Trial Outcomes & Findings for SP16 Inflammatory Response Inhibition Trial (NCT NCT04225533)

Last Updated: 2023-01-30

Results Overview

This study will evaluate the anti-inflammatory effect of SP16 by calculating the AUC for CRP. This is done by measuring CRP at baseline, 72 hours, and 14 days. The AUC will then be compared to historical controls to evaluate whether or not SP16 reduces the AUC for CRP.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

10 participants

Primary outcome timeframe

Baseline, 72 hours, 14 days

Results posted on

2023-01-30

Participant Flow

Participant milestones

Participant milestones
Measure	SP16 Patients will receive a single dose of SP16 0.2 mg/kg by subcutaneous injection SP16: All patients will receive a single dose of SP16
Overall Study STARTED	10
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

SP16 Inflammatory Response Inhibition Trial

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	SP16 n=10 Participants Patients will receive a single dose of SP16 0.2 mg/kg by subcutaneous injection SP16: All patients will receive a single dose of SP16
Age, Categorical <=18 years	0 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	10 Participants n=99 Participants
Age, Categorical >=65 years	0 Participants n=99 Participants
Age, Continuous	55 years n=99 Participants
Sex: Female, Male Female	3 Participants n=99 Participants
Sex: Female, Male Male	7 Participants n=99 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=99 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	10 Participants n=99 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants
Race (NIH/OMB) Asian	0 Participants n=99 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants
Race (NIH/OMB) Black or African American	4 Participants n=99 Participants
Race (NIH/OMB) White	6 Participants n=99 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants
Region of Enrollment United States	10 participants n=99 Participants

PRIMARY outcome

Timeframe: Baseline, 72 hours, 14 days

Outcome measures

Outcome measures
Measure	SP16 n=10 Participants Patients will receive a single dose of SP16 0.2 mg/kg by subcutaneous injection SP16: All patients will receive a single dose of SP16
Area Under the Curve (AUC) for C-reactive Protein (CRP)	133 mg*day/L Interval 46.0 to 528.0

SECONDARY outcome

Timeframe: 72 hours

This study will estimate the infarct size based upon area under the curve (AUC) for creatine-kinase myocardial band (CK-MB). The AUC calculation will come from CK-MB levels drawn during usual care. The infarct size will then be compared to historical controls to evaluate whether or not SP16 reduces the infarct size.

Outcome measures

Outcome measures
Measure	SP16 n=10 Participants Patients will receive a single dose of SP16 0.2 mg/kg by subcutaneous injection SP16: All patients will receive a single dose of SP16
Area Under Curve (AUC) for Creatine-Kinase Myocardial Band (CK-MB)	1432 ng/mL*day Interval 675.0 to 3089.0

SECONDARY outcome

Timeframe: 365 days

Patients will undergo transthoracic echocardiography at baseline and 365 days to evaluate the change in LVEF.

Outcome measures

Outcome measures
Measure	SP16 n=8 Participants Patients will receive a single dose of SP16 0.2 mg/kg by subcutaneous injection SP16: All patients will receive a single dose of SP16
Change in Left Ventricular Ejection Fraction (LVEF) at Baseline and 365 Days	5 percentage of LVEF Interval -0.6 to 9.0

SECONDARY outcome

Timeframe: 365 days

Number of participants diagnosed with heart failure at 1 year follow up

Outcome measures

Outcome measures
Measure	SP16 n=10 Participants Patients will receive a single dose of SP16 0.2 mg/kg by subcutaneous injection SP16: All patients will receive a single dose of SP16
Diagnosis of Heart Failure	0 Participants

Adverse Events

SP16

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	SP16 n=10 participants at risk Patients will receive a single dose of SP16 0.2 mg/kg by subcutaneous injection SP16: All patients will receive a single dose of SP16
Cardiac disorders Cardiac disorders	20.0% 2/10 • Number of events 2 • 12 months

Additional Information

Dr. Cohava Gelber

Serpin Pharma, LLC

Phone: 7033433258

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee PI shall be free to publish and/or present about the Study. All publications must be submitted to the sponsor at least 30 days prior to submission for review/comment. PI will consider any such comments in good faith but is under no obligation to incorporate. If Sponsor notifies PI that it desires patent applications, PI will defer Publication for a period not to exceed 60 days; \& if Publication contains Company's Confidential, the PI agrees to delete such Company's Confidential Information.
Publication restrictions are in place

Restriction type: OTHER