BNC210: Agitation in the Elderly (Phase 2) - Ongoing

This pilot phase 2 study is evaluating BNC210 in hospitalised elderly patients with agitation and is being conducted in specialist geriatric hospital wards across Australia. Patients enrolled in this randomised, double-blind, placebo-controlled study are treated for five days with either BNC210 or matching placebo. The study is assessing the safety and tolerability of BNC210 in elderly patients, as well as comparing the effect of BNC210 to placebo on agitation in this population. Recruitment to this study has recently been completed.  

Objectives:
Primary
  • To asses safety and tolerability of BNC210 in hospitalised elderly patients with agitation
  • To compare the effect of BNC210 and placebo on agitation in hospitalised elderly patients as measured by the Pittsburgh Agitation Scale (PAS) 
Secondary 
  • To compare the effect of BNC210 and placebo on global function in hospitalised elderly patients as assessed by the Clinical Global Impression Scale
Exploratory
  • To obtain preliminary estimates of pharmacokinetics of BNC210 in elderly patients 
 

BNC210: Post-Traumatic Stress Disorder Study (Phase 2) - Completed

This study evaluated the safety and efficacy of BNC210 in patients with Post-Traumatic Stress Disorder (PTSD) and was conducted across multiple sites in Australia and the USA.  A total of 193 patients were enrolled in this randomised, double-blind, placebo-controlled study. The study compared the effect of three different doses of BNC210 to placebo, on the symptoms of PTSD.  Patients were treated for 12 weeks and were assessed using a variety of psychiatric assessment tools. 

Endpoints:
Primary
  • The effect of BNC210 compared to placebo on Clinician-Administered PTSD Scale (CAPS-5) scores.
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 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.

BNC210: Generalised Anxiety Disorder Study (Phase 2) - Completed

Bionomics has completed a Phase II study in Generalised Anxiety Disorder. The study was conducted at The Institute of Psychiatry, Psychology & Neuroscience at King's College in London. It involved 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, was used as a positive control in this study. Twenty-four (24) subjects were 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. 

Objectives:
Primary
  • To determine whether BNC210 caused significant changes in cerebral perfusion using Arterial Spin Labelling in the resting state.
  • To determine whether BNC210 caused 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 altered 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 ESCALATION STUDY (PHASE 1) - Completed

Bionomics conducted a Phase 1, dose escalation/expansion study in metastatic colorectal cancer patients which was conducted at a number of sites in Australia. The primary objective of the study was to assess safety and tolerability of BNC101. 

Objectives:
Primary
  • To determine the Maximum Tolerated Dose (MTD) of BNC101.
Secondary
  • To determine the Recommended Phase 2 Dose (RP2D) of BNC101 in metastatic colorectal cancer patients
  • To evaluate the safety and tolerability of BNC101
  • To assess for immunogenicity of BNC101
  • To determine the pharmacokinetics of BNC101
  • To make a preliminary assessment of the Overall Response Rate, Progression-Free Survival and Overall Survival of metastatic colorectal cancer patients treated with BNC101
Exploratory
  • To evaluate biomarkers of activity

 

BNC105: COLORECTAL CANCER STUDY (PHASE 2) - ONGOING

Bionomics is supporting an Investigator-Initiated Phase 2 Study in patients with refractory colorectal cancer. This study is being sponsored by the Australian Gastro-Intestinal Trials Group. The study is assessing how effective BNC105 is when given in combination with nivolumab, in treating patients with refractory colorectal cancer. Recruitment to this study is ongoing at a number of sites in Australia. 

Objectives: 
Primary 
  • To determine the Objective Response Rate of the combination of BNC105 and novolumb by immune RECIST (iRECIST)
Secondary
  • To determine the Objective Response Rate of the combination of BNC105 and nivolumab by RECIST1.1
  • To estimate Progression Free Survival
  • To esimate Overall Survival
  • To evaluate the adverse event profile of the drug combination

 

 

BNC105: CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) STUDY (PHASE 1) - ONGOING

Bionomics is supporting an Investigator-Initiated Phase 1 Study in patients with relapsed/refractory chronic lymphocytic leukemia at a single site in the USA. The study is assessing the safety and efficacy of BNC105 when given in combination with ibrutinib, in treating patients with relapsed/refractory chronic lymphocytic leukemia. Recruitment to this study is ongoing.

Objectives: 
Primary
  • To establish the Maximum Tolerated Dose of BNC105P in cominbation with ibrutinib in patients with relapsed/refractory CLL
Secondary
  • To determine the Overall Response Rate of BNC105P in comibination with ibrutinib in patients with relapsed/refractory CLL
  • To determin Event Free Survival of BNC105P in combnation with ibrutinib in patients with relapsed/refractory CLL