Bionomics Reveals Detailed Data From PTSD Trial, Stock Soars

Thursday, Bionomics Limited BNOX released a full dataset analysis from its Phase 2b ATTUNE trial of BNC210 in patients with post-traumatic stress disorder (PTSD).

In September 2023, Bionomics reported the topline results for the Phase 2b ATTUNE trial of BNC210 for PTSD, demonstrating that the trial met its primary endpoint and several secondary endpoints and that BNC210 was generally well tolerated. 

The primary endpoint of mean change from baseline in the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) total symptom severity score was met, showing that BNC210 led to a statistically significant improvement vs placebo (p<0.05) at Week 12 with an effect size of 0.40. 

The improvement in CAPS-5 score was observed as early as Week 4 and continued through Week 8 (p<0.05, effect size 0.44) till the end of the treatment period.

Additionally, statistically significant results were achieved for negative alterations in cognition and mood at Week 4 and Week 8.

Treatment with BNC210 led to statistically significant improvement (p<0.05) in the following secondary endpoints: depressive symptoms at Week 12 and sleep at Weeks 4, 8, and 12.

BNC210 treatment showed improvement trends (p<0.1) across visits in the other secondary endpoints, including the clinical and patient global impressions severity scales, the Hamilton Anxiety Rating scale, and the Sheehan Disability Scale.

Overall, BNC210 continued to demonstrate a favorable safety profile for a psychoactive experimental therapeutic.

66.7% of patients in the BNC210 arm and 53.8% in the placebo arm reported at least one treatment-emergent adverse event. Most AEs were mild or moderate. No serious AEs were reported with BNC210. 

Upon trial completion, no withdrawal symptoms were reported.

Following the ATTUNE Phase 2b trial readout and based on a safety database of ~600 patients, BNC210 continues to demonstrate a non-sedating, non-habit forming, non-cognition impairing psychoactive profile.

In addition to the 900 mg twice daily dose, a lower BNC210 dose that may alleviate hepatic enzyme elevations will be tested in a subsequent late-stage clinical trial.

Bionomics plans to discuss the Phase 2b ATTUNE results with the FDA in Q2 2024 and proceed to a late-stage trial in the fourth quarter of 2024.

Price Action: BNOX shares are down 1.09% at $1.03 after reaching as high as $1.30 during the premarket session on Thursday.