Associated tags: MSD, BNC210, Post-traumatic stress disorder, Central nervous system, Deficit spending, Merck & Co., ASX, Merck, Bionomics, Patient, BNO, Social anxiety disorder, Pharmaceutical industry, CNS, SAD, PTSD
Locations: FLORIDA, USA, UK, CAMBRIDGE, MA, US, NEW YORK, NY, AUSTRALIA, CANADA, UNITED STATES
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.
Retrieved on:
Thursday, February 22, 2024
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:
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.
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.
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.
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.
Retrieved on:
Friday, September 29, 2023
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Retrieved on:
Thursday, September 28, 2023
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Central nervous system,
University,
BNC210,
Week,
SDS,
Sleep,
Liver,
EST,
University of California, San Diego Performance-Based Skills Assessment,
CNS,
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Public health,
Patient,
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Grammatical mood,
Psychiatry,
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Social anxiety disorder,
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United Kingdom,
DSM-5,
FDA,
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Regulation of food and dietary supplements by the U.S. Food and Drug Administration,
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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.
Retrieved on:
Thursday, September 14, 2023
MSD,
GABAA receptor positive allosteric modulator,
Ion channel,
Human,
Society,
Central nervous system,
PAM,
Royal Society of Chemistry,
Pharmacokinetics,
Research,
RSC,
Society of Chemical Industry,
Patient,
Chemical industry,
DSM-IV codes,
Acetylcholine,
Merck,
Merck & Co.,
SCI,
PAMS,
BioScience Research Collaborative,
Pharmaceutical industry,
Bionomics MSD has subsequently developed MK-4334, a novel clinical candidate, which in early preclinical studies has shown improved drug like and pharmacological properties relative to BNC375.
Key Points:
- MSD has subsequently developed MK-4334, a novel clinical candidate, which in early preclinical studies has shown improved drug like and pharmacological properties relative to BNC375.
- Under the 2014 exclusive Research Collaboration and License Agreement, MSD funds all research and clinical development, and worldwide commercialization of any resulting products.
- This collaboration generated payments of $20M upfront and $10M for a Phase 1 milestone.
- Bionomics is eligible to receive up to $465M in additional milestone payments for certain development and commercial milestones plus royalties on net sales of licensed drugs.
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’.
