Subjective units of distress scale

Vistagen to Present Positive Fasedienol Phase 3 Data and Positive PH80 Phase 2A Data at Upcoming Scientific Conferences

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화요일, 11월 7, 2023
Mental Health, Health, Neurology, Clinical Trials, Pharmaceutical, Biotechnology, Subjective units of distress scale, Hot, Depression, Anxiety, Social anxiety disorder, Patient, Fasedienol, CNS, SAD, SUDS, Central nervous system, Pharmaceutical industry, Nursing

“Vistagen’s presentations highlight the significant progress we have made to advance new therapies to address urgent unmet patient needs,” said Shawn Singh, Chief Executive Officer of Vistagen.

Key Points: 
  • “Vistagen’s presentations highlight the significant progress we have made to advance new therapies to address urgent unmet patient needs,” said Shawn Singh, Chief Executive Officer of Vistagen.
  • Fasedienol data demonstrating long-term, open-label treatment from nearly 500 patients was safe and well-tolerated and provided improved overall symptom control in adults with SAD.
  • PH80 data demonstrating statistically significant reduction in the number of hot flashes compared to placebo (p<.001 after="" four="" weeks="" of="" treatment="" in="" women="" diagnosed="" with="" vasomotor="" symptoms="" flashes="" due="" to="" menopause.="">
  • Title: A Phase 2A Clinical Study to Investigate the Efficacy, Safety, and Tolerability of PH80 for the Acute Management of Menopausal Vasomotor Symptoms (Hot Flashes) in Women

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

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월요일, 10월 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.

Subsequent to the Release of Positive Phase 3 Trial Results, Vistagen Provides Corporate Update and Reports Fiscal 2024 First Quarter Financial Results

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목요일, 8월 10, 2023
Biotechnology, Mental Health, Health, Pharmaceutical, Clinical Trials, Neuron, Hot, Optimism, Central nervous system, Depression, Nasal cavity, Anxiety, Aes, New Drug Application, Food and Drug Administration, Calendar, Clinical Global Impression, NDA, Woman, Subjective units of distress scale, SAD, Liebowitz social anxiety scale, Multimedia, Brain, CNS, Trial of the century, Visit, PALISADE, MDD, Patient, LSAS, Menopause, Social anxiety disorder, FDA, Fasedienol, Safety, Pharmaceutical industry, Nursing, Medical imaging, Dietary supplement, SUDS

Phase 3 study of an investigational therapy for social anxiety disorder in over 15 years,” said Shawn Singh, Chief Executive Officer of Vistagen.

Key Points: 
  • Phase 3 study of an investigational therapy for social anxiety disorder in over 15 years,” said Shawn Singh, Chief Executive Officer of Vistagen.
  • Positive Phase 3 PALISADE-2 study of fasedienol yields statistically significant top-line results for the acute treatment of anxiety in adults with SAD.
  • Based on the positive top-line results of the Phase 3 PALISADE-2 study, we are currently preparing for our Phase 3 PALISADE-3 trial, with potential to initiate the trial during the first half of calendar 2024.
  • Vistagen will host a conference call and live audio webcast this afternoon at 4:30 p.m. Eastern Time to provide a corporate update.

Bionomics Reports Promising Full Results Analysis from PREVAIL Phase 2 Study of BNC210 Social Anxiety Disorder (SAD)

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목요일, 3월 9, 2023
Subjective units of distress scale, BNO, Clutch (eggs), Anxiety, Patient, FDA, SUDS, Central nervous system, Social anxiety disorder, Benzodiazepine, SAD, STAI, Data, Doctor of Philosophy, CNS, MPH, BNC210, Safety, Pharmaceutical industry, MD, Bionomics, Webcast

While PREVAIL did not meet its primary endpoint, the December 2022 topline data readout revealed encouraging trends in the prespecified endpoints that focused on individual phases of the public speaking task.

Key Points: 
  • While PREVAIL did not meet its primary endpoint, the December 2022 topline data readout revealed encouraging trends in the prespecified endpoints that focused on individual phases of the public speaking task.
  • These results supported a post-hoc in-depth analysis of the full dataset to better understand the true potential of the drug and guide late-stage trial design.
  • Converging trends favouring BNC210 were also observed in the State-Trait Anxiety Inventory (STAI).
  • In addition to the favourable efficacy, the overall safety profile of BNC210 was found to be consistent with a non-sedating anxiolytic.

Bionomics’ Half-Year Report

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목요일, 2월 23, 2023
MSD, Safety, American depositary receipt, Post-traumatic stress disorder, SUDS, BNC210, Deficit spending, Subjective units of distress scale, Merck, Social anxiety disorder, Bionomics, ASX, PAMS, Partnership, SAD, Merck & Co., United Kingdom, Research, Patient, PTSD, MDMA, CNS, Non-executive director, Public, BNO, ADS, Data, Pharmaceutical industry

ADELAIDE, Australia, Feb. 23, 2023 (GLOBE NEWSWIRE) -- Bionomics Limited (ASX: BNO, NASDAQ: BNOX), today announced its FY2023 report for the half-year ended 31 December 2022.

Key Points: 
  • ADELAIDE, Australia, Feb. 23, 2023 (GLOBE NEWSWIRE) -- Bionomics Limited (ASX: BNO, NASDAQ: BNOX), today announced its FY2023 report for the half-year ended 31 December 2022.
  • The Company recently completed its Phase 2 PREVAIL Study to evaluate BNC210 for the acute treatment of Social Anxiety Disorder (SAD).
  • The PREVAIL Study completed recruitment, and topline data were reported on 19 December 2022.
  • The Company is continuing its analysis of the PREVAIL dataset and is assessing the next steps for the development of BNC210 in SAD.

Quarterly Activities and Cashflow Report

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월요일, 1월 30, 2023
Australian Government, Credit, Corporate governance, ASX, PTSD, Bionomics, Non-executive director, Quarter, ADS, BNC210, Evercore, Credit Suisse, Subjective units of distress scale, Executive, Research, Public, CNS, Mass meeting, Evaluation, Conference, SUDS, ACDT, Annual general meeting, BNO, Fireside chats, Social anxiety disorder, Proportionality (law), United Kingdom, Contract research organization, Fireside, Allosteric regulation, KOL, Data, Social anxiety, American College, Safety, GABAA receptor negative allosteric modulator, Central nervous system, Patient, SAD, Annual report, Pharmaceutical industry, Renewable energy, Health insurance, Animal, Management, MD

Annual Report on Form 20-F with the U.S. Securities and Exchange Commission for the financial year ended 30 June 2022.

Key Points: 
  • Annual Report on Form 20-F with the U.S. Securities and Exchange Commission for the financial year ended 30 June 2022.
  • On 25 October 2022, Bionomics released the Quarterly Activities Report for the quarter ending September 2022.
  • Finally, with the additional financing activities during the quarter, the Company has sufficient cash runway to support its ongoing activities and upcoming milestones with runway to at least mid-2024.
  • 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 Reports Topline Results in PREVAIL Phase 2 Study of BNC210 in Social Anxiety Disorder

Retrieved on: 
월요일, 12월 19, 2022
Life, Data, CNS, Fear, Safety, Rest, Subjective units of distress scale, Social anxiety disorder, SUDS, Central nervous system, Public, BNO, SAD, PTSD, STAI, BNC210, Liebowitz social anxiety scale, Self-assessment, Coffee, Patient, Anxiety, Pharmaceutical industry, Bionomics, MD

BNC210 has a novel mechanism of action that involves negative allosteric modulation of the α7 nicotinic acetylcholine receptor.

Key Points: 
  • BNC210 has a novel mechanism of action that involves negative allosteric modulation of the α7 nicotinic acetylcholine receptor.
  • The Company is continuing analysis of the PREVAIL dataset and is assessing next steps for the development of BNC210 in SAD.
  • Secondary outcome measures included self-assessment with the State-Trait Anxiety Inventory (STAI), a commonly used measure of trait and state anxiety, and an assessment with the Negative Self-Statements During Public Speaking subscale (SSPS-N).
  • SAD is a significant and persistent fear of social and performance-related situations.

VistaGen Therapeutics Reports First Quarter Financial Results and Provides Corporate Update

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목요일, 8월 11, 2022
Mental Health, Health, Neurology, Clinical Trials, Pharmaceutical, Biotechnology, FDA, U.S. Securities and Exchange Commission, Social anxiety disorder, MDD, Depression, Lists of diseases, Liebowitz social anxiety scale, Probenecid, Subjective units of distress scale, NDA, SUDS, Industry, CNS, Trial of the century, R, PH10, Neuron, Major depressive disorder, SEC, Brain, IND, Social anxiety, Anxiety, Research, Annual report, LSAS, Adjustment disorder, Patient, Therapy, SAD, COVID-19, Company, State, Calendar, Central nervous system disease, Central nervous system, PH94B, Safety, PIN, Risk, Investigational New Drug, Nasdaq, Time, NMDA, PALISADE, Pharmaceutical industry, Fine chemical, G&A, Ajda

Our mission is to transform lives, and we have a strong pipeline and team in place to accomplish that goal, added Singh.

Key Points: 
  • Our mission is to transform lives, and we have a strong pipeline and team in place to accomplish that goal, added Singh.
  • VistaGen will host a conference call and live audio webcast this afternoon at 5:00 p.m. Eastern Time to provide a corporate update and discuss its financial results for its first quarter fiscal year 2023 ended June 30, 2022.
  • VistaGen is passionate about transforming mental health care and redefining what is possible in the treatment of anxiety and depression.
  • The Company explicitly disclaims any obligation to update any forward-looking statements, other than as may be required by law.

VistaGen Announces Topline Results from PALISADE-1 Phase 3 Clinical Trial for Investigational Drug PH94B

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금요일, 7월 22, 2022
Health, Pharmaceutical, Fear, Anxiety, Industry, U.S. Securities and Exchange Commission, Social anxiety disorder, Subjective units of distress scale, SEC, Risk, SAD, PH94B, CNS, Therapy, Adult, Safety, COVID-19, Benzodiazepine, Glycine, Quality of life, Central nervous system, Panic disorder, FDA, Company, SUDS, Patient, Nasdaq, Post-traumatic stress disorder, NMDAR, Depression, Annual report, PH10, Central nervous system disease, Employment, Lists of diseases, Pharmaceutical industry

Although the trial did not meet its primary endpoint, the tolerability profile of PH94B in PALISADE-1 was favorable and consistent with previously reported results from all other clinical trials.

Key Points: 
  • Although the trial did not meet its primary endpoint, the tolerability profile of PH94B in PALISADE-1 was favorable and consistent with previously reported results from all other clinical trials.
  • No severe or serious adverse events were reported for PH94B in prior clinical trials or in PALISADE-1.
  • PALISADE-1 was a multi-center, randomized, double-blind, placebo-controlled, parallel design, Phase 3 clinical study in adults diagnosed with social anxiety disorder (SAD).
  • Prior to the public speaking challenge, the subjects were randomized to receive a single dose of PH94B or placebo.

VistaGen Announces Completion of PALISADE-1 Phase 3 Clinical Study of PH94B for the Acute Treatment of Social Anxiety Disorder

Retrieved on: 
수요일, 6월 22, 2022
Biotechnology, Mental Health, Health, Pharmaceutical, Clinical Trials, CNS, Industry, FDA, NDA, Social anxiety disorder, Therapy, Risk, COVID-19, Fear, PH94B, Safety, Neuron, Anxiety, Annual report, Subjective units of distress scale, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Panic disorder, Central nervous system disease, Benzodiazepine, Company, Brain, SUDS, U.S. Securities and Exchange Commission, Depression, Trial of the century, Fast Track, PTSD, PH10, Central nervous system, Post-traumatic stress disorder, Marketing, PALISADE, Quality of life, SAD, Screen for child anxiety related disorders, SEC, Nasdaq, MOA, Adult, Food, Patient, Employment, Principal, Pharmaceutical industry

VistaGens PALISADE-1 Phase 3 clinical trial is a U.S. multi-center, randomized, double-blind, placebo-controlled, parallel design, clinical study in adults diagnosed with SAD.

Key Points: 
  • VistaGens PALISADE-1 Phase 3 clinical trial is a U.S. multi-center, randomized, double-blind, placebo-controlled, parallel design, clinical study in adults diagnosed with SAD.
  • VistaGens PALISADE Phase 3 Program in social anxiety disorder (SAD) is designed to further demonstrate the potential of PH94B as a fast-acting, acute treatment of anxiety in adults with SAD.
  • Based on positive Phase 2 data in social anxiety disorder (SAD) patients, VistaGen is currently evaluating PH94B in two Phase 3 clinical studies in the U.S., PALISADE-1 and PALISADE-2, for the acute treatment of anxiety in adults with SAD.
  • Should ongoing Phase 3 studies be successful, PH94B has the potential to be the first FDA-approved, fast-acting, acute treatment of anxiety for adults with social anxiety disorder.