Trial Outcomes & Findings for TNP-2092 to Treat Acute Bacterial Skin and Skin Structure Infection (NCT NCT03964493)

NCT ID: NCT03964493

Last Updated: 2023-12-01

Results Overview

Early clinical response is defined as responder meeting two criteria: (1) patient had at least a 20% reduction of acute bacterial skin and skin structure infection (ABSSSI) primary lesion size compared to baseline measurements; (2) patient did not die of any cause within 72 hours of the first dose of study treatment. An indeterminate classification is used for a response that could not be adequately inferred because study data are unavailable for evaluation of efficacy for any reason (eg, missing data, lost to follow-up, did not attend the EA clinic appointment), or if the early assessment visit is out of the 48 to 72 hours window after the intravenous study treatment starts.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 120 participants
• Primary outcome timeframe: 48 to 72 hours after the first dose of study treatment
• Results posted on: 2023-12-01

Participant Flow

Participant milestones

Measure	TNP-2092 TNP-2092 300 mg intravenous every 12 hours TNP-2092: TNP-2092 100mg/vial	Vancomycin vancomycin 1 g intravenous every 12 hours Vancomycin: Vancomycin 1g/vial
Overall Study STARTED	80	40
Overall Study COMPLETED	63	35
Overall Study NOT COMPLETED	17	5

Reasons for withdrawal

Measure	TNP-2092 TNP-2092 300 mg intravenous every 12 hours TNP-2092: TNP-2092 100mg/vial	Vancomycin vancomycin 1 g intravenous every 12 hours Vancomycin: Vancomycin 1g/vial
Overall Study Withdrawal by Subject	4	1
Overall Study Lost to Follow-up	13	4

Baseline Characteristics

TNP-2092 to Treat Acute Bacterial Skin and Skin Structure Infection

Baseline characteristics by cohort

Measure	TNP-2092 n=80 Participants TNP-2092 300 mg intravenous every 12 hours TNP-2092: TNP-2092 100mg/vial	Vancomycin n=40 Participants vancomycin 1 g intravenous every 12 hours Vancomycin: Vancomycin 1g/vial	Total n=120 Participants Total of all reporting groups
Age, Continuous	41.4 years STANDARD_DEVIATION 11.72 • n=5 Participants	42.7 years STANDARD_DEVIATION 13.16 • n=7 Participants	41.9 years STANDARD_DEVIATION 12.18 • n=5 Participants
Sex: Female, Male Female	19 Participants n=5 Participants	14 Participants n=7 Participants	33 Participants n=5 Participants
Sex: Female, Male Male	61 Participants n=5 Participants	26 Participants n=7 Participants	87 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	32 Participants n=5 Participants	17 Participants n=7 Participants	49 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	48 Participants n=5 Participants	23 Participants n=7 Participants	71 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	3 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 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	5 Participants n=5 Participants	4 Participants n=7 Participants	9 Participants n=5 Participants
Race (NIH/OMB) White	70 Participants n=5 Participants	32 Participants n=7 Participants	102 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	4 Participants n=5 Participants	1 Participants n=7 Participants	5 Participants n=5 Participants
Height	173.5 cm STANDARD_DEVIATION 9.46 • n=5 Participants	170.5 cm STANDARD_DEVIATION 8.32 • n=7 Participants	172.5 cm STANDARD_DEVIATION 9.17 • n=5 Participants
Body mass index	24.1 kg/m^2 STANDARD_DEVIATION 2.98 • n=5 Participants	24.8 kg/m^2 STANDARD_DEVIATION 3.47 • n=7 Participants	24.4 kg/m^2 STANDARD_DEVIATION 3.15 • n=5 Participants
Weight	72.8 kg STANDARD_DEVIATION 11.81 • n=5 Participants	72.7 kg STANDARD_DEVIATION 14.43 • n=7 Participants	72.8 kg STANDARD_DEVIATION 12.68 • n=5 Participants

PRIMARY outcome

Timeframe: 48 to 72 hours after the first dose of study treatment

Population: Intent-to-Treat (mITT) Population: all randomized participants.

Early clinical response is defined as responder meeting two criteria: (1) patient had at least a 20% reduction of acute bacterial skin and skin structure infection (ABSSSI) primary lesion size compared to baseline measurements; (2) patient did not die of any cause within 72 hours of the first dose of study treatment. An indeterminate classification is used for a response that could not be adequately inferred because study data are unavailable for evaluation of efficacy for any reason (eg, missing data, lost to follow-up, did not attend the EA clinic appointment), or if the early assessment visit is out of the 48 to 72 hours window after the intravenous study treatment starts.

Outcome measures

Measure	TNP-2092 n=80 Participants TNP-2092 300 mg intravenous every 12 hours TNP-2092: TNP-2092 100mg/vial	Vancomycin n=40 Participants vancomycin 1 g intravenous every 12 hours Vancomycin: Vancomycin 1g/vial
Early Clinical Response at the Early Assessment (EA) Visit in the Intent-to-Treat (ITT) Population Responder	61 Participants	27 Participants
Early Clinical Response at the Early Assessment (EA) Visit in the Intent-to-Treat (ITT) Population Nonresponder	4 Participants	3 Participants
Early Clinical Response at the Early Assessment (EA) Visit in the Intent-to-Treat (ITT) Population Indeterminate	15 Participants	10 Participants

PRIMARY outcome

Timeframe: 48 to 72 hours after the first dose of study treatment

Population: Modified Intent-to-Treat (mITT) Population: all randomized participants in the ITT population excluding those who have gram-negative pathogens only

Early clinical response is defined as responder meeting two criteria: (1) patient had at least a 20% reduction of acute bacterial skin and skin structure infection (ABSSSI) primary lesion size compared to baseline measurements; (2) patient did not die of any cause within 72 hours of the first dose of study treatment. An indeterminate classification is used for a response that could not be adequately inferred because study data are unavailable for evaluation of efficacy for any reason (eg, missing data, lost to follow-up, did not attend the EA clinic appointment), or if the early assessment visit is out of the 48 to 72 hours window after the intravenous study treatment starts.

Outcome measures

Measure	TNP-2092 n=78 Participants TNP-2092 300 mg intravenous every 12 hours TNP-2092: TNP-2092 100mg/vial	Vancomycin n=40 Participants vancomycin 1 g intravenous every 12 hours Vancomycin: Vancomycin 1g/vial
Early Clinical Response at the Early Assessment Visit in the Modified Intent-to-Treat (mITT) Population Responder	60 Participants	27 Participants
Early Clinical Response at the Early Assessment Visit in the Modified Intent-to-Treat (mITT) Population Nonresponder	4 Participants	3 Participants
Early Clinical Response at the Early Assessment Visit in the Modified Intent-to-Treat (mITT) Population Indeterminate	14 Participants	10 Participants

PRIMARY outcome

Timeframe: 48 to 72 hours after the first dose of study treatment

Population: Micro-Intent-to-Treat (mITT) Population: all randomized participants in the mITT population with culture evidence of a baseline gram-positive ABSSSI pathogens (exclude sole gram negative and culture-negative participants)

Early clinical response is defined as responder meeting two criteria: (1) patient had at least a 20% reduction of acute bacterial skin and skin structure infection (ABSSSI) primary lesion size compared to baseline measurements; (2) patient did not die of any cause within 72 hours of the first dose of study treatment. An indeterminate classification is used for a response that could not be adequately inferred because study data are unavailable for evaluation of efficacy for any reason (eg, missing data, lost to follow-up, did not attend the EA clinic appointment), or if the early assessment visit is out of the 48 to 72 hours window after the intravenous study treatment starts.

Outcome measures

Measure	TNP-2092 n=51 Participants TNP-2092 300 mg intravenous every 12 hours TNP-2092: TNP-2092 100mg/vial	Vancomycin n=29 Participants vancomycin 1 g intravenous every 12 hours Vancomycin: Vancomycin 1g/vial
Early Clinical Response at the Early Assessment Visit in the Micro-Intent-to-Treat (Micro-ITT) Population Responder	41 Participants	19 Participants
Early Clinical Response at the Early Assessment Visit in the Micro-Intent-to-Treat (Micro-ITT) Population Nonresponder	3 Participants	2 Participants
Early Clinical Response at the Early Assessment Visit in the Micro-Intent-to-Treat (Micro-ITT) Population Indeterminate	7 Participants	8 Participants

SECONDARY outcome

Timeframe: 7 to 14 days after the end of study treatment

Population: Modified Intent-to-Treat (mITT) Population: all randomized participants in the ITT population excluding those who have gram-negative pathogens only

At the PTE Visit the investigator indicated one of the following outcomes relating to the primary infection under study: Clinical Success: participant was alive; the ABSSSI sufficiently resolved such that further antibacterial therapy is not needed. Clinical Failure: any of the following: (1)Investigator discontinued study treatment and indicated that the ABSSSI had responded inadequately such that alternative (rescue) non-study antibacterial therapy was needed; (2)participant received antibacterial therapy for a different infection that may be effective for the ABSSSI under study; (3) participant developed an adverse event (AE) that required discontinuation of study treatment before completion of the planned treatment regimen; (4) unplanned major surgical treatment for the ABSSSI under study; (5) participant died of any cause up to the specified visit. Indeterminate: study data are unavailable for evaluation of efficacy for any reason (eg, missing data, lost to follow-up).

Outcome measures

Measure	TNP-2092 n=78 Participants TNP-2092 300 mg intravenous every 12 hours TNP-2092: TNP-2092 100mg/vial	Vancomycin n=40 Participants vancomycin 1 g intravenous every 12 hours Vancomycin: Vancomycin 1g/vial
Investigator Assessment of Clinical Response at Post Treatment Evaluation (PTE) Visit in the mITT Population Success	62 Participants	31 Participants
Investigator Assessment of Clinical Response at Post Treatment Evaluation (PTE) Visit in the mITT Population Failure	2 Participants	3 Participants
Investigator Assessment of Clinical Response at Post Treatment Evaluation (PTE) Visit in the mITT Population Indeterminate	14 Participants	6 Participants

SECONDARY outcome

Timeframe: 7 to 14 days after the end of study treatment

Population: Micro-Intent-to-Treat (mITT) Population: all randomized participants in the mITT population with culture evidence of a baseline gram-positive ABSSSI pathogens (exclude sole gram negative and culture-negative participants)

At the PTE Visit the investigator indicated one of the following outcomes relating to the primary infection under study: Clinical Success: participant was alive; the ABSSSI sufficiently resolved such that further antibacterial therapy is not needed. Clinical Failure: any of the following: (1)Investigator discontinued study treatment and indicated that the ABSSSI had responded inadequately such that alternative (rescue) non-study antibacterial therapy was needed; (2)participant received antibacterial therapy for a different infection that may be effective for the ABSSSI under study; (3) participant developed an adverse event (AE) that required discontinuation of study treatment before completion of the planned treatment regimen; (4) unplanned major surgical treatment for the ABSSSI under study; (5) participant died of any cause up to the specified visit. Indeterminate: study data are unavailable for evaluation of efficacy for any reason (eg, missing data, lost to follow-up).

Outcome measures

Measure	TNP-2092 n=51 Participants TNP-2092 300 mg intravenous every 12 hours TNP-2092: TNP-2092 100mg/vial	Vancomycin n=29 Participants vancomycin 1 g intravenous every 12 hours Vancomycin: Vancomycin 1g/vial
Investigator Assessment of Clinical Response at Post Treatment Evaluation (PTE) Visit in the Micro-ITT Population Success	40 Participants	23 Participants
Investigator Assessment of Clinical Response at Post Treatment Evaluation (PTE) Visit in the Micro-ITT Population Failure	2 Participants	1 Participants
Investigator Assessment of Clinical Response at Post Treatment Evaluation (PTE) Visit in the Micro-ITT Population Indeterminate	9 Participants	5 Participants

SECONDARY outcome

Timeframe: After a minimum of 7 days up to 14 days of study treatment

Population: Modified Intent-to-Treat (mITT) Population: all randomized participants in the ITT population excluding those who have gram-negative pathogens only

At the EOT Visit the investigator indicated one of the following outcomes relating to the primary infection under study: Clinical Success: participant was alive; the ABSSSI sufficiently resolved such that further antibacterial therapy is not needed. Clinical Failure: any of the following: (1)Investigator discontinued study treatment and indicated that the ABSSSI had responded inadequately such that alternative (rescue) non-study antibacterial therapy was needed; (2)participant received antibacterial therapy for a different infection that may be effective for the ABSSSI under study; (3) participant developed an adverse event (AE) that required discontinuation of study treatment before completion of the planned treatment regimen; (4) unplanned major surgical treatment for the ABSSSI under study; (5) participant died of any cause up to the specified visit. Indeterminate: study data are unavailable for evaluation of efficacy for any reason (eg, missing data, lost to follow-up).

Outcome measures

Measure	TNP-2092 n=78 Participants TNP-2092 300 mg intravenous every 12 hours TNP-2092: TNP-2092 100mg/vial	Vancomycin n=40 Participants vancomycin 1 g intravenous every 12 hours Vancomycin: Vancomycin 1g/vial
Investigator's Assessment of Clinical Response at the End of Treatment (EOT) Visit in the mITT Population Success	68 Participants	31 Participants
Investigator's Assessment of Clinical Response at the End of Treatment (EOT) Visit in the mITT Population Failure	2 Participants	3 Participants
Investigator's Assessment of Clinical Response at the End of Treatment (EOT) Visit in the mITT Population Indeterminate	8 Participants	6 Participants

SECONDARY outcome

Timeframe: After a minimum of 7 days up to 14 days of study treatment

Population: Micro-Intent-to-Treat (mITT) Population: all randomized participants in the mITT population with culture evidence of a baseline gram-positive ABSSSI pathogens (exclude sole gram negative and culture-negative participants)

At the EOT Visit the investigator indicated one of the following outcomes relating to the primary infection under study: Clinical Success: participant was alive; the ABSSSI sufficiently resolved such that further antibacterial therapy is not needed. Clinical Failure: any of the following: (1)Investigator discontinued study treatment and indicated that the ABSSSI had responded inadequately such that alternative (rescue) non-study antibacterial therapy was needed; (2)participant received antibacterial therapy for a different infection that may be effective for the ABSSSI under study; (3) participant developed an adverse event (AE) that required discontinuation of study treatment before completion of the planned treatment regimen; (4) unplanned major surgical treatment for the ABSSSI under study; (5) participant died of any cause up to the specified visit. Indeterminate: study data are unavailable for evaluation of efficacy for any reason (eg, missing data, lost to follow-up).

Outcome measures

Measure	TNP-2092 n=51 Participants TNP-2092 300 mg intravenous every 12 hours TNP-2092: TNP-2092 100mg/vial	Vancomycin n=29 Participants vancomycin 1 g intravenous every 12 hours Vancomycin: Vancomycin 1g/vial
Investigator's Assessment of Clinical Response at the End of Treatment (EOT) Visit in the Micro-ITT Population Success	45 Participants	23 Participants
Investigator's Assessment of Clinical Response at the End of Treatment (EOT) Visit in the Micro-ITT Population Failure	2 Participants	1 Participants
Investigator's Assessment of Clinical Response at the End of Treatment (EOT) Visit in the Micro-ITT Population Indeterminate	4 Participants	5 Participants

SECONDARY outcome

Timeframe: 0 to 12 hours post-dose

Population: Participants that have sufficient plasma points for AUC 0-12h after first infusion analysis (26 Participants).

Partial area under the concentration versus time curve from time zero to time 12 hours.

Outcome measures

Measure	TNP-2092 n=26 Participants TNP-2092 300 mg intravenous every 12 hours TNP-2092: TNP-2092 100mg/vial	Vancomycin vancomycin 1 g intravenous every 12 hours Vancomycin: Vancomycin 1g/vial
AUC0-12h After First Infusion	135000 h*ng/mL Standard Deviation 38200	—

SECONDARY outcome

Timeframe: 0 to 12 hours post-dose

Population: Participants that have sufficient plasma points for AUC 0-12h after last infusion analysis (39 Participants)

Partial area under the concentration versus time curve from time zero to time 12 hours

Outcome measures

Measure	TNP-2092 n=39 Participants TNP-2092 300 mg intravenous every 12 hours TNP-2092: TNP-2092 100mg/vial	Vancomycin vancomycin 1 g intravenous every 12 hours Vancomycin: Vancomycin 1g/vial
AUC0-12h After Last Infusion	159000 h*ng/mL Standard Deviation 74200	—

SECONDARY outcome

Timeframe: 57 to 60 minutes, 1.5 to 3 hours, 4 to 6 hours, 12 hours, after the last infusion

Population: Participants that have sufficient plasma points for Cmax after last infusion analysis (58 Participants)

Maximum observed concentration

Outcome measures

Measure	TNP-2092 n=58 Participants TNP-2092 300 mg intravenous every 12 hours TNP-2092: TNP-2092 100mg/vial	Vancomycin vancomycin 1 g intravenous every 12 hours Vancomycin: Vancomycin 1g/vial
Cmax After Last Infusion	38500 ng/mL Standard Deviation 13400	—

SECONDARY outcome

Timeframe: 57 to 60 minutes, 1.5 to 3 hours, 4 to 6 hours, 12 hours, after the first infusion

Population: Participants that have sufficient plasma points for Cmax after first infusion analysis (68 Participants)

Maximum observed concentration

Outcome measures

Measure	TNP-2092 n=68 Participants TNP-2092 300 mg intravenous every 12 hours TNP-2092: TNP-2092 100mg/vial	Vancomycin vancomycin 1 g intravenous every 12 hours Vancomycin: Vancomycin 1g/vial
Cmax After First Infusion	37500 ng/mL Standard Deviation 13500	—

Adverse Events

TNP-2092

Serious events: 1 serious events

Other events: 27 other events

Deaths: 0 deaths

Vancomycin

Serious events: 2 serious events

Other events: 11 other events

Deaths: 0 deaths

Serious adverse events

Measure	TNP-2092 n=78 participants at risk TNP-2092 300 mg intravenous every 12 hours TNP-2092: TNP-2092 100mg/vial	Vancomycin n=39 participants at risk vancomycin 1 g intravenous every 12 hours Vancomycin: Vancomycin 1g/vial
Skin and subcutaneous tissue disorders MRSA bacteremia and worsening cellulitis	1.3% 1/78 • Number of events 1 • Adverse events were assessed from the first day of study treatment (day 1) to long-term follow-up visit(20 to 25 days after end of treatment), A Serious Adverse event (SAE) will be followed until resolution, stabilization, the event is otherwise explained, or the participant is lost to follow-up. Adverse events are reported for members of the Safety Population, comprised of all randomized participants who received any amount of study treatment. Treatment-emergent adverse events, defined as events occurring after initiation of study treatment, are reported.	0.00% 0/39 • Adverse events were assessed from the first day of study treatment (day 1) to long-term follow-up visit(20 to 25 days after end of treatment), A Serious Adverse event (SAE) will be followed until resolution, stabilization, the event is otherwise explained, or the participant is lost to follow-up. Adverse events are reported for members of the Safety Population, comprised of all randomized participants who received any amount of study treatment. Treatment-emergent adverse events, defined as events occurring after initiation of study treatment, are reported.
Psychiatric disorders mental status changes	0.00% 0/78 • Adverse events were assessed from the first day of study treatment (day 1) to long-term follow-up visit(20 to 25 days after end of treatment), A Serious Adverse event (SAE) will be followed until resolution, stabilization, the event is otherwise explained, or the participant is lost to follow-up. Adverse events are reported for members of the Safety Population, comprised of all randomized participants who received any amount of study treatment. Treatment-emergent adverse events, defined as events occurring after initiation of study treatment, are reported.	2.6% 1/39 • Number of events 1 • Adverse events were assessed from the first day of study treatment (day 1) to long-term follow-up visit(20 to 25 days after end of treatment), A Serious Adverse event (SAE) will be followed until resolution, stabilization, the event is otherwise explained, or the participant is lost to follow-up. Adverse events are reported for members of the Safety Population, comprised of all randomized participants who received any amount of study treatment. Treatment-emergent adverse events, defined as events occurring after initiation of study treatment, are reported.
Skin and subcutaneous tissue disorders left upper extremity abscess,dehydration	0.00% 0/78 • Adverse events were assessed from the first day of study treatment (day 1) to long-term follow-up visit(20 to 25 days after end of treatment), A Serious Adverse event (SAE) will be followed until resolution, stabilization, the event is otherwise explained, or the participant is lost to follow-up. Adverse events are reported for members of the Safety Population, comprised of all randomized participants who received any amount of study treatment. Treatment-emergent adverse events, defined as events occurring after initiation of study treatment, are reported.	2.6% 1/39 • Number of events 2 • Adverse events were assessed from the first day of study treatment (day 1) to long-term follow-up visit(20 to 25 days after end of treatment), A Serious Adverse event (SAE) will be followed until resolution, stabilization, the event is otherwise explained, or the participant is lost to follow-up. Adverse events are reported for members of the Safety Population, comprised of all randomized participants who received any amount of study treatment. Treatment-emergent adverse events, defined as events occurring after initiation of study treatment, are reported.

Other adverse events

Measure	TNP-2092 n=78 participants at risk TNP-2092 300 mg intravenous every 12 hours TNP-2092: TNP-2092 100mg/vial	Vancomycin n=39 participants at risk vancomycin 1 g intravenous every 12 hours Vancomycin: Vancomycin 1g/vial
Gastrointestinal disorders Nausea	15.4% 12/78 • Number of events 12 • Adverse events were assessed from the first day of study treatment (day 1) to long-term follow-up visit(20 to 25 days after end of treatment), A Serious Adverse event (SAE) will be followed until resolution, stabilization, the event is otherwise explained, or the participant is lost to follow-up. Adverse events are reported for members of the Safety Population, comprised of all randomized participants who received any amount of study treatment. Treatment-emergent adverse events, defined as events occurring after initiation of study treatment, are reported.	5.1% 2/39 • Number of events 2 • Adverse events were assessed from the first day of study treatment (day 1) to long-term follow-up visit(20 to 25 days after end of treatment), A Serious Adverse event (SAE) will be followed until resolution, stabilization, the event is otherwise explained, or the participant is lost to follow-up. Adverse events are reported for members of the Safety Population, comprised of all randomized participants who received any amount of study treatment. Treatment-emergent adverse events, defined as events occurring after initiation of study treatment, are reported.
Skin and subcutaneous tissue disorders Cellulitis	9.0% 7/78 • Number of events 7 • Adverse events were assessed from the first day of study treatment (day 1) to long-term follow-up visit(20 to 25 days after end of treatment), A Serious Adverse event (SAE) will be followed until resolution, stabilization, the event is otherwise explained, or the participant is lost to follow-up. Adverse events are reported for members of the Safety Population, comprised of all randomized participants who received any amount of study treatment. Treatment-emergent adverse events, defined as events occurring after initiation of study treatment, are reported.	12.8% 5/39 • Number of events 5 • Adverse events were assessed from the first day of study treatment (day 1) to long-term follow-up visit(20 to 25 days after end of treatment), A Serious Adverse event (SAE) will be followed until resolution, stabilization, the event is otherwise explained, or the participant is lost to follow-up. Adverse events are reported for members of the Safety Population, comprised of all randomized participants who received any amount of study treatment. Treatment-emergent adverse events, defined as events occurring after initiation of study treatment, are reported.
Infections and infestations Wound infection	2.6% 2/78 • Number of events 2 • Adverse events were assessed from the first day of study treatment (day 1) to long-term follow-up visit(20 to 25 days after end of treatment), A Serious Adverse event (SAE) will be followed until resolution, stabilization, the event is otherwise explained, or the participant is lost to follow-up. Adverse events are reported for members of the Safety Population, comprised of all randomized participants who received any amount of study treatment. Treatment-emergent adverse events, defined as events occurring after initiation of study treatment, are reported.	5.1% 2/39 • Number of events 2 • Adverse events were assessed from the first day of study treatment (day 1) to long-term follow-up visit(20 to 25 days after end of treatment), A Serious Adverse event (SAE) will be followed until resolution, stabilization, the event is otherwise explained, or the participant is lost to follow-up. Adverse events are reported for members of the Safety Population, comprised of all randomized participants who received any amount of study treatment. Treatment-emergent adverse events, defined as events occurring after initiation of study treatment, are reported.
Gastrointestinal disorders Vomiting	7.7% 6/78 • Number of events 6 • Adverse events were assessed from the first day of study treatment (day 1) to long-term follow-up visit(20 to 25 days after end of treatment), A Serious Adverse event (SAE) will be followed until resolution, stabilization, the event is otherwise explained, or the participant is lost to follow-up. Adverse events are reported for members of the Safety Population, comprised of all randomized participants who received any amount of study treatment. Treatment-emergent adverse events, defined as events occurring after initiation of study treatment, are reported.	5.1% 2/39 • Number of events 2 • Adverse events were assessed from the first day of study treatment (day 1) to long-term follow-up visit(20 to 25 days after end of treatment), A Serious Adverse event (SAE) will be followed until resolution, stabilization, the event is otherwise explained, or the participant is lost to follow-up. Adverse events are reported for members of the Safety Population, comprised of all randomized participants who received any amount of study treatment. Treatment-emergent adverse events, defined as events occurring after initiation of study treatment, are reported.

Additional Information

Zhenkun Ma, PhD / CEO

TenNor Therapeutics Limited

Phone: +1(646) 775-1861

Email: zhenkun.ma@tennorx.com

Results disclosure agreements

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