Trial Outcomes & Findings for A 6-Month Extension Study of VMDN-003-2 to Assess Engensis in Participants With Painful Diabetic Peripheral Neuropathy (NCT NCT04873232)

Last Updated: 2025-10-09

Results Overview

Change in the means of the Average Daily Pain Scores from the full Brief Pain Inventory for Diabetic Peripheral Neuropathy from the 7 days prior to the Day 0 Visit (Study VMDN-003-2) to the 7 days prior to the Day 365 Visit in the intent-to-treat population. The mean of the Average Daily Pain Scores are used for the primary endpoint recorded in the 7 days prior to the Days 270 and 365/ET Visits. The Brief Pain Inventory for Diabetic Peripheral Neuropathy scale is a 0 to 10 point scale with 10 being Pain as bad as you can imagine. The mean of at least 5 daily pain scores recorded for Question 5 of the Brief Pain Inventory for Diabetic Peripheral Neuropathy scale in electronic diary during the 7 days prior to the visits on Days 270 and 365/Early termination. The greater the negative difference between the followup visit and the Day 0 Baseline for each group for the average daily pain score in participants, would indicate that the average daily pain is declining.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

106 participants

Primary outcome timeframe

From the 7 days prior to the Day 0 Visit (Study VMDN-003-2, NCT04469270), Day 270, to the 7 days prior to the Day 365 Visit in the intent-to-treat population

Results posted on

2025-10-09

Participant Flow

Qualified subjects were anyone that completed the Day 180 visit in VMDN-003-2 (NCT04469270) and provided informed consent to be followed for another 6 months in this extension protocol VMDN-003-2b (NCT04873232). Subjects did not receive any further investigational prouct interventions.

Participant milestones

Participant milestones
Measure	Engensis Patients who have received Engensis in protocol VMDN-003-2 Engensis: Injections with Engensis in study VMDN-003-2	Placebo Patients who have received Placebo in protocol VMDN-003-2 Placebo: Injections with Placebo in study VMDN-003-2
Overall Study STARTED	49	57
Overall Study COMPLETED	47	53
Overall Study NOT COMPLETED	2	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Engensis Patients who have received Engensis in protocol VMDN-003-2 Engensis: Injections with Engensis in study VMDN-003-2	Placebo Patients who have received Placebo in protocol VMDN-003-2 Placebo: Injections with Placebo in study VMDN-003-2
Overall Study Lost to Follow-up	1	4
Overall Study Withdrawal by Subject	1	0

Baseline Characteristics

A 6-Month Extension Study of VMDN-003-2 to Assess Engensis in Participants With Painful Diabetic Peripheral Neuropathy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Engensis n=49 Participants Patients who have received Engensis in protocol VMDN-003-2 Engensis: Injections with Engensis in study VMDN-003-2	Placebo n=57 Participants Patients who have received Placebo in protocol VMDN-003-2 Placebo: Injections with Placebo in study VMDN-003-2	Total n=106 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	29 Participants n=93 Participants	34 Participants n=4 Participants	63 Participants n=27 Participants
Age, Categorical >=65 years	20 Participants n=93 Participants	23 Participants n=4 Participants	43 Participants n=27 Participants
Sex: Female, Male Female	18 Participants n=93 Participants	14 Participants n=4 Participants	32 Participants n=27 Participants
Sex: Female, Male Male	31 Participants n=93 Participants	43 Participants n=4 Participants	74 Participants n=27 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	7 Participants n=93 Participants	8 Participants n=4 Participants	15 Participants n=27 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	42 Participants n=93 Participants	49 Participants n=4 Participants	91 Participants n=27 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Asian	3 Participants n=93 Participants	3 Participants n=4 Participants	6 Participants n=27 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Black or African American	9 Participants n=93 Participants	17 Participants n=4 Participants	26 Participants n=27 Participants
Race (NIH/OMB) White	37 Participants n=93 Participants	36 Participants n=4 Participants	73 Participants n=27 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	1 Participants n=4 Participants	1 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants

PRIMARY outcome

Timeframe: From the 7 days prior to the Day 0 Visit (Study VMDN-003-2, NCT04469270), Day 270, to the 7 days prior to the Day 365 Visit in the intent-to-treat population

Population: Summary of Change from Baseline to Day 365 in ADPS (Intent-To-Treat Population)

Outcome measures

Outcome measures
Measure	Engensis n=49 Participants Patients who have received Engensis in protocol VMDN-003-2 Engensis: Injections with Engensis in study VMDN-003-2	Placebo n=57 Participants Patients who have received Placebo in protocol VMDN-003-2 Placebo: Injections with Placebo in study VMDN-003-2
To Evaluate the Efficacy of Intramuscular Administration of Engensis on Reducing Pain in Participants With Painful Diabetic Peripheral Neuropathy in the Feet and Lower Legs as Compared to Placebo Change from Baseline to 7 Days prior to the Day 365 visit	-2.53 score on a scale Standard Deviation 2.173	-2.78 score on a scale Standard Deviation 2.126
To Evaluate the Efficacy of Intramuscular Administration of Engensis on Reducing Pain in Participants With Painful Diabetic Peripheral Neuropathy in the Feet and Lower Legs as Compared to Placebo Change from Baseline to Day 270	-2.27 score on a scale Standard Deviation 2.083	-2.62 score on a scale Standard Deviation 2.087

SECONDARY outcome

Timeframe: From the 7 days prior to the Day 0 Visit (Study VMDN-003-2) to the 7 days prior to the Day 365 Visit for Engensis compared to Placebo

Population: Summary of Change from Day 0, Baseline, to Day 270, and Day 365 in Worst Pain Score (MI) (Intent-To-Treat Population)

Change in the means of the Worst Pain Scores from the full Brief Pain Inventory for Diabetic Peripheral Neuropathy from the 7 days prior to Day 0 Visit (Study VMDN-003-2), to Day 270, and 7 days prior to the Day 365 Visit for Engensis compared to Placebo. The Brief Pain Inventory for Diabetic Peripheral Neuropathy scale is a 0 to 10 point scale with 10 being Pain as bad as you can imagine. The mean of at least 5 worst daily pain scores recorded for Question 3 of the Brief Pain Inventory for Diabetic Peripheral Neuropathy in the electronic diary during the 7 days prior to the Visits on Days 270 and 365/Early termination. The greater the negative difference between the followup visit and the Day 0 Baseline for each group for the worst pain score in participants, would indicate that the worst pain is declining.

Outcome measures

Outcome measures
Measure	Engensis n=49 Participants Patients who have received Engensis in protocol VMDN-003-2 Engensis: Injections with Engensis in study VMDN-003-2	Placebo n=57 Participants Patients who have received Placebo in protocol VMDN-003-2 Placebo: Injections with Placebo in study VMDN-003-2
To Evaluate the Efficacy of IM Administration of Engensis on the Worst Pain in Participants With Painful Diabetic Peripheral Neuropathy in the Feet and Lower Legs as Compared to Placebo Change from Baseline to Day 270	-2.50 units on a scale Standard Deviation 2.376	-2.94 units on a scale Standard Deviation 2.664
To Evaluate the Efficacy of IM Administration of Engensis on the Worst Pain in Participants With Painful Diabetic Peripheral Neuropathy in the Feet and Lower Legs as Compared to Placebo Change from Baseline to Day 365	-2.65 units on a scale Standard Deviation 2.485	-3.19 units on a scale Standard Deviation 2.454

SECONDARY outcome

Timeframe: From Day 0 Visit (Study VMDN-003-2) to the Day 365 Visit

Population: Overall Summary of number of participants with Adverse Events (Safety Population)

Number of participants with adverse events and serious adverse events for Engensis compared to Placebo, including the number of participants with clinically significant laboratory values for Engensis compared to Placebo

Outcome measures

Outcome measures
Measure	Engensis n=49 Participants Patients who have received Engensis in protocol VMDN-003-2 Engensis: Injections with Engensis in study VMDN-003-2	Placebo n=57 Participants Patients who have received Placebo in protocol VMDN-003-2 Placebo: Injections with Placebo in study VMDN-003-2
To Evaluate the Safety of IM Administration of Engensis in the Number of Participants With Painful DPN in the Feet and Lower Legs as Compared to Placebo	16 Participants	22 Participants

SECONDARY outcome

Timeframe: From the 7 days prior to the Day 0 Visit (Study VMDN-003-2), to the 7 days prior to the Day 270 Visit, and 7 days prior to the Day 365 Visit

Population: Summary of Participant Responders with ≥50% reduction from Baseline Day 0 visit, in the Average Daily Pain Score to the 7 days prior to Day 270 and 7 days prior to the Day 365 visit (Intent-To-Treat Population)

Proportion of Responders (≥ 50% reduction in the Average Daily Pain Scores from the full Brief Pain Inventory for Diabetic Peripheral Neuropathy) from the 7 days prior to the Day 0 Visit (Study VMDN-003-2) to the 7 days prior to the Day 270 Visit and the 7 days prior to the Day 365 Visit for Engensis compared to Placebo.

Outcome measures

Outcome measures
Measure	Engensis n=49 Participants Patients who have received Engensis in protocol VMDN-003-2 Engensis: Injections with Engensis in study VMDN-003-2	Placebo n=57 Participants Patients who have received Placebo in protocol VMDN-003-2 Placebo: Injections with Placebo in study VMDN-003-2
To Evaluate the Efficacy of Administration of Engensis on Reducing Pain in Participants With Painful Diabetic Peripheral Neuropathy in the Feet and Lower Legs Responders with ≥50% reduction by Day 270	17 Participants	27 Participants
To Evaluate the Efficacy of Administration of Engensis on Reducing Pain in Participants With Painful Diabetic Peripheral Neuropathy in the Feet and Lower Legs Responders with ≥50% reduction by Day 365	16 Participants	27 Participants

Adverse Events

Engensis

Serious events: 3 serious events

Other events: 16 other events

Deaths: 0 deaths

Placebo

Serious events: 6 serious events

Other events: 22 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Engensis n=49 participants at risk Patients who have received Engensis in protocol VMDN-003-2 Engensis: Injections with Engensis in study VMDN-003-2	Placebo n=57 participants at risk Patients who have received Placebo in protocol VMDN-003-2 Placebo: Injections with Placebo in study VMDN-003-2
Cardiac disorders Acute coronary syndrome	0.00% 0/49 • Adverse events that started after the Day 180 Visit (Day 180 Visit date +1 day), and recorded up to the end of the study visit, Day 365. For each category, participants were included only once, even if they experienced multiple events in that category. Treatment-emergence was defined as adverse events that occurred the day after Day 180 Visit (Day 180 Visit date +1 day), and recorded by the end of the study visit, Day 365. Two participants signed informed consent but never returned for follow-up visits so Adverse Event information for them could not be collected.	1.8% 1/57 • Number of events 1 • Adverse events that started after the Day 180 Visit (Day 180 Visit date +1 day), and recorded up to the end of the study visit, Day 365. For each category, participants were included only once, even if they experienced multiple events in that category. Treatment-emergence was defined as adverse events that occurred the day after Day 180 Visit (Day 180 Visit date +1 day), and recorded by the end of the study visit, Day 365. Two participants signed informed consent but never returned for follow-up visits so Adverse Event information for them could not be collected.
Cardiac disorders Angina unstable	2.0% 1/49 • Number of events 1 • Adverse events that started after the Day 180 Visit (Day 180 Visit date +1 day), and recorded up to the end of the study visit, Day 365. For each category, participants were included only once, even if they experienced multiple events in that category. Treatment-emergence was defined as adverse events that occurred the day after Day 180 Visit (Day 180 Visit date +1 day), and recorded by the end of the study visit, Day 365. Two participants signed informed consent but never returned for follow-up visits so Adverse Event information for them could not be collected.	0.00% 0/57 • Adverse events that started after the Day 180 Visit (Day 180 Visit date +1 day), and recorded up to the end of the study visit, Day 365. For each category, participants were included only once, even if they experienced multiple events in that category. Treatment-emergence was defined as adverse events that occurred the day after Day 180 Visit (Day 180 Visit date +1 day), and recorded by the end of the study visit, Day 365. Two participants signed informed consent but never returned for follow-up visits so Adverse Event information for them could not be collected.
Cardiac disorders Atrial fibrillation	0.00% 0/49 • Adverse events that started after the Day 180 Visit (Day 180 Visit date +1 day), and recorded up to the end of the study visit, Day 365. For each category, participants were included only once, even if they experienced multiple events in that category. Treatment-emergence was defined as adverse events that occurred the day after Day 180 Visit (Day 180 Visit date +1 day), and recorded by the end of the study visit, Day 365. Two participants signed informed consent but never returned for follow-up visits so Adverse Event information for them could not be collected.	1.8% 1/57 • Number of events 1 • Adverse events that started after the Day 180 Visit (Day 180 Visit date +1 day), and recorded up to the end of the study visit, Day 365. For each category, participants were included only once, even if they experienced multiple events in that category. Treatment-emergence was defined as adverse events that occurred the day after Day 180 Visit (Day 180 Visit date +1 day), and recorded by the end of the study visit, Day 365. Two participants signed informed consent but never returned for follow-up visits so Adverse Event information for them could not be collected.
Cardiac disorders Atrioventricular block complete	0.00% 0/49 • Adverse events that started after the Day 180 Visit (Day 180 Visit date +1 day), and recorded up to the end of the study visit, Day 365. For each category, participants were included only once, even if they experienced multiple events in that category. Treatment-emergence was defined as adverse events that occurred the day after Day 180 Visit (Day 180 Visit date +1 day), and recorded by the end of the study visit, Day 365. Two participants signed informed consent but never returned for follow-up visits so Adverse Event information for them could not be collected.	1.8% 1/57 • Number of events 1 • Adverse events that started after the Day 180 Visit (Day 180 Visit date +1 day), and recorded up to the end of the study visit, Day 365. For each category, participants were included only once, even if they experienced multiple events in that category. Treatment-emergence was defined as adverse events that occurred the day after Day 180 Visit (Day 180 Visit date +1 day), and recorded by the end of the study visit, Day 365. Two participants signed informed consent but never returned for follow-up visits so Adverse Event information for them could not be collected.
Cardiac disorders Coronary artery stenosis	0.00% 0/49 • Adverse events that started after the Day 180 Visit (Day 180 Visit date +1 day), and recorded up to the end of the study visit, Day 365. For each category, participants were included only once, even if they experienced multiple events in that category. Treatment-emergence was defined as adverse events that occurred the day after Day 180 Visit (Day 180 Visit date +1 day), and recorded by the end of the study visit, Day 365. Two participants signed informed consent but never returned for follow-up visits so Adverse Event information for them could not be collected.	1.8% 1/57 • Number of events 1 • Adverse events that started after the Day 180 Visit (Day 180 Visit date +1 day), and recorded up to the end of the study visit, Day 365. For each category, participants were included only once, even if they experienced multiple events in that category. Treatment-emergence was defined as adverse events that occurred the day after Day 180 Visit (Day 180 Visit date +1 day), and recorded by the end of the study visit, Day 365. Two participants signed informed consent but never returned for follow-up visits so Adverse Event information for them could not be collected.
Infections and infestations Cellulitis	0.00% 0/49 • Adverse events that started after the Day 180 Visit (Day 180 Visit date +1 day), and recorded up to the end of the study visit, Day 365. For each category, participants were included only once, even if they experienced multiple events in that category. Treatment-emergence was defined as adverse events that occurred the day after Day 180 Visit (Day 180 Visit date +1 day), and recorded by the end of the study visit, Day 365. Two participants signed informed consent but never returned for follow-up visits so Adverse Event information for them could not be collected.	1.8% 1/57 • Number of events 1 • Adverse events that started after the Day 180 Visit (Day 180 Visit date +1 day), and recorded up to the end of the study visit, Day 365. For each category, participants were included only once, even if they experienced multiple events in that category. Treatment-emergence was defined as adverse events that occurred the day after Day 180 Visit (Day 180 Visit date +1 day), and recorded by the end of the study visit, Day 365. Two participants signed informed consent but never returned for follow-up visits so Adverse Event information for them could not be collected.
Infections and infestations Gastroenteritis viral	2.0% 1/49 • Number of events 1 • Adverse events that started after the Day 180 Visit (Day 180 Visit date +1 day), and recorded up to the end of the study visit, Day 365. For each category, participants were included only once, even if they experienced multiple events in that category. Treatment-emergence was defined as adverse events that occurred the day after Day 180 Visit (Day 180 Visit date +1 day), and recorded by the end of the study visit, Day 365. Two participants signed informed consent but never returned for follow-up visits so Adverse Event information for them could not be collected.	0.00% 0/57 • Adverse events that started after the Day 180 Visit (Day 180 Visit date +1 day), and recorded up to the end of the study visit, Day 365. For each category, participants were included only once, even if they experienced multiple events in that category. Treatment-emergence was defined as adverse events that occurred the day after Day 180 Visit (Day 180 Visit date +1 day), and recorded by the end of the study visit, Day 365. Two participants signed informed consent but never returned for follow-up visits so Adverse Event information for them could not be collected.
Infections and infestations Post procedural cellulitis	0.00% 0/49 • Adverse events that started after the Day 180 Visit (Day 180 Visit date +1 day), and recorded up to the end of the study visit, Day 365. For each category, participants were included only once, even if they experienced multiple events in that category. Treatment-emergence was defined as adverse events that occurred the day after Day 180 Visit (Day 180 Visit date +1 day), and recorded by the end of the study visit, Day 365. Two participants signed informed consent but never returned for follow-up visits so Adverse Event information for them could not be collected.	1.8% 1/57 • Number of events 1 • Adverse events that started after the Day 180 Visit (Day 180 Visit date +1 day), and recorded up to the end of the study visit, Day 365. For each category, participants were included only once, even if they experienced multiple events in that category. Treatment-emergence was defined as adverse events that occurred the day after Day 180 Visit (Day 180 Visit date +1 day), and recorded by the end of the study visit, Day 365. Two participants signed informed consent but never returned for follow-up visits so Adverse Event information for them could not be collected.
Metabolism and nutrition disorders Dehydration	2.0% 1/49 • Number of events 1 • Adverse events that started after the Day 180 Visit (Day 180 Visit date +1 day), and recorded up to the end of the study visit, Day 365. For each category, participants were included only once, even if they experienced multiple events in that category. Treatment-emergence was defined as adverse events that occurred the day after Day 180 Visit (Day 180 Visit date +1 day), and recorded by the end of the study visit, Day 365. Two participants signed informed consent but never returned for follow-up visits so Adverse Event information for them could not be collected.	0.00% 0/57 • Adverse events that started after the Day 180 Visit (Day 180 Visit date +1 day), and recorded up to the end of the study visit, Day 365. For each category, participants were included only once, even if they experienced multiple events in that category. Treatment-emergence was defined as adverse events that occurred the day after Day 180 Visit (Day 180 Visit date +1 day), and recorded by the end of the study visit, Day 365. Two participants signed informed consent but never returned for follow-up visits so Adverse Event information for them could not be collected.
Nervous system disorders Syncope	0.00% 0/49 • Adverse events that started after the Day 180 Visit (Day 180 Visit date +1 day), and recorded up to the end of the study visit, Day 365. For each category, participants were included only once, even if they experienced multiple events in that category. Treatment-emergence was defined as adverse events that occurred the day after Day 180 Visit (Day 180 Visit date +1 day), and recorded by the end of the study visit, Day 365. Two participants signed informed consent but never returned for follow-up visits so Adverse Event information for them could not be collected.	1.8% 1/57 • Number of events 1 • Adverse events that started after the Day 180 Visit (Day 180 Visit date +1 day), and recorded up to the end of the study visit, Day 365. For each category, participants were included only once, even if they experienced multiple events in that category. Treatment-emergence was defined as adverse events that occurred the day after Day 180 Visit (Day 180 Visit date +1 day), and recorded by the end of the study visit, Day 365. Two participants signed informed consent but never returned for follow-up visits so Adverse Event information for them could not be collected.
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/49 • Adverse events that started after the Day 180 Visit (Day 180 Visit date +1 day), and recorded up to the end of the study visit, Day 365. For each category, participants were included only once, even if they experienced multiple events in that category. Treatment-emergence was defined as adverse events that occurred the day after Day 180 Visit (Day 180 Visit date +1 day), and recorded by the end of the study visit, Day 365. Two participants signed informed consent but never returned for follow-up visits so Adverse Event information for them could not be collected.	1.8% 1/57 • Number of events 1 • Adverse events that started after the Day 180 Visit (Day 180 Visit date +1 day), and recorded up to the end of the study visit, Day 365. For each category, participants were included only once, even if they experienced multiple events in that category. Treatment-emergence was defined as adverse events that occurred the day after Day 180 Visit (Day 180 Visit date +1 day), and recorded by the end of the study visit, Day 365. Two participants signed informed consent but never returned for follow-up visits so Adverse Event information for them could not be collected.

Other adverse events

Additional Information

Jinsub Lee, PhD

Helixmith, Co., LTD

Phone: +82-10-8256-0439

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee There is NOT an agreement between the Principal Investigator and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Publication restrictions are in place

Restriction type: OTHER