Bionomics to Pursue FDA Meeting for PTSD Drug Following Positive Phase IIb Results

Australian biopharmaceutical company Bionomics has revealed its intentions to engage with the US Food & Drug Administration (FDA) in the second quarter of 2024 subsequent to unveiling positive topline data from a Phase IIb trial involving its lead candidate, BNC210, for the treatment of post-traumatic stress disorder (PTSD).

The Phase IIb trial, coded as ATTUNE (NCT04951076), has now released complete topline data. Bionomics had previously disclosed in September 2023 that the trial successfully achieved its primary objective along with various secondary endpoints. The study involved randomising participants at a 1:1 ratio to receive either a placebo or 900mg of BNC210, administered twice daily as a standalone treatment.

The primary endpoint, assessed by the alteration in Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) total symptom severity score from baseline, demonstrated a statistically significant enhancement with BNC210 versus placebo after a 12-week period, exhibiting an effect size of 0.40. This improvement was noticeable by the fourth week and continued through the eighth week. Several key secondary endpoints were also met, including depressive symptoms measured by the Montgomery-Åsberg Depression Rating Scale (MADRS) at week 12, and sleep evaluated by the Insomnia Severity Index (ISI) at weeks four, eight, and 12.

Bionomics is scheduled to hold discussions with the FDA concerning BNC210’s registrational program for PTSD by the conclusion of Q2 2024, followed by the anticipated initiation of a late-stage trial likely by the end of this year.

BNC210, functioning as a negative allosteric modulator of the α7 nicotinic acetylcholine receptor (nAChR), secured an FDA fast track designation for treating PTSD, anxiety, and other trauma and stressor-related disorders in 2021. According to GlobalData‘s Pharma Intelligence Center, the revenue forecast for BNC210 stands at $352m by 2029. In the seven major pharmaceutical markets (France, Germany, Italy, Japan, Spain, UK, and the US), GlobalData epidemiologists estimate over 1.19 million PTSD cases in 2028.

Current PTSD therapies predominantly revolve around selective serotonin reuptake inhibitors (SSRIs) such as Pfizer‘s Zoloft (sertraline) and GlaxoSmithKline‘s Paxil (paroxetine). However, Bionomics CEO Spyros Papapetropoulos highlighted their slow onset of action and numerous associated side effects. Noteworthy is the absence of reports on sexual side effects in the ATTUNE trial linked to SSRI treatments, like decreased libido and erectile dysfunction.

Papapetropoulos emphasized, “BNC210 is the sole non-psychedelic experimental therapy with a novel mechanism of action that has displayed evidence of clinically meaningful improvement in PTSD total symptom severity, boasting a favorable effect size compared to sanctioned treatments and a favorable safety and tolerability profile.”

Besides BNC210, Bionomics maintains an ongoing collaboration with MSD to identify novel α7 nAChR positive allosteric modulators, with two medications in early clinical trials designated for addressing cognitive impairments in Alzheimer's disease and other central nervous system disorders.