Trial Outcomes & Findings for Phase 2a Study of CG400549 for the Treatment of cABSSSI Caused by Methicillin-resistant Staphylococcus Aureus (NCT NCT01593761)

Last Updated: 2022-09-10

Results Overview

Stable/improving infection, as defined by the Investigator assessment, was defined as cessation of the spread of the redness, edema, and/or induration of the lesion or reduction in the size (length, width, and shortest distance from the peripheral margin of the abscess) of redness, edema, and/or induration and absence of fever (\< 37.7 °C)

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

20 participants

Primary outcome timeframe

Early Clinical Evaluation (ECE, 48 to 72 hours after enrollment)

Results posted on

2022-09-10

Participant Flow

Subjects with complicated acute bacterial skin and skin structure infection were recruited. Study was conducted from June 2012 to October 2012 at 1 site in the United States.

Participant milestones

Participant milestones
Measure	Subjects Received CG400549, MITT All enrolled subjects who received any amount of study drug and was equivalent to the safety population.
Overall Study STARTED	20
Overall Study COMPLETED	12
Overall Study NOT COMPLETED	8

Reasons for withdrawal

Reasons for withdrawal
Measure	Subjects Received CG400549, MITT All enrolled subjects who received any amount of study drug and was equivalent to the safety population.
Overall Study Lost to Follow-up	1
Overall Study culture negative for MRSA at baseline	5
Overall Study positive for hepatitis C virus	1
Overall Study secondary cellulitis	1

Baseline Characteristics

Phase 2a Study of CG400549 for the Treatment of cABSSSI Caused by Methicillin-resistant Staphylococcus Aureus

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Subjects Received CG400549, MITT n=20 Participants All enrolled subjects who received any amount of study drug and was equivalent to the safety population.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	19 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Age, Continuous	35.2 years STANDARD_DEVIATION 13.27 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants
Sex: Female, Male Male	15 Participants n=5 Participants
Region of Enrollment United States	20 participants n=5 Participants

PRIMARY outcome

Timeframe: Early Clinical Evaluation (ECE, 48 to 72 hours after enrollment)

Population: Among 20 participated subjects, 11 subjects had confirmed MRSA and qualified for the mMITT population

Outcome measures

Outcome measures
Measure	Subjects Proven MRSA, mMITT n=11 Participants The primary population for evaluation of the primary endpoint and comprised all MITT subjects who had confirmed MRSA	Subjects Proven MRSA, mMITT The mMITT population was the primary population for evaluation of the primary endpoint and comprised all MITT subjects who had confirmed MRSA
Status of Subject's Clinical Responses Stable/ Improving Infection	10 participants	—
Status of Subject's Clinical Responses No Stable/ Improving Infection	1 participants	—

SECONDARY outcome

Timeframe: End of Treatment (EOT, 10-14 days after beginning treatment) and Test of Cure (TOC, 21-28 days after beginning treatment)

Population: Among 11 mMITT population who had proven MRSA , 2 subjects had major protocol violations, yielding 9 subjects for CE population

1. Clinical cure was defined as absence of fever (\< 37.7°C); presence of granulation or wound healing; resolution of pain; and decreased or resolved erythema, edema,induration, and color. Ulceration could persist, but lesions had to appear non-infected to be defined as clinical cure. 2. Clinical improvement was defined as moderate resolution of 2 or more clinical symptoms. 3. clinical failure was defined as persistence or progression of baseline signs and symptoms of cABSSSI, development of new signs and symptoms consistent with Gram-positive infection, or inability to complete the study because of AEs

Outcome measures

Outcome measures
Measure	Subjects Proven MRSA, mMITT n=9 Participants The primary population for evaluation of the primary endpoint and comprised all MITT subjects who had confirmed MRSA	Subjects Proven MRSA, mMITT The mMITT population was the primary population for evaluation of the primary endpoint and comprised all MITT subjects who had confirmed MRSA
Status of Subject's Clinical Response Clinical Cure at EOT	8 participants Interval 51.8 to 99.7	—
Status of Subject's Clinical Response Clinical Improvement at EOT	1 participants Interval 66.4 to 100.0	—
Status of Subject's Clinical Response Clinical Failure at EOT	0 participants	—
Status of Subject's Clinical Response Clinical Cure at TOC	9 participants	—
Status of Subject's Clinical Response Clinical Improvement at TOC	0 participants	—
Status of Subject's Clinical Response Clinical Failure at TOC	0 participants	—

SECONDARY outcome

Timeframe: End of Treatment (EOT, 10-14 days after beginning treatment) and Test of Cure (TOC, 21-28 days after beginning treatment)

Population: The ME group was not analyzed because the appropriate post-treatment skin culture data were not accessible due to the improvement of infected lesion.

1. Microbial eradication was defined by culture (complete absence of all infecting organisms identified at baseline) or presumed because of an absence of clinical symptoms. 2. Microbiological Persistence was defined as the presence of one or more of the original infecting organisms on the TOC culture or as the absence of cultures in case of clinical failure. 3. Microbiological Recurrence was defined as the presence on the final culture of an original infecting organism whose eradication had been either documented or presumed a the end of therapy.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From time of signing the informed consent to Test of Cure (TOC, 21-28 days after after beginning treatment)

Treatment-Emergent Adverse Event (TEAE) are those that 1. Emerging during treatment, having been absent pre-treatment or 2. Reemerge during treatment, having been present at baseline but stopped prior to treatment or 3. Worsen in severity during treatment relative to the pre-treatment state, when the adverse event is continuous.

Outcome measures

Outcome measures
Measure	Subjects Proven MRSA, mMITT n=20 Participants The primary population for evaluation of the primary endpoint and comprised all MITT subjects who had confirmed MRSA	Subjects Proven MRSA, mMITT n=11 Participants The mMITT population was the primary population for evaluation of the primary endpoint and comprised all MITT subjects who had confirmed MRSA
Overall Summary of Adverse Events Treatment-Emergent Adverse Event (TEAE)	13 participants	10 participants
Overall Summary of Adverse Events Severe TEAE	0 participants	0 participants
Overall Summary of Adverse Events Treatment-Related TEAE	7 participants	5 participants
Overall Summary of Adverse Events Severe Treatment-Related TEAE	0 participants	0 participants
Overall Summary of Adverse Events TEAE with outcome of death	0 participants	0 participants
Overall Summary of Adverse Events TEAE leading to withdrawal of study medic	0 participants	0 participants
Overall Summary of Adverse Events Serious Adverse Event	0 participants	0 participants

SECONDARY outcome

Timeframe: Day 1 predose, Day 1 1hour, Day 1 2hour, Day 1 4hour

The concentrations of CG400549 in plasma collected at each point were analyzed and calculated for its mean plasma concentration.

Outcome measures

Outcome measures
Measure	Subjects Proven MRSA, mMITT n=20 Participants The primary population for evaluation of the primary endpoint and comprised all MITT subjects who had confirmed MRSA	Subjects Proven MRSA, mMITT The mMITT population was the primary population for evaluation of the primary endpoint and comprised all MITT subjects who had confirmed MRSA
Mean Plasma Concentration-time Profile of CG400549 Day 1 predose	32.921 ng/mL Standard Deviation 101.5	—
Mean Plasma Concentration-time Profile of CG400549 Day 1 1hour	426.921 ng/mL Standard Deviation 488.5	—
Mean Plasma Concentration-time Profile of CG400549 Day 1 2hour	1,366.159 ng/mL Standard Deviation 1028.8	—
Mean Plasma Concentration-time Profile of CG400549 Day 1 4hour	1,618.997 ng/mL Standard Deviation 782.3	—

Adverse Events

Subjects Proven MRSA, mMITT

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Subjects Received CG400549, MITT

Serious events: 0 serious events

Other events: 13 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Seonggu Ro, Ph.D, Chief Technology Officer

CrystalGenomics, Inc.

Phone: 82 31 628 2783

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than or equal to 60 days but less than or equal to 120 days from the time submitted to the sponsor for review. The sponsor can request to remove any confidential information (other than study results).
Publication restrictions are in place

Restriction type: OTHER

Measure	Subjects Proven MRSA, mMITT n=11 participants at risk The primary population for evaluation of the primary endpoint and comprised all MITT subjects who had confirmed MRSA	Subjects Received CG400549, MITT n=20 participants at risk All enrolled subjects who received any amount of study drug and was equivalent to the safety population.
Infections and infestations infection	18.2% 2/11 • Serious Adverse Event(SAE) was reported from the time of signing the informed consent, and AE is recorded from the time of the first dose of study drug. AEs and SAEs were recorded until subject's last visit (TOC, day 21-28 after enrollment).	10.0% 2/20 • Serious Adverse Event(SAE) was reported from the time of signing the informed consent, and AE is recorded from the time of the first dose of study drug. AEs and SAEs were recorded until subject's last visit (TOC, day 21-28 after enrollment).
Infections and infestations subcutaneous abscess	9.1% 1/11 • Serious Adverse Event(SAE) was reported from the time of signing the informed consent, and AE is recorded from the time of the first dose of study drug. AEs and SAEs were recorded until subject's last visit (TOC, day 21-28 after enrollment).	10.0% 2/20 • Serious Adverse Event(SAE) was reported from the time of signing the informed consent, and AE is recorded from the time of the first dose of study drug. AEs and SAEs were recorded until subject's last visit (TOC, day 21-28 after enrollment).
Investigations amylase increased	9.1% 1/11 • Serious Adverse Event(SAE) was reported from the time of signing the informed consent, and AE is recorded from the time of the first dose of study drug. AEs and SAEs were recorded until subject's last visit (TOC, day 21-28 after enrollment).	10.0% 2/20 • Serious Adverse Event(SAE) was reported from the time of signing the informed consent, and AE is recorded from the time of the first dose of study drug. AEs and SAEs were recorded until subject's last visit (TOC, day 21-28 after enrollment).
Investigations lipase increased	9.1% 1/11 • Serious Adverse Event(SAE) was reported from the time of signing the informed consent, and AE is recorded from the time of the first dose of study drug. AEs and SAEs were recorded until subject's last visit (TOC, day 21-28 after enrollment).	15.0% 3/20 • Serious Adverse Event(SAE) was reported from the time of signing the informed consent, and AE is recorded from the time of the first dose of study drug. AEs and SAEs were recorded until subject's last visit (TOC, day 21-28 after enrollment).
Cardiac disorders tachycardia	18.2% 2/11 • Serious Adverse Event(SAE) was reported from the time of signing the informed consent, and AE is recorded from the time of the first dose of study drug. AEs and SAEs were recorded until subject's last visit (TOC, day 21-28 after enrollment).	10.0% 2/20 • Serious Adverse Event(SAE) was reported from the time of signing the informed consent, and AE is recorded from the time of the first dose of study drug. AEs and SAEs were recorded until subject's last visit (TOC, day 21-28 after enrollment).
Infections and infestations cellulitis	9.1% 1/11 • Serious Adverse Event(SAE) was reported from the time of signing the informed consent, and AE is recorded from the time of the first dose of study drug. AEs and SAEs were recorded until subject's last visit (TOC, day 21-28 after enrollment).	5.0% 1/20 • Serious Adverse Event(SAE) was reported from the time of signing the informed consent, and AE is recorded from the time of the first dose of study drug. AEs and SAEs were recorded until subject's last visit (TOC, day 21-28 after enrollment).
Infections and infestations impetigo	9.1% 1/11 • Serious Adverse Event(SAE) was reported from the time of signing the informed consent, and AE is recorded from the time of the first dose of study drug. AEs and SAEs were recorded until subject's last visit (TOC, day 21-28 after enrollment).	5.0% 1/20 • Serious Adverse Event(SAE) was reported from the time of signing the informed consent, and AE is recorded from the time of the first dose of study drug. AEs and SAEs were recorded until subject's last visit (TOC, day 21-28 after enrollment).
Infections and infestations injection site cellulitis	9.1% 1/11 • Serious Adverse Event(SAE) was reported from the time of signing the informed consent, and AE is recorded from the time of the first dose of study drug. AEs and SAEs were recorded until subject's last visit (TOC, day 21-28 after enrollment).	5.0% 1/20 • Serious Adverse Event(SAE) was reported from the time of signing the informed consent, and AE is recorded from the time of the first dose of study drug. AEs and SAEs were recorded until subject's last visit (TOC, day 21-28 after enrollment).
Infections and infestations pharyngitis streptococcal	9.1% 1/11 • Serious Adverse Event(SAE) was reported from the time of signing the informed consent, and AE is recorded from the time of the first dose of study drug. AEs and SAEs were recorded until subject's last visit (TOC, day 21-28 after enrollment).	5.0% 1/20 • Serious Adverse Event(SAE) was reported from the time of signing the informed consent, and AE is recorded from the time of the first dose of study drug. AEs and SAEs were recorded until subject's last visit (TOC, day 21-28 after enrollment).
Infections and infestations urinary track infection	9.1% 1/11 • Serious Adverse Event(SAE) was reported from the time of signing the informed consent, and AE is recorded from the time of the first dose of study drug. AEs and SAEs were recorded until subject's last visit (TOC, day 21-28 after enrollment).	5.0% 1/20 • Serious Adverse Event(SAE) was reported from the time of signing the informed consent, and AE is recorded from the time of the first dose of study drug. AEs and SAEs were recorded until subject's last visit (TOC, day 21-28 after enrollment).
Infections and infestations upper respiratory tract infection	9.1% 1/11 • Serious Adverse Event(SAE) was reported from the time of signing the informed consent, and AE is recorded from the time of the first dose of study drug. AEs and SAEs were recorded until subject's last visit (TOC, day 21-28 after enrollment).	5.0% 1/20 • Serious Adverse Event(SAE) was reported from the time of signing the informed consent, and AE is recorded from the time of the first dose of study drug. AEs and SAEs were recorded until subject's last visit (TOC, day 21-28 after enrollment).
Gastrointestinal disorders diarrhoea	9.1% 1/11 • Serious Adverse Event(SAE) was reported from the time of signing the informed consent, and AE is recorded from the time of the first dose of study drug. AEs and SAEs were recorded until subject's last visit (TOC, day 21-28 after enrollment).	5.0% 1/20 • Serious Adverse Event(SAE) was reported from the time of signing the informed consent, and AE is recorded from the time of the first dose of study drug. AEs and SAEs were recorded until subject's last visit (TOC, day 21-28 after enrollment).
Gastrointestinal disorders Nausea	9.1% 1/11 • Serious Adverse Event(SAE) was reported from the time of signing the informed consent, and AE is recorded from the time of the first dose of study drug. AEs and SAEs were recorded until subject's last visit (TOC, day 21-28 after enrollment).	5.0% 1/20 • Serious Adverse Event(SAE) was reported from the time of signing the informed consent, and AE is recorded from the time of the first dose of study drug. AEs and SAEs were recorded until subject's last visit (TOC, day 21-28 after enrollment).
Gastrointestinal disorders vomiting	9.1% 1/11 • Serious Adverse Event(SAE) was reported from the time of signing the informed consent, and AE is recorded from the time of the first dose of study drug. AEs and SAEs were recorded until subject's last visit (TOC, day 21-28 after enrollment).	5.0% 1/20 • Serious Adverse Event(SAE) was reported from the time of signing the informed consent, and AE is recorded from the time of the first dose of study drug. AEs and SAEs were recorded until subject's last visit (TOC, day 21-28 after enrollment).
General disorders pyrexia	18.2% 2/11 • Serious Adverse Event(SAE) was reported from the time of signing the informed consent, and AE is recorded from the time of the first dose of study drug. AEs and SAEs were recorded until subject's last visit (TOC, day 21-28 after enrollment).	10.0% 2/20 • Serious Adverse Event(SAE) was reported from the time of signing the informed consent, and AE is recorded from the time of the first dose of study drug. AEs and SAEs were recorded until subject's last visit (TOC, day 21-28 after enrollment).
General disorders injection site reaction	9.1% 1/11 • Serious Adverse Event(SAE) was reported from the time of signing the informed consent, and AE is recorded from the time of the first dose of study drug. AEs and SAEs were recorded until subject's last visit (TOC, day 21-28 after enrollment).	5.0% 1/20 • Serious Adverse Event(SAE) was reported from the time of signing the informed consent, and AE is recorded from the time of the first dose of study drug. AEs and SAEs were recorded until subject's last visit (TOC, day 21-28 after enrollment).
Nervous system disorders headache	18.2% 2/11 • Serious Adverse Event(SAE) was reported from the time of signing the informed consent, and AE is recorded from the time of the first dose of study drug. AEs and SAEs were recorded until subject's last visit (TOC, day 21-28 after enrollment).	10.0% 2/20 • Serious Adverse Event(SAE) was reported from the time of signing the informed consent, and AE is recorded from the time of the first dose of study drug. AEs and SAEs were recorded until subject's last visit (TOC, day 21-28 after enrollment).
Injury, poisoning and procedural complications ligament sprain	9.1% 1/11 • Serious Adverse Event(SAE) was reported from the time of signing the informed consent, and AE is recorded from the time of the first dose of study drug. AEs and SAEs were recorded until subject's last visit (TOC, day 21-28 after enrollment).	5.0% 1/20 • Serious Adverse Event(SAE) was reported from the time of signing the informed consent, and AE is recorded from the time of the first dose of study drug. AEs and SAEs were recorded until subject's last visit (TOC, day 21-28 after enrollment).
Injury, poisoning and procedural complications muscle strain	9.1% 1/11 • Serious Adverse Event(SAE) was reported from the time of signing the informed consent, and AE is recorded from the time of the first dose of study drug. AEs and SAEs were recorded until subject's last visit (TOC, day 21-28 after enrollment).	5.0% 1/20 • Serious Adverse Event(SAE) was reported from the time of signing the informed consent, and AE is recorded from the time of the first dose of study drug. AEs and SAEs were recorded until subject's last visit (TOC, day 21-28 after enrollment).
Injury, poisoning and procedural complications Road Traffic Accident	9.1% 1/11 • Serious Adverse Event(SAE) was reported from the time of signing the informed consent, and AE is recorded from the time of the first dose of study drug. AEs and SAEs were recorded until subject's last visit (TOC, day 21-28 after enrollment).	5.0% 1/20 • Serious Adverse Event(SAE) was reported from the time of signing the informed consent, and AE is recorded from the time of the first dose of study drug. AEs and SAEs were recorded until subject's last visit (TOC, day 21-28 after enrollment).
Psychiatric disorders abnormal dreams	9.1% 1/11 • Serious Adverse Event(SAE) was reported from the time of signing the informed consent, and AE is recorded from the time of the first dose of study drug. AEs and SAEs were recorded until subject's last visit (TOC, day 21-28 after enrollment).	5.0% 1/20 • Serious Adverse Event(SAE) was reported from the time of signing the informed consent, and AE is recorded from the time of the first dose of study drug. AEs and SAEs were recorded until subject's last visit (TOC, day 21-28 after enrollment).
Respiratory, thoracic and mediastinal disorders cough	9.1% 1/11 • Serious Adverse Event(SAE) was reported from the time of signing the informed consent, and AE is recorded from the time of the first dose of study drug. AEs and SAEs were recorded until subject's last visit (TOC, day 21-28 after enrollment).	5.0% 1/20 • Serious Adverse Event(SAE) was reported from the time of signing the informed consent, and AE is recorded from the time of the first dose of study drug. AEs and SAEs were recorded until subject's last visit (TOC, day 21-28 after enrollment).
Skin and subcutaneous tissue disorders rash	9.1% 1/11 • Serious Adverse Event(SAE) was reported from the time of signing the informed consent, and AE is recorded from the time of the first dose of study drug. AEs and SAEs were recorded until subject's last visit (TOC, day 21-28 after enrollment).	5.0% 1/20 • Serious Adverse Event(SAE) was reported from the time of signing the informed consent, and AE is recorded from the time of the first dose of study drug. AEs and SAEs were recorded until subject's last visit (TOC, day 21-28 after enrollment).