Bionomics’ PTSD drug on track for further clinical studies

Bionomics ASX BNO PTSD drug BNC210 further clinical studies
Bionomics has received positive results from a pharmacokinetic study in healthy volunteers using the newly developed solid dose formulation of its lead drug candidate, BNC210.

Biopharma company Bionomics (ASX: BNO) has updated the market with positive news regarding its leading drug candidate BNC210, a potentially new way of treating patients with post-traumatic stress disorder (PTSD).

Earlier this morning, the company reported positive results from a pharmacokinetic study in healthy volunteers using the newly developed solid dose formulation of BNC210.

The drug promises to be a novel, proprietary negative allosteric modulator of the alpha-7 (α7) nicotinic acetylcholine receptor.

BNC210 is an orally administered, first-in-class method of treating anxiety, panic, agitation and PTSD.

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.

Research shows that from the 70% of people that go through tragic and traumatic events in their lives, more than 20% are likely to develop the mental health condition known as PTSD.

The annual cost to society has been estimated to be more than $42.3 billion in the US alone, often exacerbated by misdiagnosis, mistreatment as well as psychiatric treatment, indirect workplace effects and prescription drugs.

Given the results, Bionomics said the “study demonstrated that the solid dose of BNC210 achieved the blood levels predicted as necessary to meet the primary endpoints for effectiveness for treating PTSD patients in future clinical trials.”

The data presented today also dispels previous concerns regarding the failure of the liquid suspension formulation to provide sufficient blood exposure for efficacy in the phase 2 PTSD trial.

Despite earlier concerns that the previous formulation would provide variable absorption and that adequate blood levels could not be achieved, Bionomics said that following a pharmacometric analysis of the PTSD trial data, results showed an “exposure-response relationship” between BNC210 blood levels and CAPS-5 scores, the primary endpoint measure in PTSD trials, and the potential of BNC210 to treat PTSD symptoms.

The new pharmacokinetic data from the single ascending doses of BNC210, along with data reported earlier this year demonstrate that the solid dose formulation can overcome the “food effect”.

Bionomics also reaffirmed that these results show that the solid dose formulation of BNC210 can reach blood levels required to achieve exposures predicted to give clinically meaningful and statistically significant changes from placebo.

Additional propulsion in the US

In addition to progressing its BNC210 drug in Australia, Bionomics is also hoping to test and market the drug in the US.

Less than a week ago, the company announced that had recently attended a supportive Type C meeting with the FDA to discuss the further development of BNC210 using the solid dose formulation for the treatment of PTSD and subsequently submitted a request for Fast Track designation.

Fast Track is a process designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need.

Bionomics’ application outlined the non-clinical and clinical data for BNC210 showing efficacy in animal models representing symptoms of PTSD, such as anxiety and hyperarousal, and an improved safety and tolerability profile compared to the standard of care therapies for PTSD which are typically SSRI drugs such as sertraline and paroxetine.

“The results of this pharmacokinetic clinical trial show that the new solid dose formulation achieves the targeted blood levels to support further development of BNC210 for the treatment of PTSD,” the company said.

Bionomics shares added over 65%, to trade at $0.096 in the morning session.

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