Further analysis provides greater insight into phase 2 findings of Bionomics’ PTSD drug

Biopharmaceutical company Bionomics (ASX: BNO) has reported positive results from further data analysis of a phase two trial involving the BNC210 drug to treat post traumatic stress disorder.

The analysis was conducted in order to improve the company’s understanding of early-stage findings in October which initially showed the drug failed to meet the primary endpoint of a decrease in PTSD symptoms after 12 weeks.

Further analysis has shown the potential for the drug to yield potentially-significant benefits to PTSD patients when the exposure is adequate.

“Our exposure-response modelling has shown the potential for BNC210 to have significant benefit in PTSD provided adequate blood levels are achieved,” said Bionomics executive chairman Dr Errol De Souza.

“Our analysis provides a basis for optimal design of future trials to demonstrate the drug’s efficacy.”

Exposure-response trial

BNC210 is an orally-administered, first-in-class, negative allosteric modulator of the α7 nicotinic acetylcholine receptor and has been developed to treat anxiety, panic, agitation, and PTSD.

The randomised, double-blind, placebo-controlled trial involved 193 adult patients across the US and Australia in a drug exposure versus response environment.

The exposure-response analysis used patient blood levels of the drug, regardless of the administered dose, to relate drug exposure to the response measured in the trial patients.

It used a liquid formulation of BNC210 and patients were required to take the drug with food, however results indicated that the liquid did not give sufficient exposure in an outpatient setting.

The primary endpoint was a decrease in PTSD symptoms between placebo and BNC210 treatment groups at the 12-week mark, as measured by the Clinician-Administered PTSD Scale (or CAPS-5).

CAPS-5 is a structured clinical interview and serves as the research standard for evaluating the severity of PTSD symptoms and as the endpoint mandated by the US Food and Drug Administration (FDA) for PTSD trials.

A pharmacometric analysis conducted post-trial quantified the level of efficacy of BNC210 on the overall CAPS-5 score related to exposure (blood levels) of the drug.

Bionomics will now seek FDA guidance on the next steps for BNC210 as it relates to PTSD treatment, including the design of a further trial and determination of whether BNC210 is eligible for “fast track” designation.

The company is also investigating an improved solid dose formulation of the drug in healthy human volunteers which may overcome the need for it to be taken with food.

The solid dose formulation of BNC210 is anticipated to be used in future PTSD trials.

Unmet medical need

PTSD is associated with changes in brain function and structure and has been recognised in the US as a psycho-biological mental disorder which can affect survivors of military and war events, terrorist attacks, natural disasters, serious accidents, assault or abuse, or major emotional losses.

Statistics show that of the 70% of US adults – or approximately 223.4 million people – who have experienced some type of traumatic event in their lives, up to 20% of them will develop the metal health condition known as PTSD.

The annual cost to society has been estimated to be more than $42.3 billion, often due to misdiagnosis and under treatment and inclusive of costs relating to psychiatric and non-psychiatric medical treatment, indirect workplace effects and prescription drugs.

“There is great unmet medical need for safe and effective treatments for the large population of patients suffering with PTSD worldwide,” Dr De Souza said.

“While challenging to find which symptoms may respond to the novel pharmacological properties of BNC210, there was great anticipation that [the trial] would show clear beneficial effects on improving PTSD symptoms and supporting further development of the drug as a novel treatment for this condition.”

At midday, shares in Bionomics were up 58.33% to $0.19.