, Baseline Visit) and before or on the last dose (Week 12). The protocol required adverse events to be followed to resolution of the adverse event.
General disorders Non Cardiac Acute Chest Pain	0.88% 1/114 • Number of events 1 • Treatment emergent adverse events are defined as the start of the event occurring on or after the date of first dispensed study drug (Day 1, Baseline Visit) and before or on the last dose (Week 12). The protocol required adverse events to be followed to resolution of the adverse event.	0.00% 0/114 • Treatment emergent adverse events are defined as the start of the event occurring on or after the date of first dispensed study drug (Day 1, Baseline Visit) and before or on the last dose (Week 12). The protocol required adverse events to be followed to resolution of the adverse event.
Gastrointestinal disorders Gastrointestinal Bleeding	0.00% 0/114 • Treatment emergent adverse events are defined as the start of the event occurring on or after the date of first dispensed study drug (Day 1, Baseline Visit) and before or on the last dose (Week 12). The protocol required adverse events to be followed to resolution of the adverse event.	0.88% 1/114 • Number of events 1 • Treatment emergent adverse events are defined as the start of the event occurring on or after the date of first dispensed study drug (Day 1, Baseline Visit) and before or on the last dose (Week 12). The protocol required adverse events to be followed to resolution of the adverse event.
Cardiac disorders Unstable Angina	0.00% 0/114 • Treatment emergent adverse events are defined as the start of the event occurring on or after the date of first dispensed study drug (Day 1, Baseline Visit) and before or on the last dose (Week 12). The protocol required adverse events to be followed to resolution of the adverse event.	0.88% 1/114 • Number of events 1 • Treatment emergent adverse events are defined as the start of the event occurring on or after the date of first dispensed study drug (Day 1, Baseline Visit) and before or on the last dose (Week 12). The protocol required adverse events to be followed to resolution of the adverse event.
Renal and urinary disorders Chronic kidney disease exacerbation	0.00% 0/114 • Treatment emergent adverse events are defined as the start of the event occurring on or after the date of first dispensed study drug (Day 1, Baseline Visit) and before or on the last dose (Week 12). The protocol required adverse events to be followed to resolution of the adverse event.	0.88% 1/114 • Number of events 1 • Treatment emergent adverse events are defined as the start of the event occurring on or after the date of first dispensed study drug (Day 1, Baseline Visit) and before or on the last dose (Week 12). The protocol required adverse events to be followed to resolution of the adverse event.
Cardiac disorders Acute myocardial infarction	0.00% 0/114 • Treatment emergent adverse events are defined as the start of the event occurring on or after the date of first dispensed study drug (Day 1, Baseline Visit) and before or on the last dose (Week 12). The protocol required adverse events to be followed to resolution of the adverse event.	0.88% 1/114 • Number of events 1 • Treatment emergent adverse events are defined as the start of the event occurring on or after the date of first dispensed study drug (Day 1, Baseline Visit) and before or on the last dose (Week 12). The protocol required adverse events to be followed to resolution of the adverse event.
Infections and infestations COVID-19 pneumonia	0.00% 0/114 • Treatment emergent adverse events are defined as the start of the event occurring on or after the date of first dispensed study drug (Day 1, Baseline Visit) and before or on the last dose (Week 12). The protocol required adverse events to be followed to resolution of the adverse event.	0.88% 1/114 • Number of events 1 • Treatment emergent adverse events are defined as the start of the event occurring on or after the date of first dispensed study drug (Day 1, Baseline Visit) and before or on the last dose (Week 12). The protocol required adverse events to be followed to resolution of the adverse event.
Cardiac disorders Worsening of coronary artery disease	0.00% 0/114 • Treatment emergent adverse events are defined as the start of the event occurring on or after the date of first dispensed study drug (Day 1, Baseline Visit) and before or on the last dose (Week 12). The protocol required adverse events to be followed to resolution of the adverse event.	0.88% 1/114 • Number of events 1 • Treatment emergent adverse events are defined as the start of the event occurring on or after the date of first dispensed study drug (Day 1, Baseline Visit) and before or on the last dose (Week 12). The protocol required adverse events to be followed to resolution of the adverse event.

Other adverse events

Measure	NYX-2925 n=114 participants at risk NYX-2925 50 mg QD NYX-2925 50 mg: NYX-2925 administered orally	Placebo n=114 participants at risk Placebo QD Placebo: Placebo administered orally
Gastrointestinal disorders Diarrhea	4.4% 5/114 • Number of events 5 • Treatment emergent adverse events are defined as the start of the event occurring on or after the date of first dispensed study drug (Day 1, Baseline Visit) and before or on the last dose (Week 12). The protocol required adverse events to be followed to resolution of the adverse event.	6.1% 7/114 • Number of events 7 • Treatment emergent adverse events are defined as the start of the event occurring on or after the date of first dispensed study drug (Day 1, Baseline Visit) and before or on the last dose (Week 12). The protocol required adverse events to be followed to resolution of the adverse event.
Gastrointestinal disorders Nausea	2.6% 3/114 • Number of events 3 • Treatment emergent adverse events are defined as the start of the event occurring on or after the date of first dispensed study drug (Day 1, Baseline Visit) and before or on the last dose (Week 12). The protocol required adverse events to be followed to resolution of the adverse event.	1.8% 2/114 • Number of events 2 • Treatment emergent adverse events are defined as the start of the event occurring on or after the date of first dispensed study drug (Day 1, Baseline Visit) and before or on the last dose (Week 12). The protocol required adverse events to be followed to resolution of the adverse event.
Gastrointestinal disorders Vomiting	1.8% 2/114 • Number of events 2 • Treatment emergent adverse events are defined as the start of the event occurring on or after the date of first dispensed study drug (Day 1, Baseline Visit) and before or on the last dose (Week 12). The protocol required adverse events to be followed to resolution of the adverse event.	1.8% 2/114 • Number of events 2 • Treatment emergent adverse events are defined as the start of the event occurring on or after the date of first dispensed study drug (Day 1, Baseline Visit) and before or on the last dose (Week 12). The protocol required adverse events to be followed to resolution of the adverse event.
Nervous system disorders Headache	4.4% 5/114 • Number of events 5 • Treatment emergent adverse events are defined as the start of the event occurring on or after the date of first dispensed study drug (Day 1, Baseline Visit) and before or on the last dose (Week 12). The protocol required adverse events to be followed to resolution of the adverse event.	3.5% 4/114 • Number of events 5 • Treatment emergent adverse events are defined as the start of the event occurring on or after the date of first dispensed study drug (Day 1, Baseline Visit) and before or on the last dose (Week 12). The protocol required adverse events to be followed to resolution of the adverse event.

Additional Information

Aptinyx Clinical Development

Aptinyx

Phone: 847-871-0377

Email: clinicalstudies@aptinyx.com

Results disclosure agreements

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