Bionomics Publishes the Positive Results from the Phase 2 ATTUNE Study of BNC210 in Patients with Post-Traumatic Stress Disorder in NEJM Evidence

Rhea-AI Summary

Bionomics (NASDAQ: BNOX) has published positive Phase 2 ATTUNE study results for BNC210 in PTSD patients in NEJM Evidence. The study showed significant improvements in PTSD symptom severity at Week 12, with efficacy observed as early as Week 4. Key findings include improvements in the Clinician-Administered PTSD Scale (CAPS-5) scores, depressive symptoms, and sleep quality.

BNC210, positioned as a non-psychedelic, non-sedating, and non-habit-forming treatment, demonstrated a manageable safety profile. Common adverse events included headache, nausea, fatigue, and hepatic enzyme elevations, occurring in 66.7% of BNC210 patients versus 53.8% in the placebo group. The company plans to initiate a Phase 3 study in H2 2025 and is currently conducting a Phase 3 AFIRM-1 study in social anxiety disorder with results expected in Q3 2025.

Positive

• Successful Phase 2 ATTUNE study results published in prestigious NEJM Evidence
• Statistically significant improvement in PTSD symptoms (CAPS-5 scores) vs placebo
• Clinically meaningful improvements in depression and sleep measures
• FDA End-of-Phase 2 meeting completed successfully
• Phase 3 trial planned for H2 2025

Negative

• Higher rate of adverse events in BNC210 group (66.7%) vs placebo (53.8%)
• Hepatic enzyme elevations reported as common adverse event
• Phase 3 trial initiation not until H2 2025

Insights

Medical Research Analyst

The publication of Phase 2 ATTUNE study results in NEJM Evidence represents a significant milestone for BNC210 in PTSD treatment. The drug demonstrated statistically significant improvements in CAPS-5 scores (p=0.048) at Week 12, with early efficacy at Week 4. The non-psychedelic, non-sedating and non-habit-forming profile differentiates BNC210 from existing treatments. Secondary endpoints showing improvements in depression and sleep further strengthen its therapeutic potential. The safety profile appears manageable, with common side effects including headache, nausea and fatigue. With <50% of PTSD patients responding to current treatments, these results position BNC210 as a promising therapeutic candidate heading into Phase 3 trials.

Financial Analyst

This positive data publication in a prestigious journal significantly derisks Bionomics' lead asset BNC210. The company has two major catalysts ahead: the Phase 3 AFIRM-1 study results in SAD (Q3 2025) and the initiation of Phase 3 PTSD trial (H2 2025). The PTSD market represents a substantial commercial opportunity with high unmet need. The successful End-of-Phase 2 FDA meeting and planned advancement to Phase 3 indicates regulatory confidence. For a small-cap biotech (<money>$6M</money> market cap), having a late-stage CNS asset with positive Phase 2 data in two indications presents significant value creation potential.

• BNC210 improved PTSD symptom severity at Week 12 with efficacy observed as early as Week 4
• Company plans to initiate a Phase 3 study of BNC210 in PTSD in H2 2025

ADELAIDE, Australia, and CAMBRIDGE, Mass., Dec. 09, 2024 (GLOBE NEWSWIRE) -- Bionomics Limited (Nasdaq: BNOX) (Bionomics or Company), a clinical-stage biotechnology company developing novel, first-in-class, allosteric ion channel modulators to treat patients suffering from serious central nervous system (CNS) disorders with high unmet medical need, today announced that the positive results from its Phase 2 ATTUNE study have been published in the NEJM Evidence. The data were also presented yesterday at the 63ʳᵈ Annual Meeting of the American College of Neuropsychopharmacology (ACNP) as part of the inaugural “Promising Targets” session.

“We are excited to publish the results of the ATTUNE in NEJM Evidence, a prestigious journal for innovative original research. This peer-reviewed publication further validates these significant results and underscores the differentiated clinical profile of BNC210, a potential best- and first-in class treatment for PTSD that is non-psychedelic, non-sedating and non-habit-forming,” said Spyros Papapetropoulos, M.D., Ph.D., President and CEO of Bionomics. “Since our successful End-of-Phase 2 meeting with the FDA earlier this year, we have been diligently preparing for the Phase 3 study of BNC210 in PTSD which we anticipate initiating in the second half of 2025, if not sooner.”

Key results from the publication include:

• Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) total score improvement was observed with BNC210 compared with placebo (p=0.048) at Week 12 with improvement seen as early as Week 4
• Clinically meaningful and statistically significant improvements were also observed with BNC210 vs placebo in:
  • Depressive symptoms measured on the Montgomery–Åsberg Depression Rating Scale
  • Sleep measured on the Insomnia Severity Index
• Treatment-emergent adverse events (AEs) occurred in 70 (66.7%) patients in the BNC210 group and 56 (53.8%) in the placebo group. The most common AEs were headache, nausea, fatigue, and hepatic enzyme elevations.
  

“This publication highlights the encouraging and clinically meaningful improvements seen with BNC210 across several key PTSD symptoms,” commented Murray B Stein, M.D., M.P.H.; Distinguished Professor of Psychiatry and Public Health at the University of California San Diego and a senior author of the paper. “Fewer than 50% of patients experience benefit with currently approved treatments and therefore there is a pressing need for new, well-tolerated, efficacious treatments. The ATTUNE data, along with the additional clinical data of BNC210 to date, positions it as a promising potential treatment and I look forward to further seeing it assessed it in a larger Phase 3 trial.”

The Company is planning to initiate the Phase 3 trial in PTSD in the second half of 2025. BNC210 is also being evaluated in a Phase 3 AFIRM-1 study in social anxiety disorder (SAD) with anticipated readout in Q3 2025.

FOR FURTHER INFORMATION PLEASE CONTACT:

General Rajeev Chandra Company Secretary CoSec@bionomics.com.au	Investor Relations Kevin Gardner kgardner@lifesciadvisors.com	Investor Relations Chris Calabrese ccalabrese@lifesciadvisors.com

About Bionomics Limited
Bionomics (NASDAQ: BNOX) is a clinical-stage biotechnology company developing novel, potential first-in-class, allosteric ion channel modulators to treat patients suffering from serious central nervous system (CNS) disorders with high unmet medical need. Bionomics is advancing its lead drug candidate, BNC210, an oral, proprietary, selective negative allosteric modulator of the α7 nicotinic acetylcholine receptor, for the acute treatment of social anxiety disorder (SAD) and chronic treatment of post-traumatic stress disorder (PTSD). Beyond BNC210, Bionomics has a strategic partnership with Merck & Co., Inc. (known as MSD outside the United States and Canada) with two drugs in early-stage clinical trials for the treatment of cognitive deficits in Alzheimer’s disease and other CNS conditions. Bionomics’ pipeline also includes preclinical assets that target Kv3.1/3.2 and Nav1.7/1.8 ion channels being developed for CNS conditions of high unmet need.www.bionomics.com.au

Forward-Looking Statements
Bionomics cautions that statements included in this press release that are not a description of historical facts are forward-looking statements. Words such as “may,” “could,” “will,” “would,” “should,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “intend,” “predict,” “seek,” “contemplate,” “potential,” “continue” or “project” or the negative of these terms or other comparable terminology are intended to identify forward-looking statements. The forward-looking statements are based on our current beliefs and expectations and include, but are not limited to: the closing of each tranche of the Company’s private placement financing, the achievement of certain milestones for the various tranches, the timely funding to the Company by each investor in the private placement, the timing, size and expectation of the closing of the private placement; and expectations regarding market conditions, the satisfaction of customary closing conditions related to the private placement and the anticipated use of proceeds therefrom; and the Company’s expectation that its current cash, cash equivalents, and marketable securities will fund our operations into the third quarter of 2025. The inclusion of forward-looking statements should not be regarded as a representation by Bionomics that any of its plans will be achieved. Actual results may differ materially from those set forth in this release due to the risks and uncertainties inherent in the Company’s business and other risks described in the Company’s filings with the Securities and Exchange Commission (SEC), including, but not limited to, the Company’s Annual Report on Form 20-F filed with the SEC, and its other reports. Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and Bionomics undertakes no obligation to revise or update this news release to reflect events or circumstances after the date hereof. Further information regarding these and other risks, uncertainties and other factors is included in Bionomics’ filings with the SEC, copies of which are available from the SEC’s website (www.sec.gov) and on Bionomics’ website (www.bionomics.com.au) under the heading “Investor Center.” All forward-looking statements are qualified in their entirety by this cautionary statement. This caution is made under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995. Bionomics expressly disclaims all liability in respect to actions taken or not taken based on any or all the contents of this press release.

FAQ

What were the main results of Bionomics (BNOX) Phase 2 ATTUNE study for BNC210?

The study showed significant improvement in PTSD symptom severity (CAPS-5 scores) at Week 12 compared to placebo (p=0.048), with efficacy observed as early as Week 4. Additional improvements were seen in depression symptoms and sleep quality.

What are the most common side effects reported for BNC210 in the ATTUNE study?

The most common adverse events reported were headache, nausea, fatigue, and hepatic enzyme elevations, with 66.7% of patients in the BNC210 group experiencing treatment-emergent adverse events.

When will Bionomics (BNOX) start the Phase 3 trial for BNC210 in PTSD?

Bionomics plans to initiate the Phase 3 trial for BNC210 in PTSD in the second half of 2025.