Adelaide-based Bionomics (ASX:BNO) has commenced a phase 2 clinical trial of BNC210 in elderly patients with agitation in the hospital setting.
According to the company, agitated behavioural disturbance in elderly patients is a major unmet clinical problem, occurring acutely in hospitalised patients and chronically in nursing home residents.
"These agitated behaviours can cause distress for the patient, distress to other patients, and can interfere with the therapeutic procedures for which the patient was hospitalised. Whilst there are no approved treatments for agitation, current options include benzodiazepines and antipsychotics which can have severe adverse effects in elderly patients including sedation, stroke and sudden death, and hence their use is heavily restricted," said Bionomics in a statement.
BNC210 is a novel, first-in-class, negative allosteric modulator of the alpha-7 nicotinic acetylcholine receptor.
The trial, designed for short treatment and rapid recruitment, will evaluate the effect of BNC210 on the resolution of agitation in hospitalised elderly patients and assess its safety and tolerability. It will recruit approximately 40 elderly patients in specialist geriatric hospital wards across Australia. It is a randomised, double-blind, placebo-controlled design with a 5-day treatment period.
It is expected results of the trial will be available the first quarter of 2019.
“Bionomics has entered an important period with the results of two ongoing Phase 2 trials now anticipated near term. Agitation in the elderly, which has an underlying component of anxiety, has significant unmet treatment needs, with only approximately 9% of patients suffering agitation receiving drug treatment,” said CEO and managing director Dr Deborah Rathjen.
“The hospitalised or nursing home agitation setting represents a rapid potential path to market for BNC210 and builds on the findings of the successful Phase 2 clinical trial of BNC210 in patients with Generalised Anxiety Disorder (GAD)”
“Last month we completed recruitment into our BNC210 Phase 2 clinical trial in patients suffering Post-Traumatic Stress Disorder (PTSD). As previously advised we anticipate data in 2H, CY2018,” added Dr Rathjen.