SUDS

Vistagen Initiates PALISADE-3 Phase 3 Study of Fasedienol for the Acute Treatment of Social Anxiety Disorder Following Positive Results of PALISADE-2

Retrieved on: 
Monday, April 1, 2024
Mental Health, Health, Neurology, Clinical Trials, Pharmaceutical, Biotechnology, SUDS, Social anxiety disorder, Psychiatry, Patient, Anxiety, SAD, DSM-IV codes, Safety, Nursing

“Initiating PALISADE-3 is another major milestone in our plan to develop and commercialize fasedienol as the first treatment of its kind for social anxiety disorder,” said Shawn Singh, Chief Executive Officer.

Key Points: 
  • “Initiating PALISADE-3 is another major milestone in our plan to develop and commercialize fasedienol as the first treatment of its kind for social anxiety disorder,” said Shawn Singh, Chief Executive Officer.
  • The U.S. multi-center study is planned to randomize approximately 236 adults ages 18 through 65.
  • Patients will be randomized in a 1:1 ratio to fasedienol or placebo.
  • Vistagen plans to initiate PALISADE-4, which will be a replicate of PALISADE-3, during the second half of 2024.

Vistagen Reports Fiscal 2024 Third Quarter Financial Results and Provides Corporate Update

Retrieved on: 
Tuesday, February 13, 2024
Mental Health, Research, Neurology, Clinical Trials, Biotechnology, Health, Pharmaceutical, General Health, Science, Momentum, Social anxiety disorder, Anxiety, SAD, Premenstrual dysphoric disorder, Psychiatry, Safety, Menopause, SUDS, Patient, DSM-IV codes, G&A, MDD, PMDD, NDA, Hot, Pharmaceutical industry

Vistagen (Nasdaq: VTGN), a late clinical-stage biopharmaceutical company pioneering neuroscience to deliver first-in-class therapies for psychiatric and neurological disorders, today reported financial results for its fiscal year 2024 third quarter ended December 31, 2023 and provided a corporate update.

Key Points: 
  • Vistagen (Nasdaq: VTGN), a late clinical-stage biopharmaceutical company pioneering neuroscience to deliver first-in-class therapies for psychiatric and neurological disorders, today reported financial results for its fiscal year 2024 third quarter ended December 31, 2023 and provided a corporate update.
  • As of February 12, 2024, the Company had 27,029,731 shares of common stock issued and 3,577,240 pre-funded warrants outstanding.
  • Vistagen will host a conference call and live audio webcast this afternoon at 5:00 p.m. Eastern Time to provide a corporate update.
  • In addition, a telephone playback of the call will be available after approximately 8:00 p.m. Eastern Time on Tuesday, February 13, 2024.

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.

Vistagen Provides Corporate Update and Reports Fiscal 2024 Second Quarter Financial Results

Retrieved on: 
Thursday, November 9, 2023
Biotechnology, Mental Health, Health, Pharmaceutical, Clinical Trials, NDA, CNS, Depression, Safety, PMDD, Hot, Food, Menstrual cycle, DSM-IV codes, PALISADE, Alnylam Pharmaceuticals, Initiate, Menopause, Social anxiety disorder, SAD, Clinical trial, Optimism, Patient, Research, Premenstrual dysphoric disorder, FDA, SUDS, Panic, Anxiety, R, Fasedienol, Central nervous system, MDD, Pharmaceutical industry, Sales, Broadcasting

Vistagen (Nasdaq: VTGN), a late clinical-stage biopharmaceutical company aiming to transform the treatment landscape for individuals living with anxiety, depression, and other central nervous system (CNS) disorders, today provided a corporate update and reported financial results for its fiscal year 2024 second quarter ended September 30, 2023.

Key Points: 
  • Vistagen (Nasdaq: VTGN), a late clinical-stage biopharmaceutical company aiming to transform the treatment landscape for individuals living with anxiety, depression, and other central nervous system (CNS) disorders, today provided a corporate update and reported financial results for its fiscal year 2024 second quarter ended September 30, 2023.
  • To complement the positive top-line results from PALISADE-2, the Company is preparing to launch two similar Phase 3 clinical trials in 2024, PALISADE-3 in the first half of 2024 and PALISADE-4 in the second half of 2024.
  • She joins Vistagen from Alnylam Pharmaceuticals where she served as the Chief Accounting Officer, focused on strategic and financial operations.
  • Vistagen will host a conference call and live audio webcast this afternoon at 5:00 p.m. Eastern Time to provide a corporate update.

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

Retrieved on: 
Tuesday, November 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

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.

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

Retrieved on: 
Thursday, August 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.

Vistagen Announces Positive Top-Line Results from Phase 3 PALISADE-2 Trial of Fasedienol (PH94B) Nasal Spray in Social Anxiety Disorder

Retrieved on: 
Monday, August 7, 2023
Biotechnology, Mental Health, Health, Pharmaceutical, Clinical Trials, Columbia University, Depression, Central nervous system, Liebowitz social anxiety scale, Anxiety, Aes, SAD, Medicine, CNS, New York State Psychiatric Institute, Visit, Patient, LSAS, Anxiety disorder, Social anxiety disorder, PH94B, Social anxiety, Fasedienol, Safety, Pharmaceutical industry, Nursing, Medical imaging, SUDS

The trial met its primary endpoint, with fasedienol demonstrating a statistically significant difference in average SUDS score during a public speaking challenge compared to placebo (p=0.015).

Key Points: 
  • The trial met its primary endpoint, with fasedienol demonstrating a statistically significant difference in average SUDS score during a public speaking challenge compared to placebo (p=0.015).
  • The trial also met its secondary endpoint, demonstrating a statistically significant difference in the proportion of clinician-assessed responders between fasedienol and placebo as measured by the CGI-I scale (p=0.033).
  • Fasedienol was well-tolerated and demonstrated a favorable safety profile consistent with all prior trials.
  • “As a new class of medicines, our pherine nasal spray pipeline holds the potential to transform the treatment landscape across numerous therapeutic areas.

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

Retrieved on: 
Thursday, March 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

Retrieved on: 
Thursday, February 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.