Bionomics has started a Phase II clinical trial of BNC210 for treating agitation in elderly patients.

The trial will be conducted in a hospital setting and has already enrolled its first participant.

The randomised, double-blind, placebo-controlled, five-day treatment period trial aims to include around 40 patients in specialist geriatric hospital wards across Australia.

It will examine the effect of BNC210 on the resolution of agitation in hospitalised elderly patients, as well as evaluate the safety and tolerability of BNC210 in this particular patient population.

Results from the trial are scheduled to be released by the first quarter of next year.

Bionomics CEO and managing director Dr Deborah Rathjen said: “Bionomics has entered an important period with the results of two ongoing Phase II trials now anticipated near term.

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“Agitation in the elderly has significant unmet treatment needs, with only approximately 9% of patients suffering agitation receiving drug treatment.”

“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.

“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 II clinical trial of BNC210 in patients with generalised anxiety disorder (GAD).”

Agitated behavioural disturbance in elderly patients occur severely in hospitalised patients and chronically in nursing home residents.

It can result in distress for the patient, distress to other patients, and can interfere with the patients’ ongoing therapeutic procedures.

Currently, there are no approved treatments for agitation.

BNC210 is Bionomics’ therapeutic candidate that is being developed for anxiety and trauma and stressor-related disorders.

It is a new, negative allosteric modulator of the alpha-7 nicotinic acetylcholine receptor and has so far been investigated in seven completed clinical trials in over 200 subjects.