CURRENT TRIALS

BNC210: Post-Traumatic Stress Disorder Study (Phase II)

This study is evaluating the safety and efficacy of BNC210 in patients with Post-Traumatic Stress Disorder (PTSD) and is being conducted across multiple sites in Australia and the USA.  A total of 192 patients are planned to be enrolled in this randomized, double-blind, placebo-controlled study. The study will compare the effect of three different doses of BNC210 to placebo, on the symptoms of PTSD.  Patients will be treated for 12 weeks and will be assessed using a variety of psychiatric and cognitive assessment tools. This study is currently recruiting in Australia and will open soon in the USA. 

Endpoints:
Primary
  • The effect of BNC210 compared to placebo on baseline to endpoint change in Clinician-Administered PTSD Scale (CAPS-5) scores after 12 weeks of treatment.
Secondary
  • The effect of BNC210 on self-reported PTSD symptom severity, depression, anxiety, cognitive function, global function, quality of life, social functioning, and sleep quality after 12 weeks of treatment, when compared to placebo using the following instruments:
    • PTSD Checklist for DSM-5 (PCL-5)
    • Montgomery-Asberg Depression Rating Scale (MADRS) 
    • Hamilton Anxiety Rating Scale (HAM-A)
    • CANTAB Cognitive Assessment
    • Clinical Global Impressions - Severity and Improvement Scale (CGI-S/CGI-I)
    • Patient Global Impression - Severity and Improvement Scale (PGI-S/PGI-I)
    • Assessment of Quality of Life (AQoL-8D) 
    • Social functioning: Sheehan Disability Scale (SDS)
    • Sleep monitoring: Pittsburgh Sleep Quality Index (PSQI)
  • The assessment of safety and tolerability of BNC210 in patients with PTSD.
Exploratory
  • The evaluation of maintenance of effects of BNC210 in the 12-week follow-up period (analysis of investigator-rated and self-reported PTSD symptom severity, depression, anxiety, cognitive function, global function, quality of life, social functioning and sleep quality). 
  • The evaluation of the relationship between nicotine use and the treatment effect of BNC210 compared to placebo. 
  • The evaluation of changes in soluble biomarkers.
  • The evalutation of variations in genetic markers and effects of BNC210.



BNC210: Multiple Ascending Dose Study (Phase I)

Bionomics is conducting a Phase Ib multiple ascending dose study in 54 healthy male volunteers which is being conducted at the clinical trials unit of Biotrial in Rennes, France. Objectives of the study are to assess safety and tolerability of multiple doses of BNC210 on cognitive functions. At the top dose level, the effect of BNC210 on qEEG readings of the brain will be evaluated using a nicotine shift test. Recruitment to this study is complete.

Endpoints:
Primary
  • The primary objective of this study is to assess the safety and tolerability of multiple ascending oral doses of BNC210 in healthy adult male subjects
Secondary
  • Determine the PD profile of multiple ascending oral doses of BNC210 on cognitive functions and of multiple administrations of the highest dose on nicotine shift;
  • Determine the preliminary PK profile of multiple ascending doses of BNC210.

 

BNC210: Generalized Anxiety Disorder Study (Phase II)

The study is being conducted at The Institute of Psychiatry, Psychology & Neuroscience at King's College in London. It involves fMRI with anxiety-provoking images to evaluate drug related changes in brain activity in anxious patients treated with BNC210. Lorazepam, a standard-of-care treatment for patients with GAD, is being used as a positive control in this study. Twenty-four (24) subjects will be involved in the double-blinded, randomized four-way cross-over design trial, with all subjects receiving two single doses of BNC210 (two different dose levels), a single dose of lorazepam and placebo over four periods separated by a week. Recruitment to this study is complete.

Endpoints:
Primary
  • To determine whether BNC210 causes significant changes in cerebral perfusion using Arterial Spin Labelling in the resting state.
  • To determine whether BNC210 causes significant changes in task-related brain activity using the emotional faces task during fMRI.
Secondary
  • To determine the effect of BNC210 on defensive behaviour
  • To determine whether BNC210 alters affective self-report in a way that is consistent with reduced anxiety
  • To contribute safety and tolerability information on BNC210
Exploratory
  • To determine the correlation between BNC210-related brain activity changes and affective self-report.

 

BNC101: DOSE ESCLALTION STUDY (PHASE I)

Bionomics is conducting a Phase I, dose escalation/expansion Study in approximately 50 metastatic colorectal cancer patients which is being conducted at a number of sites in Australia. The primary objective of the study is to assess safety and tolerability of BNC101. This study is currently recruiting.

Endpoints:
Primary
  • To determine the maximum tolerated dose (MTD) of BNC101, both as a single agent and in combination chemotherapy in metastatic colorectal cancer patients.
Secondary
  • To determine the recommended Phase II dose (RP2D) of BNC101, both as single agent and in combination chemotherapy in metastatic colorectal cancer patients
  • To evaluate the safety and tolerability of BNC101 [adverse events (AEs), dose omissions or delays]
  • To assess for immunogenicity of BNC101 (production of antibodies against BNC101)
  • To determine the pharmacokinetics (PK) of BNC101 (half-life, volume of distribution and clearance), both as single agent and in combination with chemotherapy 
  • To make a preliminary assessment of the Overall Response Rate (ORR), Progression-Free Survival (PFS) and Overall Survival (OS) of metastatic colorectal cancer patients treated with BNC101
Exploratory
  • To assess changes in a disease-related biomarker [carcinoembryonic enzyme (CEA)]
  • To evaluate biomarkers of activity [pharmacodynamics, e.g. circulating tumour cells (CTCs), LGR5+ cells, circulating tumour DNA (ctDNA)]