Social anxiety disorder

atai Life Sciences Company GABA Therapeutics Announces Positive Final Results from Phase 1 Single and Multiple Ascending Dose Trial of GRX-917

Retrieved on: 
Monday, January 9, 2023
World Health Organization, Neuropsychiatric Disease and Treatment, Therapy, Quantitative electroencephalography, Lorazepam, GABA, Antidepressant discontinuation syndrome, Social anxiety disorder, Panic disorder, Mental health, Safety, SAD, MD, GAD, Central nervous system, Alprazolam, Anxiety, MAD, CMO, Doctor of Philosophy, Benzodiazepine, Hypoventilation, Vaccine, Medical imaging, Pharmaceutical industry

GRX-917 was well tolerated with sedation comparable to placebo noted over the entirety of the dose range explored.

Key Points: 
  • GRX-917 was well tolerated with sedation comparable to placebo noted over the entirety of the dose range explored.
  • Initiation of a GRX-917 efficacy study is anticipated in H1 2023 with results expected in 2024.
  • NEW YORK and BERLIN, Jan. 09, 2023 (GLOBE NEWSWIRE) -- Today, atai Life Sciences N.V. (Nasdaq: ATAI) (“atai” or “the Company”), a clinical-stage biopharmaceutical company aiming to transform the treatment of mental health disorders, and its subsidiary GABA Therapeutics, announced final positive results from a Phase 1 clinical trial of GRX-917 that were previously announced as preliminary results during atai’s R&D day.
  • The randomized, double-blind, placebo-controlled trial was designed to evaluate the safety, tolerability, and pharmacokinetic profile of single and multiple ascending doses of orally administered GRX-917.

Vistagen Advances Intellectual Property Program to Expand Patent Protection for PH94B to Include Treatment of Adjustment Disorder

Retrieved on: 
Friday, December 30, 2022
Biotechnology, Pharmaceutical, Health, Mental Health, Migraine, Anxiety, SAD, Flash, Central nervous system, Facilitated diffusion, MDD, PH94B, Patent, Depression, CNS, Acquisition, Ajda, Cognition, Social anxiety disorder, PH10, Pharmaceutical industry

These new filings are intended to provide a global exclusivity platform for PH94B in AjD, similar to the Company’s patent protection for PH94B for the treatment of social anxiety disorder (SAD), and for its other late-clinical stage product candidate, PH10, for the treatment of major depressive disorder (MDD).

Key Points: 
  • These new filings are intended to provide a global exclusivity platform for PH94B in AjD, similar to the Company’s patent protection for PH94B for the treatment of social anxiety disorder (SAD), and for its other late-clinical stage product candidate, PH10, for the treatment of major depressive disorder (MDD).
  • Vistagen recently announced its pending acquisition of Pherin Pharmaceuticals, Inc.
  • Vistagen will also gain full ownership of three new early clinical-stage pherine product candidates: PH15 for cognition improvement; PH284 for appetite-related disorders and PH80 for migraine and hot flashes.
  • When the acquisition is completed, Vistagen's global patent portfolio for novel pherine class compounds will further expand to include U.S. and foreign counterpart patent applications related to the use of PH80 for the treatment of migraine and for the treatment of hot flashes.

Vistagen to Acquire Pherin Pharmaceuticals

Retrieved on: 
Wednesday, December 21, 2022
Biotechnology, Neurology, Health, Pharmaceutical, Clinical Trials, Migraine, Anxiety, SAD, Flash, Disorder, Central nervous system, MDD, PH94B, Depression, CNS, Acquisition, Patient, Ajda, Cognition, Social anxiety disorder, PH10, Pharmaceutical industry, Pherine

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, and Pherin Pharmaceuticals, Inc., a clinical-stage drug development company focused on the discovery and development of investigational pherine compounds for treatment of neuropsychiatric and neuroendocrine conditions (Pherin), today announced that the companies have entered into a definitive agreement under which Vistagen will acquire Pherin for approximately 12.4 million shares of Vistagen common stock and a nominal amount of cash.

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, and Pherin Pharmaceuticals, Inc., a clinical-stage drug development company focused on the discovery and development of investigational pherine compounds for treatment of neuropsychiatric and neuroendocrine conditions (Pherin), today announced that the companies have entered into a definitive agreement under which Vistagen will acquire Pherin for approximately 12.4 million shares of Vistagen common stock and a nominal amount of cash.
  • Upon closing of the acquisition, which is subject to certain customary closing conditions, Vistagen will acquire Pherin’s entire pherine pipeline, resulting in Vistagen gaining full ownership of intellectual property rights to its two most advanced drug candidates, PH94B, currently in Phase 3 development for social anxiety disorder (SAD) and Phase 2 development for adjustment disorder with anxiety (AjDA), and PH10, in clinical development for major depressive disorder (MDD).
  • Vistagen will also expand its pipeline with three new early clinical-stage pherine product candidates: PH15 for cognition improvement; PH80 for migraine and hot flashes; and PH284 for appetite-related disorders.
  • “Since 2018, we have observed the experienced Vistagen team working diligently to advance all aspects of development for PH94B and PH10.

Bionomics Reports Topline Results in PREVAIL Phase 2 Study of BNC210 in Social Anxiety Disorder

Retrieved on: 
Monday, December 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.

Bionomics appoints Spyridon “Spyros” Papapetropoulos as President and Chief Executive Officer

Retrieved on: 
Thursday, December 15, 2022
Biogen, Corporations Act 2001, Psychiatry, Social anxiety disorder, Employment, Michele Cavion, CNS, ASX, Extraordinary general meeting, School, Public sector, Faculty, EVP, Central nervous system disease, Central nervous system, Vigil, Doctor of Philosophy, Neurology, BNO, Pfizer, SVP, EGM, MD, Neurodegeneration, Corporation, BNC210, Non-executive director, Hotel des Indes (The Hague), Allergan, Appendix (anatomy), Post-traumatic stress disorder, Therapy, FOR, University, Development, Patient, Pharmaceutical industry, Security (finance), Bionomics, Appendix

as President and Chief Executive Officer (CEO), effective 5 January 2023.

Key Points: 
  • as President and Chief Executive Officer (CEO), effective 5 January 2023.
  • Spyros is an experienced biopharmaceutical executive, a recognized neuroscientist/neurologist, and change agent with a 25-year career focused on CNS disorders.
  • Prior to joining Vigil, he served as Chief Development Officer, and SVP, Head of Development at Acadia Pharmaceuticals Inc., CEO at SwanBio Therapeutics, and EVP of Research & Development and Chief Medical Officer at Cavion.
  • The additional options are part of the compensation of Dr. De Souza for his period as Executive Chair of Bionomics.

Bionomics Announces Accepted Abstract and Upcoming Poster Presentations at the American College of Neuropsychopharmacology (ACNP) 2022 Annual Meeting

Retrieved on: 
Friday, December 2, 2022
Social anxiety disorder, American College of Neuropsychopharmacology, FOR, GABAA receptor negative allosteric modulator, Central nervous system, CNS, Proportionality (law), BNO, Evaluation, Bionomics, Patient, SAD, American College, Allosteric regulation, PTSD, BNC210, Pharmaceutical industry

ADELAIDE, Australia, Dec. 02, 2022 (GLOBE NEWSWIRE) -- Bionomics Limited (Nasdaq: BNOX | ASX: BNO) (Bionomics or Company), a clinical-stage biopharmaceutical company developing novel, allosteric ion channel modulators designed to transform the lives of patients suffering from serious central nervous system (CNS) disorders, today announced it will present data on the development of an oral tablet formulation of BNC210 for the treatment of Social Anxiety Disorder (SAD) and data on the pharmacometrics analysis and drug reformulation of BNC210 for the treatment of PTSD at the 61st Annual meeting of the American College of Neuropsychopharmacology (ACNP) to be held in-person Sunday through Wednesday, December 4-7, 2022 in Phoenix, Arizona.

Key Points: 
  • ADELAIDE, Australia, Dec. 02, 2022 (GLOBE NEWSWIRE) -- Bionomics Limited (Nasdaq: BNOX | ASX: BNO) (Bionomics or Company), a clinical-stage biopharmaceutical company developing novel, allosteric ion channel modulators designed to transform the lives of patients suffering from serious central nervous system (CNS) disorders, today announced it will present data on the development of an oral tablet formulation of BNC210 for the treatment of Social Anxiety Disorder (SAD) and data on the pharmacometrics analysis and drug reformulation of BNC210 for the treatment of PTSD at the 61st Annual meeting of the American College of Neuropsychopharmacology (ACNP) to be held in-person Sunday through Wednesday, December 4-7, 2022 in Phoenix, Arizona.
  • Title: Development of an Improved Oral Tablet Formulation of BNC210, a Negative Allosteric Modulator of the Alpha 7 Nicotinic Acetylcholine Receptor, Suitable for Evaluation as an Acute Treatment for Social Anxiety Disorder.
  • Title: Pharmacometrics Analysis and Drug Reformulation of BNC210 to Optimize its Evaluation in a Phase 2 Trial in PTSD Patients.
  • FOR FURTHER INFORMATION PLEASE CONTACT:

ROSALIND FRANKLIN UNIVERSITY NEUROSCIENTIST AWARDED $2.36 MILLION TO STUDY POTENTIAL THERAPEUTIC TARGETS FOR ANXIETY DISORDERS

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Wednesday, November 30, 2022
Anxiety, Mental health, Doctor of Philosophy, National Institute of Mental Health, Oxytocin, NIMH, Multimedia, Social anxiety disorder, Attention deficit hyperactivity disorder predominantly inattentive, Modulation, Patient, Fear, Hypothalamus, Research, Hypervigilance, Neuroscience, Doctor of Pharmacy, GAD, BNST, Post-traumatic stress disorder, PTSD, RFU, Human, Anxiety disorder, Rosalind Franklin University of Medicine and Science, Medicine, Meat, Pharmaceutical industry

The new award marks the competitive renewal of Dr. Dabrowska's grant, which started in 2017.

Key Points: 
  • The new award marks the competitive renewal of Dr. Dabrowska's grant, which started in 2017.
  • Stress-induced neuropsychiatric disorders such as PTSD are characterized by hypervigilance manifested as constant threat surveillance and disproportionately higher fear reactivity to unpredictable vs. predictable threat signals.
  • The BNST is hyperactive in patients suffering from generalized anxiety disorder (GAD) and PTSD.
  • Social anxiety disorders impact more than 15 million Americans and about six out of every 100 people will have PTSD at some point in their lives.

ANANDA Scientific Announces FDA Approval of the IND for a Clinical Trial exploring treatment of Social Anxiety Disorder (SAD)

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Wednesday, November 30, 2022
Research, FDA, Cannabis, Clinical Trials, Biotechnology, Health, Pharmaceutical, Science, Natural Resources, Trier social stress test, Cannabidiol, US Food Sovereignty Alliance, Principal investigator, Doctor of Philosophy, Alternative medicine, Food, Multimedia, IND, New York University Grossman School of Medicine, Master of Science, National Center for Health Research, Prolonged exposure therapy, Cannabinoid, NYU, Neuroimaging, TSST, UCLA, Psychiatry, Assistant, NIH, Social anxiety disorder, Research, PTSD, LDS, Clinical trial, FDA, Pharmaceutical industry, Medical device, Anxiety, MD, CBD

ANANDA Scientific Inc ., a research focused bio-pharmaceutical company today announced approval by the US Food and Drug Administration (FDA) of the IND application for a clinical trial evaluating Nantheia A1002N5S, an investigational drug using cannabidiol (CBD) in ANANDAs proprietary Liquid Structure delivery technology as a potential treatment for Social Anxiety Disorder.

Key Points: 
  • ANANDA Scientific Inc ., a research focused bio-pharmaceutical company today announced approval by the US Food and Drug Administration (FDA) of the IND application for a clinical trial evaluating Nantheia A1002N5S, an investigational drug using cannabidiol (CBD) in ANANDAs proprietary Liquid Structure delivery technology as a potential treatment for Social Anxiety Disorder.
  • ( Clinical Trials.gov Identifier: NCT05571592 )
    This press release features multimedia.
  • We are delighted to be moving forward with this important study to develop new evidence-based treatments for Social Anxiety Disorder, a distressing and under-addressed condition, said Dr Simon.
  • ANANDA is a leading research-focused biopharmaceutical company pioneering high-caliber clinical studies evaluating therapeutic indications such as PTSD , Radiculopathic Pain , Anxiety and Opioid Use Disorder ( Mt.

Bright Minds Biosciences Appoints Drug Development Executive Mark A. Smith M.D., Ph.D. as Chief Medical Officer

Retrieved on: 
Wednesday, November 23, 2022
Bachelor, Schizophrenia, Epilepsy, Drug, Social anxiety disorder, University, University of California, San Diego Performance-Based Skills Assessment, Psychiatry, NIMH, Neuropsychiatry, Disorder, Agitation, Yale University, Pain, Mental health, Knowledge, Therapy, Bright Minds In Action Learning Village, Anxiety, Drug development, Senior, CNS, Medical research, Depression, Innovation, Sleep, Teva Pharmaceuticals, Pharmacology, Psilocybin, PTSD, Duke University Hospital, CSE, Dravet syndrome, Clinical trial, Shire (pharmaceutical company), DuPont (1802–2017), Pharmaceutical industry, Physiology, Philosophy, Science

VANCOUVER, British Columbia, Nov. 23, 2022 (GLOBE NEWSWIRE) -- Bright Minds Biosciences (“Bright Minds,” “BMB” or the “Company”) (Nasdaq: DRUG) (CSE: DRUG), a biotechnology company focused on developing novel drugs for the targeted treatment of neuropsychiatric disorders, epilepsy, and pain, today announced that Mark A. Smith M.D., Ph.D. will join the Company as Chief Medical Officer, effective December 1, 2022. The Company also announces that Dr. Revati Shreeniwas’ engagement with Bright Minds as Chief Medical Officer has been terminated.

Key Points: 
  • The Company also announces that Dr. Revati Shreeniwas engagement with Bright Minds as Chief Medical Officer has been terminated.
  • A seasoned executive in CNS drug development, Dr. Smith has directed over 50 clinical trials across all stages of development.
  • Its an exciting time to join Bright Minds with the Phase I trial for its lead program, BMB-101, currently underway.
  • Prior to joining Bright Minds, Dr. Smith was Chief Medical Officer at VistaGen Therapeutics, where he led the clinical development of drug candidates in the areas of major depression, social anxiety disorder, and depression through all phases of development.

Vistagen Reports Second Quarter Financial Results and Provides Corporate Update

Retrieved on: 
Thursday, November 10, 2022
Mental Health, Health, Neurology, Clinical Trials, Pharmaceutical, Biotechnology, Review, Data analysis, Liebowitz social anxiety scale, PIN, LSAS, NMDA, IND, Risk, Adult, Calendar, Nasal spray, PALISADE, Probenecid, Depression, Central nervous system disease, Food, Nasdaq, Research, Fear, Anxiety, PH94B, COVID-19, Neuron, MDD, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, R, Hallucination, SEC, Annual report, Brain, Social anxiety disorder, SAD, Safety, U.S. Securities and Exchange Commission, Time, Company, Grammatical mood, PH10, Clinical trial, Patient, OLS, Therapy, Drug discovery, Hamilton Rating Scale for Depression, Central nervous system, Major depressive disorder, Industry, Decision-making, CNS, FDA, Trial of the century, Pharmaceutical industry, Fine chemical, G&A, Ajda

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 reported financial results for its fiscal year 2023 second quarter ended September 30, 2022 and provided a corporate update.

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 reported financial results for its fiscal year 2023 second quarter ended September 30, 2022 and provided a corporate update.
  • During the past quarter, Vistagen achieved several important milestones to advance our CNS pipeline.
  • Vistagen anticipates topline results from this exploratory Phase 2A AjDA trial during the first quarter of calendar 2023.
  • Vistagen will host a conference call and live audio webcast this afternoon at 5:00 p.m. Eastern Time to discuss its financial results for its second quarter fiscal year 2023 ended September 30, 2022 and provide a corporate update.