The stock of microcap Bionomics Ltd. rose 103% early Thursday, after the company reported positive results from a mid-stage trial of a treatment for post-traumatic stress disorder.
The company said the Phase 2b trial evaluating BNC210 led to a “statistically significant” reduction in total PTSD symptom severity at 12 weeks. The trial also met its secondary endpoints, showing improvements in depressive symptoms and sleep.
The trial, which was called Attune, involved 212 patients at 34 sites in the U.S. and U.K. who were given either 900 mgs of BNC210 twice daily or a placebo. The patients were aged 18 to 75.
“We are excited about the results of the ATTUNE trial that delivered a positive dataset with treatment effects considerably higher than currently approved therapies,” Bionomics CEO Dr. Spyros Papapetropoulos said in a statement.
The company is hoping the results will enable talks with the U.S. Food and Drug Administration on the registrational path of BNC210 in PTSD, which is an indication with high unmet need, he added.
PTSD is a psychiatric condition brought on by a traumatic event that can create intense, disturbing thoughts and feelings, flashbacks or nightmares, and may lead to a sense of detachment or estrangement from others.
Cambridge, Mass.-based Bionomics recently had a Phase 3 enabling end-of-phase 2 meeting with the FDA for the advancement of BNC201 for the treatment of social anxiety disorder into registrational studies and is now awaiting receipt of the formal meeting minutes.
The stock
BNOX,
has fallen 79% in the year to date, while the S&P 500
SPX
has gained 11.3%.
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