Trial Outcomes & Findings for A Phase 2b Study of BNC210 Tablet Formulation in Adults With Post-Traumatic Stress Disorder (PTSD) (NCT NCT04951076)

NCT ID: NCT04951076

Last Updated: 2025-02-06

Results Overview

The CAPS-5 is a 30-item structured interview used to diagnose PTSD and assess PTSD symptoms over the past month. Information about the frequency and intensity of each item is combined into a severity rating, and the CAPS-5 total symptom severity score is calculated by adding the severity scores for the 20 PTSD symptoms in the DSM-5. Scores range from 0 to 80, with higher scores indicating greater severity of PTSD symptoms.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 212 participants
• Primary outcome timeframe: Baseline, 4 weeks, 8 weeks,12 weeks
• Results posted on: 2025-02-06

Participant Flow

Participant milestones

Measure	BNC210 900 mg BNC210 900 mg twice daily (b.i.d.) for 12 weeks	Placebo Placebo twice daily (b.i.d.) for 12 weeks
Overall Study STARTED	106	106
Overall Study Received Any Trial Drug	105	104
Overall Study Modified Intent-To-Treat (mITT)	89	93
Overall Study COMPLETED	57	66
Overall Study NOT COMPLETED	49	40

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Phase 2b Study of BNC210 Tablet Formulation in Adults With Post-Traumatic Stress Disorder (PTSD)

Baseline characteristics by cohort

Measure	BNC210 900 mg n=105 Participants BNC210 900 mg twice daily (b.i.d.) for 12 weeks	Placebo n=104 Participants Placebo twice daily (b.i.d.) for 12 weeks	Total n=209 Participants Total of all reporting groups
Age, Continuous	42.3 years STANDARD_DEVIATION 12.01 • n=5 Participants	42.4 years STANDARD_DEVIATION 12.23 • n=7 Participants	42.3 years STANDARD_DEVIATION 12.09 • n=5 Participants
Sex: Female, Male Female	65 Participants n=5 Participants	69 Participants n=7 Participants	134 Participants n=5 Participants
Sex: Female, Male Male	40 Participants n=5 Participants	35 Participants n=7 Participants	75 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants	0 Participants n=7 Participants	2 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	26 Participants n=5 Participants	24 Participants n=7 Participants	50 Participants n=5 Participants
Race (NIH/OMB) White	72 Participants n=5 Participants	73 Participants n=7 Participants	145 Participants n=5 Participants
Race (NIH/OMB) More than one race	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	4 Participants n=7 Participants	5 Participants n=5 Participants
Region of Enrollment United States	91 participants n=5 Participants	91 participants n=7 Participants	182 participants n=5 Participants
Region of Enrollment United Kingdom	14 participants n=5 Participants	13 participants n=7 Participants	27 participants n=5 Participants
CAPS-5 Score	41.9 Total Symptom Severity Score STANDARD_DEVIATION 7.51 • n=5 Participants	41.1 Total Symptom Severity Score STANDARD_DEVIATION 6.49 • n=7 Participants	41.5 Total Symptom Severity Score STANDARD_DEVIATION 7.01 • n=5 Participants
CGI-S score	4.7 units on a scale STANDARD_DEVIATION 0.64 • n=5 Participants	4.7 units on a scale STANDARD_DEVIATION 0.61 • n=7 Participants	4.7 units on a scale STANDARD_DEVIATION 0.62 • n=5 Participants
Time Since Index Trauma Event	9.1 years STANDARD_DEVIATION 9.1 • n=5 Participants	7.9 years STANDARD_DEVIATION 8.2 • n=7 Participants	8.5 years STANDARD_DEVIATION 8.7 • n=5 Participants

PRIMARY outcome

Timeframe: Baseline, 4 weeks, 8 weeks,12 weeks

The CAPS-5 is a 30-item structured interview used to diagnose PTSD and assess PTSD symptoms over the past month. Information about the frequency and intensity of each item is combined into a severity rating, and the CAPS-5 total symptom severity score is calculated by adding the severity scores for the 20 PTSD symptoms in the DSM-5. Scores range from 0 to 80, with higher scores indicating greater severity of PTSD symptoms.

Outcome measures

Measure	BNC210 900 mg n=89 Participants BNC210 900 mg twice daily (b.i.d.) for 12 weeks	Placebo n=93 Participants Placebo twice daily (b.i.d.) for 12 weeks
Change From Baseline on the Clinician Administered Post-Traumatic Stress Disorder (PTSD) Scale for the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) (CAPS-5) Total Symptom Severity Scores After 12 Weeks	-20.08 score on a scale Standard Error 1.717	-16.05 score on a scale Standard Error 1.469

SECONDARY outcome

Timeframe: Baseline, 4 weeks, 8 weeks, 12 weeks

Criterion B (Intrusive Thoughts) is a 5-item sub section of the CAPS-5 scale that assesses intrusion symptoms associated with the traumatic event(s) of PTSD, with each item rated on a scale from 0 (not present) to 4 (extreme / incapacitating). Scores range from 0 to 20, with higher scores indicating greater severity of intrusion symptoms.

Outcome measures

Measure	BNC210 900 mg n=89 Participants BNC210 900 mg twice daily (b.i.d.) for 12 weeks	Placebo n=93 Participants Placebo twice daily (b.i.d.) for 12 weeks
Change From Baseline on Clinician Administered PTSD Scale for DSM-5 (CAPS-5) Criterion B Symptom Cluster Scores After 12 Weeks	-5.72 score on a scale Standard Error 0.547	-4.40 score on a scale Standard Error 0.472

SECONDARY outcome

Timeframe: Baseline, 4 weeks, 8 weeks, 12 weeks

Criterion C (Avoidance) is a 2-item sub section of the CAPS-5 scale that assesses avoidance of stimuli associated with the traumatic event(s) of PTSD, with each item rated on a scale from 0 (not present) to 4 (extreme / incapacitating). Scores range from 0 to 8, with higher scores indicating greater severity of avoidance symptoms.

Outcome measures

Measure	BNC210 900 mg n=89 Participants BNC210 900 mg twice daily (b.i.d.) for 12 weeks	Placebo n=93 Participants Placebo twice daily (b.i.d.) for 12 weeks
Change From Baseline on Clinician Administered PTSD Scale for DSM-5 (CAPS-5) Criterion C Symptom Cluster Scores After 12 Weeks	-2.28 score on a scale Standard Error 0.299	-1.79 score on a scale Standard Error 0.254

SECONDARY outcome

Timeframe: Baseline, 4 weeks, 8 weeks, 12 weeks

Criterion D (Negative Alterations in Cognitions and Mood) is a 7-item sub section of the CAPS-5 scale that assesses negative alterations in cognitions and mood associated with the traumatic event(s) of PTSD, with each item rated on a scale from 0 (not present) to 4 (extreme / incapacitating). Scores range from 0 to 28, with higher scores indicating greater severity of negative alterations in cognitions and mood symptoms.

Outcome measures

Measure	BNC210 900 mg n=89 Participants BNC210 900 mg twice daily (b.i.d.) for 12 weeks	Placebo n=93 Participants Placebo twice daily (b.i.d.) for 12 weeks
Change From Baseline on Clinician Administered PTSD Scale for DSM-5 (CAPS-5) Criterion D Symptom Cluster Scores After 12 Weeks	-7.77 score on a scale Standard Error 0.790	-5.98 score on a scale Standard Error 0.678

SECONDARY outcome

Timeframe: Baseline, 4 weeks, 8 weeks, 12 weeks

Criterion E (Arousal and Reactivity) is a 6-item sub section of the CAPS-5 scale that assesses marked alterations in arousal and reactivity associated with the traumatic event(s) of PTSD, with each item rated on a scale from 0 (not present) to 4 (extreme / incapacitating). Scores range from 0 to 24, with higher scores indicating greater severity of arousal and reactivity symptoms.

Outcome measures

Measure	BNC210 900 mg n=89 Participants BNC210 900 mg twice daily (b.i.d.) for 12 weeks	Placebo n=93 Participants Placebo twice daily (b.i.d.) for 12 weeks
Change From Baseline on Clinician Administered PTSD Scale for DSM-5 (CAPS-5) Criterion E Symptom Cluster Scores After 12 Weeks	-4.35 score on a scale Standard Error 0.514	-3.98 score on a scale Standard Error 0.436

SECONDARY outcome

Timeframe: Baseline, 4 weeks, 8 weeks, 12 weeks

The MADRS is a 10-item clinician-rated questionnaire to measure the presence and severity of depressive episodes. Each item is rated on a scale of 0 to 6. The score from each item is combined into a total score ranging from 0 to 60, with higher scores indicating greater severity of depressive episodes.

Outcome measures

Measure	BNC210 900 mg n=89 Participants BNC210 900 mg twice daily (b.i.d.) for 12 weeks	Placebo n=93 Participants Placebo twice daily (b.i.d.) for 12 weeks
Change From Baseline on Montgomery Asberg Depression Rating Scale (MADRS) Scores After 12 Weeks	-9.01 score on a scale Standard Error 1.300	-5.82 score on a scale Standard Error 1.105

SECONDARY outcome

Timeframe: Baseline, 4 weeks, 8 weeks, 12 weeks

The HAM-A is an interview questionnaire that measures severity of anxiety symptoms based on 14 parameters, including anxious mood, tension, fears, insomnia, somatic complaints and behavior during the interview. Each parameter is rated on a scale of 0 (not present) to 4 (very severe). The score from each parameter is combined into a total score. Scores range from 0 to 56, with higher scores indicating greater severity of anxiety symptoms.

Outcome measures

Measure	BNC210 900 mg n=89 Participants BNC210 900 mg twice daily (b.i.d.) for 12 weeks	Placebo n=93 Participants Placebo twice daily (b.i.d.) for 12 weeks
Change From Baseline on Hamilton Anxiety Rating Scale (HAM-A) Scores After 12 Weeks	-7.10 score on a scale Standard Error 1.021	-5.14 score on a scale Standard Error 0.875

SECONDARY outcome

Timeframe: Baseline, 4 weeks, 8 weeks, 12 weeks

The CGI-S is a rating scale designed to assess the overall severity of the participant's symptoms. Severity is rated on a scale from 1 (normal, not at all ill) to 7 (among the most extremely ill of participants), with a higher score indicating greater severity of symptoms.

Outcome measures

Measure	BNC210 900 mg n=89 Participants BNC210 900 mg twice daily (b.i.d.) for 12 weeks	Placebo n=93 Participants Placebo twice daily (b.i.d.) for 12 weeks
Change From Baseline on Clinician Global Impression - Severity (CGI-S) Scale Scores After 12 Weeks	-1.47 score on a scale Standard Error 0.173	-1.24 score on a scale Standard Error 0.152

SECONDARY outcome

Timeframe: Baseline, 4 weeks, 8 weeks, 12 weeks

Change from Baseline on patient-reported global functioning

The PGI-S is a patient self-reported counterpart of the CGI-S designed to assess the patient's impression of their perceived severity of overall symptoms.Severity is rated on the PGI-S from 1 (normal) to 6 (very severe), with a higher score indicating greater severity of symptoms.

Outcome measures

Measure	BNC210 900 mg n=89 Participants BNC210 900 mg twice daily (b.i.d.) for 12 weeks	Placebo n=93 Participants Placebo twice daily (b.i.d.) for 12 weeks
Change From Baseline on Patient Global Impression - Severity (PGI-S) Scale Scores After 12 Weeks	-1.25 score on a scale Standard Error 0.165	-0.88 score on a scale Standard Error 0.144

SECONDARY outcome

Timeframe: Baseline, 4 weeks, 8 weeks, 12 weeks

The ISI is a brief self-report instrument measuring both nocturnal and diurnal symptoms of insomnia. The ISI comprises seven items, each scored from 0 to 4. The scores from each of the 7 questions are added up to get a total score of 0 to 28, with a higher score indicating a higher level of symptom severity.

Outcome measures

Measure	BNC210 900 mg n=89 Participants BNC210 900 mg twice daily (b.i.d.) for 12 weeks	Placebo n=93 Participants Placebo twice daily (b.i.d.) for 12 weeks
Change From Baseline on Insomnia Severity Index (ISI) Scores After 12 Weeks	-6.16 score on a scale Standard Error 0.906	-3.97 score on a scale Standard Error 0.767

SECONDARY outcome

Timeframe: Baseline, 4 weeks, 8 weeks,12 weeks

The SDS is a rating scale designed to measure impairment in three domains: work/school, social life, and family life/home responsibilities. Each item is rated on a scale of 0 (not at all) to 10 (extremely), for a total score of 0 to 30, with a higher score indicating a higher degree of impairment.

Outcome measures

Measure	BNC210 900 mg n=89 Participants BNC210 900 mg twice daily (b.i.d.) for 12 weeks	Placebo n=93 Participants Placebo twice daily (b.i.d.) for 12 weeks
Change From Baseline on Sheehan Disability Scale (SDS) Scores After 12 Weeks	-7.76 score on a scale Standard Error 1.033	-6.38 score on a scale Standard Error 0.898

SECONDARY outcome

Timeframe: Baseline, 12 weeks

Population: The number of participants analyzed in the placebo group differs from the total number of participants in the placebo arm in the mITT population due to a missed assessment for 1 participant at Baseline

The PCL-5 is a 20-item self-report assessment of the 20 DSM-5 symptoms of PTSD. Each symptom is rated on a scale from 0 (not at all) to 4 (extremely). Scores range from 0 to 80, with higher scores indicating greater severity of PTSD symptoms.

Outcome measures

Measure	BNC210 900 mg n=89 Participants BNC210 900 mg twice daily (b.i.d.) for 12 weeks	Placebo n=92 Participants Placebo twice daily (b.i.d.) for 12 weeks
Change From Baseline on PTSD Checklist for DSM-5 (PCL-5) Scores After 12 Weeks	-21.81 score on a scale Standard Error 2.768	-18.72 score on a scale Standard Error 2.239

Adverse Events

BNC210 900 mg

Serious events: 0 serious events

Other events: 36 other events

Deaths: 0 deaths

Placebo

Serious events: 2 serious events

Other events: 25 other events

Deaths: 0 deaths

Serious adverse events

Measure	BNC210 900 mg n=105 participants at risk BNC210 900 mg twice daily (b.i.d.) for 12 weeks	Placebo n=104 participants at risk Placebo twice daily (b.i.d.) for 12 weeks
Hepatobiliary disorders Cholelithiasis	0.00% 0/105 • 15 weeks	0.96% 1/104 • Number of events 1 • 15 weeks
Respiratory, thoracic and mediastinal disorders Chronic Obstructive Pulmonary Disease	0.00% 0/105 • 15 weeks	0.96% 1/104 • Number of events 1 • 15 weeks

Other adverse events

Measure	BNC210 900 mg n=105 participants at risk BNC210 900 mg twice daily (b.i.d.) for 12 weeks	Placebo n=104 participants at risk Placebo twice daily (b.i.d.) for 12 weeks
Nervous system disorders Headache	17.1% 18/105 • 15 weeks	12.5% 13/104 • 15 weeks
Gastrointestinal disorders Nausea	12.4% 13/105 • 15 weeks	7.7% 8/104 • 15 weeks
General disorders Fatigue	5.7% 6/105 • 15 weeks	7.7% 8/104 • 15 weeks
Investigations Eleveted Liver Enzymes	13.3% 14/105 • 15 weeks	1.9% 2/104 • 15 weeks

Additional Information

SVP Clinical Development

Bionomics Limited

Phone: +61 8 8150 7400

Email: BNC210clinicalstudies@bionomics.com.au

Results disclosure agreements

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