BNC210 Brings Significant Improvement in PTSD Symptom Severity

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Bionomics announced the release of the full dataset analysis of the ATTUNE phase 2b trial; the data suggests BNC210 for PTSD could have an advantage over approved medications.

BNC210 Brings Significant Improvement in PTSD Symptom Severity

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Bionomics announced on March 21, 2024, the drug BNC210 exhibited a statistically significant improvement in PTSD symptom severity. The clinically meaningful effect size may indicate BNC10 has a potential advantage over current on-the-market medications.1

Along with the meaningful effect size, the safety and tolerability profile of BNC210 suggests the drug may be a more effective treatment option than other PTSD medications—including ones already approved or also in the experimental stage.

“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,” said Spyros Papapetropoulos, MD, PhD, president and CEO of Bionomics, in a press release. “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.”

In September 2023, Bionomics announced topline results for the phase 2b ATTUNE trial of BNC210 in patients with PTSD, which met its primary endpoint and found the medication was well-tolerated.2 Now, Bionomics has the results of the full dataset analysis from the ATTUNE trial.1

Investigators conducted a phase 2b double-blind, placebo-controlled trial where participants were randomized 1:1 to either receive 900 mg twice daily of BNC210 or placebo. Participants were 18 – 75 years old, had a current PTSD diagnosis defined as a Clinician-Administered PTSD Scale for DSM-5 total symptom severity score of ≥ 30 at screening at baseline, and a ≤ 25% reduction in the score from screening to baseline.

The drug evaluated—BNC210—is a negative allosteric modulator of the a7 nicotinic acetylcholine receptor. BNC210 received the FDA Fast Track designation for the treatment of both PTSD and social anxiety disorder.3

“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,” Papapetropoulos said.1

When assessing the therapeutic effect of BNC210 for patients with PTSD, investigators observed a rapid onset of clinical efficacy by week 4 with an effect size of 0.40 (P < .05). The team continued seeing improvements in symptom severity through week 8 with an effect size of 0.44 (P < .05) and week 12 with an effect size of 0.40 (P < .05).

Intrusion symptoms were significantly improved at weeks 4, 8, and 12, a sign of successful management of PTSD symptoms (Criterion B, P < .05). Furthermore, the team saw statistically significant improvements in negative alterations in cognitions and mood at weeks 4 and 8 (Criterion D, P < .05).

BNC210 treatment also significantly improved depressive symptoms at week 12 and sleep at weeks 4, 8, and 12. Additionally, the treatment demonstrated improvement trends (P < 0.1) across the visits in the following secondary endpoints: clinical and patient global impressions severity scales, the Hamilton Anxiety Rating Scale, and the Sheehan Disability Scale.

BNC210 was demonstrated to be well-tolerated for PTSD patients. Although 66.8% of patients in the BNC210 group reported ≥ 1 treatment-emergent adverse event, most were mild or moderate in severity, and there were no serious adverse events. Additionally, 53.8% of patients in the placebo group reported ≥ 1 treatment-emergent adverse event. The most common side effects with ≤ 5% in each group included headache, nausea, fatigue, and hepatic enzyme increases.

More people in the BNC210 group than the placebo group discontinued (19.8% vs 9.4%, respectively). The top reasons people discontinued the study included adverse events (14.6%), withdrawing consent (9.9%), and not following up (10.4%).

Due to the success of BNC210, Bionomics plans to meet with the FDA to discuss the next steps of research.

“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,” Papapetropoulos said.

References

  1. Dataset Analysis from ATTUNE Phase 2b Trial of BNC210 in Patients with Post-Traumatic Stress Disorder. GlobeNewswire. March 21, 2024. https://www.globenewswire.com/news-release/2024/03/21/2850042/0/en/Bionomics-Reports-Results-of-the-Full-Dataset-Analysis-from-ATTUNE-Phase-2b-Trial-of-BNC210-in-Patients-with-Post-Traumatic-Stress-Disorder.html. Accessed March 21, 2024.
  2. Bionomics Announces Positive Topline Results from the Phase 2b ATTUNE Clinical Trial of BNC210 in Patients with Post-Traumatic Stress Disorder (PTSD). Bionomics. September 28, 2023. https://ir.bionomics.com.au/news-releases/news-release-details/bionomics-announces-positive-topline-results-phase-2b-attune. Accessed March 21, 2024.
  3. Bionomics Reports Promising Full Results Analysis from PREVAIL Phase 2 Study of BNC210 Social Anxiety Disorder (SAD). Bionomics. March 8, 2023. https://ir.bionomics.com.au/news-releases/news-release-details/bionomics-reports-promising-full-results-analysis-prevail-phase. Accessed March 21, 2024.
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