Bionomics has announced plans to meet with the US Food & Drug Administration (FDA) in Q2 2024 following the release of positive topline data from a Phase IIb trial of its lead candidate BNC210 to treat post-traumatic stress disorder (PTSD). 

Full topline data has been released from the Phase IIb ATTUNE trial (NCT04951076), with Bionomics previously reporting in September 2023 that the trial had met its primary endpoint and several secondary endpoints. Subjects were randomised in a 1:1 ratio to receive either placebo or 900mg of BNC210, given twice a day as a monotherapy. 

The primary endpoint, measured by the change from baseline in Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) total symptom severity score, showed a statistically significant improvement with BNC210 compared to placebo after 12 weeks, with an effect size of 0.40. This improvement was observed at week four and continued through week eight. Key secondary endpoints were also met, including depressive symptoms as measured by the Montgomery-Åsberg Depression Rating Scale (MADRS) at week 12, and sleep as measured by the Insomnia Severity Index (ISI) at weeks four, eight and 12. 

Bionomics will meet with the FDA to discuss BNC210’s registrational program in PTSD by the end of Q2 2024, and then initiate a late-stage trial likely by the end of this year. 

BNC210, a negative allosteric modulator of the α7 nicotinic acetylcholine receptor (nAChR), received an FDA fast track designation for the treatment of PTSD, anxiety, and other trauma and stressor-related disorders in 2021. According to GlobalData’s Pharma Intelligence Center, BNC210 is forecast to generate $352m in 2029. In the seven major pharmaceutical markets (France, Germany, Italy, Japan, Spain, UK, and the US), GlobalData epidemiologists estimate that there will be more than 1.19 million cases of PTSD in 2028. 

GlobalData is the parent company of Pharmaceutical Technology. 

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Current PTSD treatments centre around selective serotonin reuptake inhibitors (SSRIs), such as Pfizer’s Zoloft (sertraline) and GSK’s Paxil (paroxetine). However, these can have a slow onset of action and are associated with many side effects, said Bionomics CEO Spyros Papapetropoulos in the 21 March press release. In the ATTUNE trial, there were no reports of sexual side effects that are commonly associated with SSRI treatment, such as decreased libido and erectile dysfunction. 

“BNC210 is the only non-psychedelic experimental therapeutic with a novel mechanism of action that has generated evidence of a clinically meaningful improvement in PTSD total symptom severity, with a favourable effect size compared to approved treatments, and a favourable safety and tolerability profile,” adds Papapetropoulos. 

Beyond BNC210, Bionomics has an ongoing collaboration with MSD to identify novel α7 nAChR positive allosteric modulators, with two drugs in early-stage clinical trials for the treatment of cognitive deficits in Alzheimer’s disease and other central nervous system conditions.