Trial Outcomes & Findings for Efficacy, Safety and Tolerability of VS-01 in Adult Patients With Acute-on-Chronic Liver Failure and Ascites (UNVEIL-IT)® (NCT NCT05900050)

Last Updated: 2026-07-23

Results Overview

The CLIF-C ACLF score is derived from the CLIF-C organ failure (OF) score. The formula for the CLIF-C ACLF score is CLIF-ACLF = 10\*\[0.33\*CLIF-C OF + 0.04\*Age + 0.63\*Ln(white cell count) -2\]. The CLIF-C ACLF score ranges from 0-100, where a higher score indicated a greater mortality risk.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

15 participants

Primary outcome timeframe

Day 7

Results posted on

2026-07-23

Participant Flow

A total of 15 participants were enrolled into this trial in the United States, Germany and France between July 2023 and October 2025.

The total duration of the trial for each participant was up to 94 days. The screening period was up to 4 days, and participants were followed from Day 1 up to Day 90. The trial was discontinued prematurely at the Sponsor's decision.

Participant milestones

Participant milestones
Measure	Active Treatment Group: VS-01 on Top of Standard of Care (SOC) Participants received the VS-01 intraperitoneal (i.p.) infusion over a dwell time of 3 hours (+30 min) on Days 1 to 4, on top of SOC. SOC was administered after each treatment session with VS-01, if applicable.	Control Group: SOC Alone Participants received SOC which was defined as the standard medical management of patients with decompensated cirrhosis and acute-on-chronic liver failure (ACLF) as per respective international clinical guidelines.
Overall Study STARTED	9	6
Overall Study COMPLETED	3	2
Overall Study NOT COMPLETED	6	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Active Treatment Group: VS-01 on Top of Standard of Care (SOC) Participants received the VS-01 intraperitoneal (i.p.) infusion over a dwell time of 3 hours (+30 min) on Days 1 to 4, on top of SOC. SOC was administered after each treatment session with VS-01, if applicable.	Control Group: SOC Alone Participants received SOC which was defined as the standard medical management of patients with decompensated cirrhosis and acute-on-chronic liver failure (ACLF) as per respective international clinical guidelines.
Overall Study Death	4	2
Overall Study Liver Transplant	2	0
Overall Study Withdrawal of Consent	0	1
Overall Study Lost to Follow-up	0	1

Baseline Characteristics

Efficacy, Safety and Tolerability of VS-01 in Adult Patients With Acute-on-Chronic Liver Failure and Ascites (UNVEIL-IT)®

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Active Treatment Group: VS-01 on Top of SOC n=9 Participants Participants received the VS-01 i.p. infusion over a dwell time of 3 hours (+30 min) on Days 1 to 4, on top of SOC. SOC was administered after each treatment session with VS-01, if applicable.	Control Group: SOC Alone n=6 Participants Participants received SOC which was defined as the standard medical management of patients with decompensated cirrhosis and ACLF as per respective international clinical guidelines.	Total n=15 Participants Total of all reporting groups
Sex: Female, Male Male	9 Participants n=9 Participants	3 Participants n=27 Participants	12 Participants n=267 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=9 Participants	0 Participants n=27 Participants	0 Participants n=267 Participants
Age, Continuous	56.59 years STANDARD_DEVIATION 8.210 • n=9 Participants	51.18 years STANDARD_DEVIATION 11.295 • n=27 Participants	54.43 years STANDARD_DEVIATION 9.571 • n=267 Participants
Sex: Female, Male Female	0 Participants n=9 Participants	3 Participants n=27 Participants	3 Participants n=267 Participants
Race (NIH/OMB) Asian	0 Participants n=9 Participants	0 Participants n=27 Participants	0 Participants n=267 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=9 Participants	0 Participants n=27 Participants	0 Participants n=267 Participants
Race (NIH/OMB) Black or African American	1 Participants n=9 Participants	1 Participants n=27 Participants	2 Participants n=267 Participants
Race (NIH/OMB) White	6 Participants n=9 Participants	5 Participants n=27 Participants	11 Participants n=267 Participants
Race (NIH/OMB) More than one race	0 Participants n=9 Participants	0 Participants n=27 Participants	0 Participants n=267 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=9 Participants	0 Participants n=27 Participants	2 Participants n=267 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=9 Participants	0 Participants n=27 Participants	1 Participants n=267 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	6 Participants n=9 Participants	6 Participants n=27 Participants	12 Participants n=267 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=9 Participants	0 Participants n=27 Participants	2 Participants n=267 Participants

PRIMARY outcome

Timeframe: Day 7

Population: FAS: All randomized participants. Only participants with available data were included in this analysis.

Outcome measures

Outcome measures
Measure	Active Treatment Group: VS-01 on Top of SOC n=5 Participants Participants received the VS-01 i.p. infusion over a dwell time of 3 hours (+30 min) on Days 1 to 4, on top of SOC. SOC was administered after each treatment session with VS-01, if applicable.	Control Group: SOC Alone n=2 Participants Participants received SOC which was defined as the standard medical management of patients with decompensated cirrhosis and ACLF as per respective international clinical guidelines.
Chronic Liver Failure Consortium (CLIF-C) ACLF Score at Day 7	50.852 score on a scale Standard Deviation 15.5459	39.866 score on a scale Standard Deviation 6.3557

SECONDARY outcome

Timeframe: Day 1 to Day 90

Population: FAS: All randomized participants.

90-Day mortality was reported as the number of deaths from Day 1 to Day 90.

Outcome measures

Outcome measures
Measure	Active Treatment Group: VS-01 on Top of SOC n=9 Participants Participants received the VS-01 i.p. infusion over a dwell time of 3 hours (+30 min) on Days 1 to 4, on top of SOC. SOC was administered after each treatment session with VS-01, if applicable.	Control Group: SOC Alone n=6 Participants Participants received SOC which was defined as the standard medical management of patients with decompensated cirrhosis and ACLF as per respective international clinical guidelines.
Number of Deaths From Day 1 to Day 90	4 Participants	1 Participants

SECONDARY outcome

Timeframe: Day 1 to Day 28

Population: FAS: All randomized participants.

28-Day mortality was reported as the number of deaths from Day 1 to Day 28.

Outcome measures

Outcome measures
Measure	Active Treatment Group: VS-01 on Top of SOC n=9 Participants Participants received the VS-01 i.p. infusion over a dwell time of 3 hours (+30 min) on Days 1 to 4, on top of SOC. SOC was administered after each treatment session with VS-01, if applicable.	Control Group: SOC Alone n=6 Participants Participants received SOC which was defined as the standard medical management of patients with decompensated cirrhosis and ACLF as per respective international clinical guidelines.
Number of Deaths From Day 1 to Day 28	4 Participants	0 Participants

SECONDARY outcome

Timeframe: Day 1 to Day 90

Population: FAS: All randomized participants.

Time to death was calculated as death date - treatment start date. Participants who were not observed to have encountered the event through Day 90 were censored. The inter-quartile range was obtained via Kaplan Meier estimation.

Outcome measures

Outcome measures
Measure	Active Treatment Group: VS-01 on Top of SOC n=9 Participants Participants received the VS-01 i.p. infusion over a dwell time of 3 hours (+30 min) on Days 1 to 4, on top of SOC. SOC was administered after each treatment session with VS-01, if applicable.	Control Group: SOC Alone n=6 Participants Participants received SOC which was defined as the standard medical management of patients with decompensated cirrhosis and ACLF as per respective international clinical guidelines.
Time to Death Through Day 90	NA days Interval 18.0 to Values are not available due to the small number of participants analyzed that does not allow to run a Kaplan-Meier analysis and derive median and Q3.	NA days Values are not available due to the small number of participants analyzed that does not allow to run a Kaplan-Meier analysis and derive Q1, median and Q3.

SECONDARY outcome

Timeframe: Baseline to Day 7 and Day 28

Population: FAS: All randomized participants with ACLF at baseline and available data.

ACLF resolution was defined as ACLF grade 'No ACLF', for participants who had ACLF at Baseline.

Outcome measures

Outcome measures
Measure	Active Treatment Group: VS-01 on Top of SOC n=3 Participants Participants received the VS-01 i.p. infusion over a dwell time of 3 hours (+30 min) on Days 1 to 4, on top of SOC. SOC was administered after each treatment session with VS-01, if applicable.	Control Group: SOC Alone n=3 Participants Participants received SOC which was defined as the standard medical management of patients with decompensated cirrhosis and ACLF as per respective international clinical guidelines.
Number of Participants With ACLF Resolution Day 7 · Resolution	1 Participants	1 Participants
Number of Participants With ACLF Resolution Day 7 · No Resolution	2 Participants	2 Participants
Number of Participants With ACLF Resolution Day 28 · Resolution	1 Participants	2 Participants
Number of Participants With ACLF Resolution Day 28 · No Resolution	2 Participants	1 Participants

SECONDARY outcome

Timeframe: Baseline to Day 28

Population: FAS: All randomized participants. Only participants with available data were included in this analysis.

ACLF resolution was defined as ACLF grade 'No ACLF', for participants who had ACLF at Baseline. Time to ACLF resolution was calculated as (ACLF resolution date - treatment start date). Participants who were not observed to have encountered the event through Day 28 were censored at min\[trial discontinuation date; Day 28 visit date or treatment start date +27 if no visit date; last contact/assessment date for participant lost to follow-up; date of liver transplant or transjugular intrahepatic portosystemic shunt (TIPS)\]. The inter-quartile range was obtained via Kaplan Meier estimation.

Outcome measures

Outcome measures
Measure	Active Treatment Group: VS-01 on Top of SOC n=3 Participants Participants received the VS-01 i.p. infusion over a dwell time of 3 hours (+30 min) on Days 1 to 4, on top of SOC. SOC was administered after each treatment session with VS-01, if applicable.	Control Group: SOC Alone n=3 Participants Participants received SOC which was defined as the standard medical management of patients with decompensated cirrhosis and ACLF as per respective international clinical guidelines.
Time to ACLF Resolution Through Day 28	NA days Interval 3.0 to Values are not available due to the small number of participants analyzed that does not allow to run a Kaplan-Meier analysis and derive median and Q3.	13 days Interval 5.0 to Value is not available due to the small number of participants analyzed that does not allow to run a Kaplan-Meier analysis and derive Q3 value.

SECONDARY outcome

Timeframe: Baseline, Day 7 and Day 28

Population: FAS: All randomized participants.

ACLF regression was defined as regression of at least one full grade.

Outcome measures

Outcome measures
Measure	Active Treatment Group: VS-01 on Top of SOC n=9 Participants Participants received the VS-01 i.p. infusion over a dwell time of 3 hours (+30 min) on Days 1 to 4, on top of SOC. SOC was administered after each treatment session with VS-01, if applicable.	Control Group: SOC Alone n=6 Participants Participants received SOC which was defined as the standard medical management of patients with decompensated cirrhosis and ACLF as per respective international clinical guidelines.
Number of Participants With ≥ 1 ACLF Grade Regression Day 7 · Regression	1 Participants	1 Participants
Number of Participants With ≥ 1 ACLF Grade Regression Day 7 · No Regression	8 Participants	5 Participants
Number of Participants With ≥ 1 ACLF Grade Regression Day 28 · Regression	1 Participants	2 Participants
Number of Participants With ≥ 1 ACLF Grade Regression Day 28 · No Regression	8 Participants	4 Participants

SECONDARY outcome

Timeframe: Baseline and Day 28

Population: FAS: All randomized participants.

Time to ACLF ≥ 1 grade regression was calculated as (ACLF ≥ 1 grade regression date - treatment start date). Participants who were not observed to have encountered the event through Day 28 were censored. The inter-quartile range was obtained via Kaplan Meier estimation.

Outcome measures

Outcome measures
Measure	Active Treatment Group: VS-01 on Top of SOC n=9 Participants Participants received the VS-01 i.p. infusion over a dwell time of 3 hours (+30 min) on Days 1 to 4, on top of SOC. SOC was administered after each treatment session with VS-01, if applicable.	Control Group: SOC Alone n=6 Participants Participants received SOC which was defined as the standard medical management of patients with decompensated cirrhosis and ACLF as per respective international clinical guidelines.
Time to ≥ 1 ACLF Grade Regression Through Day 28	NA days Values are not available due to the small number of participants analyzed that does not allow to run a Kaplan-Meier analysis and derive Q1, median and Q3.	NA days Interval 13.0 to Values are not available due to the small number of participants analyzed that does not allow to run a Kaplan-Meier analysis and derive median and Q3.

SECONDARY outcome

Timeframe: Day 1 through Day 90

Population: FAS: All randomized participants.

Time to transplant was calculated as (transplant or death date - treatment start date). Participants who were not observed to have encountered the event through Day 90 were censored. The inter-quartile range was obtained via Kaplan Meier estimation.

Outcome measures

Outcome measures
Measure	Active Treatment Group: VS-01 on Top of SOC n=9 Participants Participants received the VS-01 i.p. infusion over a dwell time of 3 hours (+30 min) on Days 1 to 4, on top of SOC. SOC was administered after each treatment session with VS-01, if applicable.	Control Group: SOC Alone n=6 Participants Participants received SOC which was defined as the standard medical management of patients with decompensated cirrhosis and ACLF as per respective international clinical guidelines.
Secondary: Time to Transplant or Death Through Day 90 Death	22 days Interval 18.0 to Value is not available due to the small number of participants analyzed that does not allow to run a Kaplan-Meier analysis and derive Q3 value.	NA days Values are not available due to the small number of participants analyzed that does not allow to run a Kaplan-Meier analysis and derive Q1, median and Q3.

SECONDARY outcome

Timeframe: Up to Day 90

Population: Safety Analysis Set (SAS): All participants who received a dose of VS-01 on top of SOC, or SOC only (Control group).

An AE was defined as any untoward medical occurrence in a patient or clinical investigation participant administered a study drug and that does not necessarily have a causal relationship with this treatment. A TEAE was the appearance or worsening of any undesirable sign, symptom, or medical condition occurring after at least one dose of the study drug had been administered, even if the event was not considered to be related to the study drug. A serious AE (SAE) was any untoward medical event that occurs at any dose that: resulted in death; was life-threatening; required in-patient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; resulted in a congenital anomaly/birth defect; or was an important medical event.

Outcome measures

Outcome measures
Measure	Active Treatment Group: VS-01 on Top of SOC n=9 Participants Participants received the VS-01 i.p. infusion over a dwell time of 3 hours (+30 min) on Days 1 to 4, on top of SOC. SOC was administered after each treatment session with VS-01, if applicable.	Control Group: SOC Alone n=6 Participants Participants received SOC which was defined as the standard medical management of patients with decompensated cirrhosis and ACLF as per respective international clinical guidelines.
Number of Participants With Treatment-emergent Adverse Events (TEAEs) Any TEAEs	9 Participants	6 Participants
Number of Participants With Treatment-emergent Adverse Events (TEAEs) Any Grade 3 or Higher TEAEs	8 Participants	5 Participants
Number of Participants With Treatment-emergent Adverse Events (TEAEs) Any TEAEs Related to VS-01	6 Participants	NA Participants Participants in this group did not receive VS-01.
Number of Participants With Treatment-emergent Adverse Events (TEAEs) Any Serious TEAEs	7 Participants	5 Participants
Number of Participants With Treatment-emergent Adverse Events (TEAEs) Any Serious TEAEs Related to VS-01	2 Participants	NA Participants Participants in this group did not receive VS-01.

Adverse Events

Active Treatment Group: VS-01 on Top of SOC

Serious events: 7 serious events

Other events: 9 other events

Deaths: 4 deaths

Control Group: SOC Alone

Serious events: 5 serious events

Other events: 6 other events

Deaths: 2 deaths

Serious adverse events

Other adverse events

Additional Information

Pejvack Motlagh, M.D, M.Sc

Genfit SA

Phone: +3 33 20 16 40 00

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee All materials, information (oral or written) and unpublished documentation provided to the Investigators (or any company/institution acting on their behalf) are the exclusive property of the Sponsor and may not be given or disclosed, either in part or in whole, by the Investigator or by any person under his/her authority to any third party without the prior express consent of the Sponsor.
Publication restrictions are in place

Restriction type: OTHER

Measure	Active Treatment Group: VS-01 on Top of SOC n=9 participants at risk Participants received the VS-01 i.p. infusion over a dwell time of 3 hours (+30 min) on Days 1 to 4, on top of SOC. SOC was administered after each treatment session with VS-01, if applicable.	Control Group: SOC Alone n=6 participants at risk Participants received SOC which was defined as the standard medical management of patients with decompensated cirrhosis and ACLF as per respective international clinical guidelines.
Hepatobiliary disorders Chronic hepatic failure	11.1% 1/9 • Number of events 1 • Up to Day 90 SAS: All participants who received a dose of VS-01 on top of SOC, or SOC only (control group).	16.7% 1/6 • Number of events 1 • Up to Day 90 SAS: All participants who received a dose of VS-01 on top of SOC, or SOC only (control group).
Hepatobiliary disorders Hepatic cirrhosis	11.1% 1/9 • Number of events 1 • Up to Day 90 SAS: All participants who received a dose of VS-01 on top of SOC, or SOC only (control group).	16.7% 1/6 • Number of events 1 • Up to Day 90 SAS: All participants who received a dose of VS-01 on top of SOC, or SOC only (control group).
Hepatobiliary disorders Acute on chronic liver failure	11.1% 1/9 • Number of events 1 • Up to Day 90 SAS: All participants who received a dose of VS-01 on top of SOC, or SOC only (control group).	0.00% 0/6 • Up to Day 90 SAS: All participants who received a dose of VS-01 on top of SOC, or SOC only (control group).
Infections and infestations Infection	11.1% 1/9 • Number of events 1 • Up to Day 90 SAS: All participants who received a dose of VS-01 on top of SOC, or SOC only (control group).	0.00% 0/6 • Up to Day 90 SAS: All participants who received a dose of VS-01 on top of SOC, or SOC only (control group).
Infections and infestations Peritonitis	11.1% 1/9 • Number of events 1 • Up to Day 90 SAS: All participants who received a dose of VS-01 on top of SOC, or SOC only (control group).	0.00% 0/6 • Up to Day 90 SAS: All participants who received a dose of VS-01 on top of SOC, or SOC only (control group).
Infections and infestations Pneumonia	0.00% 0/9 • Up to Day 90 SAS: All participants who received a dose of VS-01 on top of SOC, or SOC only (control group).	16.7% 1/6 • Number of events 1 • Up to Day 90 SAS: All participants who received a dose of VS-01 on top of SOC, or SOC only (control group).
Infections and infestations Septic shock	11.1% 1/9 • Number of events 1 • Up to Day 90 SAS: All participants who received a dose of VS-01 on top of SOC, or SOC only (control group).	0.00% 0/6 • Up to Day 90 SAS: All participants who received a dose of VS-01 on top of SOC, or SOC only (control group).
Infections and infestations Spontaneous bacterial peritonitis	11.1% 1/9 • Number of events 2 • Up to Day 90 SAS: All participants who received a dose of VS-01 on top of SOC, or SOC only (control group).	0.00% 0/6 • Up to Day 90 SAS: All participants who received a dose of VS-01 on top of SOC, or SOC only (control group).
Nervous system disorders Hepatic encephalopathy	22.2% 2/9 • Number of events 2 • Up to Day 90 SAS: All participants who received a dose of VS-01 on top of SOC, or SOC only (control group).	0.00% 0/6 • Up to Day 90 SAS: All participants who received a dose of VS-01 on top of SOC, or SOC only (control group).
Nervous system disorders Disturbance in attention	0.00% 0/9 • Up to Day 90 SAS: All participants who received a dose of VS-01 on top of SOC, or SOC only (control group).	16.7% 1/6 • Number of events 1 • Up to Day 90 SAS: All participants who received a dose of VS-01 on top of SOC, or SOC only (control group).
Nervous system disorders Nervous system disorder	11.1% 1/9 • Number of events 1 • Up to Day 90 SAS: All participants who received a dose of VS-01 on top of SOC, or SOC only (control group).	0.00% 0/6 • Up to Day 90 SAS: All participants who received a dose of VS-01 on top of SOC, or SOC only (control group).
Gastrointestinal disorders Gastrointestinal haemorrhage	11.1% 1/9 • Number of events 1 • Up to Day 90 SAS: All participants who received a dose of VS-01 on top of SOC, or SOC only (control group).	16.7% 1/6 • Number of events 1 • Up to Day 90 SAS: All participants who received a dose of VS-01 on top of SOC, or SOC only (control group).
Renal and urinary disorders Acute kidney injury	11.1% 1/9 • Number of events 1 • Up to Day 90 SAS: All participants who received a dose of VS-01 on top of SOC, or SOC only (control group).	0.00% 0/6 • Up to Day 90 SAS: All participants who received a dose of VS-01 on top of SOC, or SOC only (control group).
Renal and urinary disorders Renal failure	11.1% 1/9 • Number of events 1 • Up to Day 90 SAS: All participants who received a dose of VS-01 on top of SOC, or SOC only (control group).	0.00% 0/6 • Up to Day 90 SAS: All participants who received a dose of VS-01 on top of SOC, or SOC only (control group).
Respiratory, thoracic and mediastinal disorders Acute pulmonary oedema	11.1% 1/9 • Number of events 1 • Up to Day 90 SAS: All participants who received a dose of VS-01 on top of SOC, or SOC only (control group).	0.00% 0/6 • Up to Day 90 SAS: All participants who received a dose of VS-01 on top of SOC, or SOC only (control group).
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/9 • Up to Day 90 SAS: All participants who received a dose of VS-01 on top of SOC, or SOC only (control group).	16.7% 1/6 • Number of events 1 • Up to Day 90 SAS: All participants who received a dose of VS-01 on top of SOC, or SOC only (control group).
Vascular disorders Arterial haemorrhage	11.1% 1/9 • Number of events 1 • Up to Day 90 SAS: All participants who received a dose of VS-01 on top of SOC, or SOC only (control group).	0.00% 0/6 • Up to Day 90 SAS: All participants who received a dose of VS-01 on top of SOC, or SOC only (control group).
Vascular disorders Circulatory collapse	11.1% 1/9 • Number of events 1 • Up to Day 90 SAS: All participants who received a dose of VS-01 on top of SOC, or SOC only (control group).	0.00% 0/6 • Up to Day 90 SAS: All participants who received a dose of VS-01 on top of SOC, or SOC only (control group).
Vascular disorders Hypotension	11.1% 1/9 • Number of events 1 • Up to Day 90 SAS: All participants who received a dose of VS-01 on top of SOC, or SOC only (control group).	0.00% 0/6 • Up to Day 90 SAS: All participants who received a dose of VS-01 on top of SOC, or SOC only (control group).
Cardiac disorders Cardiac arrest	11.1% 1/9 • Number of events 1 • Up to Day 90 SAS: All participants who received a dose of VS-01 on top of SOC, or SOC only (control group).	0.00% 0/6 • Up to Day 90 SAS: All participants who received a dose of VS-01 on top of SOC, or SOC only (control group).
General disorders Multiple organ dysfunction syndrome	11.1% 1/9 • Number of events 1 • Up to Day 90 SAS: All participants who received a dose of VS-01 on top of SOC, or SOC only (control group).	0.00% 0/6 • Up to Day 90 SAS: All participants who received a dose of VS-01 on top of SOC, or SOC only (control group).
Investigations Haemoglobin decreased	11.1% 1/9 • Number of events 1 • Up to Day 90 SAS: All participants who received a dose of VS-01 on top of SOC, or SOC only (control group).	0.00% 0/6 • Up to Day 90 SAS: All participants who received a dose of VS-01 on top of SOC, or SOC only (control group).
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/9 • Up to Day 90 SAS: All participants who received a dose of VS-01 on top of SOC, or SOC only (control group).	16.7% 1/6 • Number of events 1 • Up to Day 90 SAS: All participants who received a dose of VS-01 on top of SOC, or SOC only (control group).
Psychiatric disorders Mental status changes	0.00% 0/9 • Up to Day 90 SAS: All participants who received a dose of VS-01 on top of SOC, or SOC only (control group).	16.7% 1/6 • Number of events 1 • Up to Day 90 SAS: All participants who received a dose of VS-01 on top of SOC, or SOC only (control group).