Bionomics Announces Positive Phase 2 ATTUNE Study Results for BNC210 in PTSD in NEJM Evidence

Bionomics Limited (Nasdaq: BNOX), a clinical-stage biotechnology firm based in Adelaide, Australia, and Cambridge, Mass., announced the positive results of its Phase 2 ATTUNE study on BNC210, a treatment for Post-Traumatic Stress Disorder (PTSD). The findings were published in the prestigious NEJM Evidence and presented at the 63rd Annual Meeting of the American College of Neuropsychopharmacology (ACNP).

BNC210 demonstrated significant improvement in PTSD symptom severity by Week 12, with noticeable efficacy as early as Week 4. The study used the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5), which showed a statistically significant improvement (p=0.048) in patients treated with BNC210 compared to those who received a placebo. Additional assessments revealed meaningful improvements in depressive symptoms measured by the Montgomery–Åsberg Depression Rating Scale and sleep quality using the Insomnia Severity Index.

Treatment-emergent adverse events (AEs) were reported in 70 patients (66.7%) in the BNC210 treatment group and 56 patients (53.8%) in the placebo group. The most common AEs included headache, nausea, fatigue, and elevated hepatic enzymes.

Spyros Papapetropoulos, M.D., Ph.D., President and CEO of Bionomics, emphasized the significance of these results, highlighting BNC210's potential as a best- and first-in-class treatment for PTSD. He noted that the drug is non-psychedelic, non-sedating, and non-habit-forming. Following a successful End-of-Phase 2 meeting with the FDA, Bionomics is preparing to initiate a Phase 3 study of BNC210 in the latter half of 2025.

Murray B. Stein, M.D., M.P.H., a senior author of the study and Distinguished Professor of Psychiatry and Public Health at the University of California San Diego, commented on the importance of these findings. He pointed out that current treatments benefit fewer than 50% of patients, thus underscoring the necessity for new, effective, and well-tolerated treatments. Stein expressed optimism about BNC210’s potential and looked forward to further assessments in a larger Phase 3 trial.

In addition to the PTSD study, BNC210 is also being evaluated in a Phase 3 AFIRM-1 study for social anxiety disorder (SAD), with results expected in the third quarter of 2025.

Bionomics is a biotechnology company focused on developing innovative treatments for serious central nervous system disorders. Its leading drug candidate, BNC210, is an oral, selective negative allosteric modulator of the α7 nicotinic acetylcholine receptor. The company is also engaged in a strategic partnership with Merck & Co., Inc. to develop treatments for cognitive deficits in Alzheimer's disease and other CNS conditions. Beyond BNC210, Bionomics has a pipeline that includes preclinical assets targeting Kv3.1/3.2 and Nav1.7/1.8 ion channels for CNS disorders with high unmet needs.