2024-03-21 07:55:00 ET
DENVER, Colo., Mar 21, 2024 ( 247marketnews.com )- Bionomics Limited (NASDAQ: BNOX ) released, this morning, the full dataset analysis from its Phase 2b ATTUNE trial in patients with post-traumatic stress disorder.
The full data analysis shows that ATTUNE achieved its primary and several secondary endpoints, highlighting the potential of BNC210 to address multiple key symptoms experienced by patients with PTSD, and the effects were observed as early as Week 4, supporting potential for rapid onset of clinical efficacy compatible with BNC210’s mechanism of action..
“The full results of the ATTUNE Phase 2b trial further strengthen, the already compelling, topline results and position BNC210 as a potential highly differentiated treatment with rapid onset and durable efficacy that could improve outcomes for patients with PTSD. There are over 13 million Americans adults suffering from PTSD, yet only 20%-30% of them are effectively treated with the currently approved selective serotonin reuptake inhibitors (SSRIs), which not only have slow onset of action but are also associated with many side effects,” said Spyros Papapetropoulos, M.D., Ph.D., President and CEO of Bionomics. “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 favorable effect size compared to approved treatments, and a favorable safety and tolerability profile. We look forward to our discussion with the FDA in the second quarter of 2024 and preparing for initiation of a registrational late-stage trial in PTSD by the end of 2024.”
Bionomics expects late-stage trial initiation by the end of this year and is meeting with the U.S. Food & Drug Administration (FDA) to discuss BNC210’s registrational program in PTSD in the next quarter.
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Bionomics Releases Positive Phase 2b BNC210 Trial Data