BNC210

Bionomics Reports Results of the Full Dataset Analysis from ATTUNE Phase 2b Trial of BNC210 in Patients with Post-Traumatic Stress Disorder

Retrieved on: 
Thursday, March 21, 2024
Week, Selective serotonin reuptake inhibitor, Data analysis, Post-traumatic stress disorder, Central nervous system, Patient, CNS, BNC210, Safety, DSM-5, FDA, PTSD, Pharmaceutical industry

ADELAIDE, Australia and CAMBRIDGE, Mass., March 21, 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 the release of the full dataset analysis from its Phase 2b ATTUNE trial in patients with post-traumatic stress disorder.

Key Points: 
  • In September 2023, Bionomics reported the topline results for the Phase 2b ATTUNE trial of BNC210 in patients with PTSD demonstrating that the trial met its primary endpoint and several secondary endpoints, and that BNC210 was generally well tolerated.
  • The full data analysis is detailed below and in an accompanying presentation of the results that is posted on the Company’s website .
  • “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.
  • 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.

Bionomics to Present at the 2024 BIO CEO & Investor Conference

Retrieved on: 
Thursday, February 22, 2024
Social anxiety disorder, Central nervous system, Bionomics, BIO, Conference, CNS, Patient, BNC210

ADELAIDE, Australia and CAMBRIDGE, Mass., Feb. 22, 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 it will be presenting at the 2024 BIO CEO & Investor Conference taking place February 26-27, 2024 in New York, NY.

Key Points: 
  • ADELAIDE, Australia and CAMBRIDGE, Mass., Feb. 22, 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 it will be presenting at the 2024 BIO CEO & Investor Conference taking place February 26-27, 2024 in New York, NY.
  • Spyros Papapetropoulos, M.D., Ph.D., President and CEO of Bionomics will be providing an update on the Company’s leading asset, BNC210, a Phase 3 ready, first- and best-in-class α7 nicotinic receptor negative allosteric modulator in development for the treatment of social anxiety disorder and post-traumatic stress disorder.
  • For those interested in meeting Bionomics’ management during the conference, please request a meeting through the conference portal or contact the Company’s Investor Relations.
  • FOR FURTHER INFORMATION PLEASE CONTACT:

Bionomics Provides a Review of 2023 and of 2024 Plans

Retrieved on: 
Monday, January 22, 2024
MSD, Schizophrenia, BNC210, Deficit spending, Patient, Module (mathematics), PAMS, PTSD, Post-traumatic stress disorder, Sleep, Partnership, Merck & Co., GAD, NAM, Anxiety, Neuropsychiatry, SAD, Alzheimer's disease, Central nervous system, Australian Securities Exchange, FDA, DSM-IV codes, CIAS, Breakthrough therapy, Panic, Merck, Phase, Data analysis, Data, CNS, Social anxiety disorder, Pharmaceutical industry

ADELAIDE, Australia and CAMBRIDGE, Mass., Jan. 22, 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 provided a 2023 review and its outlook for 2024.

Key Points: 
  • ADELAIDE, Australia and CAMBRIDGE, Mass., Jan. 22, 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 provided a 2023 review and its outlook for 2024.
  • “Bionomics continued its evolution into a U.S.-focused, late-stage clinical company last year.
  • Voluntarily delisted from the Australian Stock Exchange in August 2023 and is currently solely listed on the NASDAQ Global Market.
  • Bionomics continues to plan the initiation of its first Phase 3 study of BNC210 in patients with SAD.

Bionomics to Present at Biotech Showcase™ 2024

Retrieved on: 
Friday, January 5, 2024
Biotechnology, BNC210, Social anxiety disorder, Bionomics, CNS, JPMorgan Chase, Central nervous system, Patient

ADELAIDE, Australia and CAMBRIDGE, Mass., Jan. 05, 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 it will be presenting at the Biotech Showcase™ 2024 taking place January 8-10 in San Francisco, California.

Key Points: 
  • ADELAIDE, Australia and CAMBRIDGE, Mass., Jan. 05, 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 it will be presenting at the Biotech Showcase™ 2024 taking place January 8-10 in San Francisco, California.
  • Spyros Papapetropoulos, M.D., Ph.D., President and CEO of Bionomics will be providing an update on the Company’s leading asset, BNC210, a Phase 3 ready α7 nicotinic receptor negative allosteric modulator with the potential to be first- and best-in-class in social anxiety disorder and post-traumatic stress disorder.
  • Location: Hilton San Francisco – Union Square, Yosemite A
    Company’s management will be available for one-on-one meetings with registered investors and potential partners.
  • In addition, Bionomics will host one-on-one meetings in San Francisco during JP Morgan week.

Bionomics Presents Detailed Data on the Validity and Reliability of the Subjective Units of Distress Scale at the 2023 American College of Neuropsychopharmacology Annual Meeting

Retrieved on: 
Wednesday, December 6, 2023
Food, FDA, BNC210, Social anxiety disorder, Anxiety, STAI, CNS, SAD, American College, Central nervous system, Patient, SUDS, Social anxiety, State-Trait Anxiety Inventory, Nursing

A psychometric analysis concluded that Subjective Units of Distress Scale (SUDS) is a psychometrically valid, sensitive, and reliable tool for evaluation of social anxiety.

Key Points: 
  • A psychometric analysis concluded that Subjective Units of Distress Scale (SUDS) is a psychometrically valid, sensitive, and reliable tool for evaluation of social anxiety.
  • SUDS will be used as the primary outcome in future Phase 3 social anxiety disorder (SAD) clinical trials.
  • Reliability: The reliability of the SUDS at 20- and 30-minutes post-challenge was very high for both the placebo and the full population.
  • Validity: Baseline SUDS scores demonstrated good convergent validity when compared with State-Trait Anxiety Inventory (STAI) scores.

Bionomics Announces Successful End-of-Phase 2 Meeting with the FDA and Solidifies Plans to Initiate the Registrational Program for BNC210 in Social Anxiety Disorder

Retrieved on: 
Monday, October 16, 2023
Generalized anxiety disorder, Food, SUDS, BNC210, Subjective units of distress scale, Central nervous system, Data, FOR, FDA, SAD, Food and Drug Administration, NDA, Regulation of tobacco by the U.S. Food and Drug Administration, Social anxiety disorder, Element, Clutch (eggs), Post-traumatic stress disorder, CNS, Patient, Pharmaceutical industry, Surveying, Bionomics

“We are grateful for FDA’s support and guidance and very pleased to reach an agreement on key elements of Phase 3 design and other nonclinical components required for registration”, said Spyros Papapetropoulos, M.D., Ph.D., President and CEO of Bionomics.

Key Points: 
  • “We are grateful for FDA’s support and guidance and very pleased to reach an agreement on key elements of Phase 3 design and other nonclinical components required for registration”, said Spyros Papapetropoulos, M.D., Ph.D., President and CEO of Bionomics.
  • “The FDA meeting outcomes provide external and independent validation of our position on the strength and Phase 3-enabling nature of the PREVAIL dataset.
  • BNC210’s unique clinical profile seen in multiple anxiety disorders including SAD, Generalized Anxiety Disorder and in a panic model, was recently significantly enhanced by the positive results in Post-Traumatic Stress Disorder.
  • The Company anticipates beginning the Phase 3 program in Q1’24.

Bionomics Announces Positive Topline Results from the Phase 2b ATTUNE Clinical Trial of BNC210 in Patients with Post-Traumatic Stress Disorder (PTSD)

Retrieved on: 
Thursday, September 28, 2023
ISI, Central nervous system, University, BNC210, Week, SDS, Sleep, Liver, EST, University of California, San Diego Performance-Based Skills Assessment, CNS, MADRS, Public health, Patient, Data, Grammatical mood, Psychiatry, Insomnia, Social anxiety disorder, Nausea, United Kingdom, DSM-5, FDA, Headache, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Food, Fatigue, Medical imaging, Pharmaceutical industry, Bionomics, PTSD

Company plans to engage with the U.S. Food and Drug Administration (FDA) to discuss the registrational path for BNC210 in PTSD.

Key Points: 
  • Company plans to engage with the U.S. Food and Drug Administration (FDA) to discuss the registrational path for BNC210 in PTSD.
  • “We are excited about the results of the ATTUNE trial that delivered a positive dataset with treatment effects considerably higher than currently approved therapies.
  • Despite the clinical heterogeneity of PTSD, the results of ATTUNE demonstrated broad benefits with BNC210 across a number of symptoms.
  • The company will discuss the topline ATTUNE study results on the webcast today at 8:00am EST and is planning to advance BNC210 for the treatment of PTSD into registrational studies.

Bionomics Completes Last Patient Last Visit in the Phase 2b ATTUNE Study for Post-Traumatic Stress Disorder (PTSD) and Confirms Expected 2023 Milestones with its Lead Asset BNC210

Retrieved on: 
Wednesday, August 23, 2023
Clinician Administered PTSD Scale, ISI, Central nervous system, Depression, BNC210, Official List, FOR, Montgomery–Åsberg Depression Rating Scale, Anxiety, SDS, Sleep, BNO, SAD, Australian Securities Exchange, DSM-IV codes, Hamilton Anxiety Rating Scale, Phase 3, Patient, Insomnia, Social anxiety disorder, United Kingdom, PGI, CGI, DSM-5, FDA, Regulation of tobacco by the U.S. Food and Drug Administration, Food, Pharmaceutical industry, Bionomics, PTSD

“I would like to thank study participants, their families, our clinical site investigators and their staff and our clinical team for their contributions towards achieving completion of the ATTUNE study.

Key Points: 
  • “I would like to thank study participants, their families, our clinical site investigators and their staff and our clinical team for their contributions towards achieving completion of the ATTUNE study.
  • The EoPh2 meeting to discuss advancing BNC210 into Phase 3 development as an acute treatment for SAD has been scheduled for mid-September 2023.
  • Additionally, Bionomics is scheduled to delist from the Official List of the Australian Securities Exchange on 28 August 2023.
  • The Company will remain an Australian incorporated company and will maintain its listing of ADSs on Nasdaq under the trading symbol ‘BNOX’.

Quarterly Activities and Cashflow Report

Retrieved on: 
Monday, July 31, 2023
Psychopharmacology, Regulation of tobacco by the U.S. Food and Drug Administration, Employment, Central nervous system, BNC210, Quarter, Post-traumatic stress disorder, Comptroller, Audit, American depositary receipt, Delisting, F-3, Educational Strategy for Developing Societies, BNO, ASX, SAD, Research, Bionomics, CNS, Sale, Development, ATM, Prospectus, Patient, Form, CFO, FDA, Society, Conference, Food, PTSD, Pharmaceutical industry, Security (finance), Cryptocurrency, Management, Online shopping, Cantor

On 28 April 2023, Bionomics released its Appendix 4C – Quarterly Cashflow Report for the quarter ended 31 March 2023.

Key Points: 
  • On 28 April 2023, Bionomics released its Appendix 4C – Quarterly Cashflow Report for the quarter ended 31 March 2023.
  • Bionomics may determine to sell some, all, or none of the ADSs under the ATM Program and may terminate the ATM Program at its discretion.
  • Start-up activities for a planned Phase 3 trial of BNC210 in SAD are underway.
  • A copy of the full release, including a copy of the ASX Appendix 4C Cashflow Report can be found on the Company's website.

Bionomics Announces Intention to Delist from the Australian Securities Exchange (ASX)

Retrieved on: 
Tuesday, July 25, 2023
Central nervous system, BNC210, American depositary receipt, ASX, BNO, SAD, Australian Securities Exchange, Bionomics, CNS, Patient, Social anxiety disorder, PTSD, Acute stress disorder

“Bionomics is approaching several very important value-inflection milestones for our late-stage clinical development program with BNC210, a first and best-in class α7 nicotinic receptor negative allosteric modulator under evaluation in patients with Social Anxiety Disorder (SAD) and Post-Traumatic Stress Syndrome (PTSD), in the coming quarters,” said Spyros Papapetropoulos, M.D.

Key Points: 
  • “Bionomics is approaching several very important value-inflection milestones for our late-stage clinical development program with BNC210, a first and best-in class α7 nicotinic receptor negative allosteric modulator under evaluation in patients with Social Anxiety Disorder (SAD) and Post-Traumatic Stress Syndrome (PTSD), in the coming quarters,” said Spyros Papapetropoulos, M.D.
  • Ph.D., Bionomics’ President and CEO; “As we continue our transformation to a U.S.-focused organization, we would like to deepen our engagement with the broadest range of potential investors and maximize Bionomics’ access to capital and financing opportunities while reducing costs and compliance obligations associated with a dual listing.
  • All information will be made available at https://ir.bionomics.com.au/ .
  • FOR FURTHER INFORMATION PLEASE CONTACT: