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Bionomics to advance non-SSRI PTSD candidate to Phase III

2024-03-21

临床2期临床结果临床3期快速通道

PTSD is a mental health condition that is triggered by an event, characterised by symptoms of severe anxiety. Credit: PopTika via Shutterstock.

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

Bionomicsine data has been released from the PhaseFood & Drug Administration (FDA) with Bionomics previously reporting in September 2023 that the trial had met its primary endpoint and sBNC210 secondarypost-traumatic stress disorder (PTSD)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 PTSBionomicsor 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 obBNC210 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 bPTSDe end of Q2 2024, and then initiate a late-stage trial likely by the end of this year.BNC210 Depression Insomnia

Bionomics negative allostericFDAdulator of tBNC210nicotinic acetylcholine recepPTSD(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.

BNC210so:α7 nicotinic acetylcholine receptor (nAChR)FDA PTSD anxiety Pharma Intelligence Center BNC210 PTSD

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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 Pharmaceutical Technologywith 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 BPTSD0, Bionomics has an ongoing collaboration with MSD to identify novel α7 nAChR positPfizerlosZoloftmosertralinewith tGSKdrugs in early-stage clinical trials for the treatment of cognitive deficits in Alzheimer’s disease and other central Bionomicsystem conditions.erectile dysfunction

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