Hamilton Rating Scale for Depression

Neumora Therapeutics Announces Initiation of Phase 3 Clinical Program for Navacaprant (NMRA-140) in Major Depressive Disorder

Retrieved on: 
Tuesday, July 18, 2023
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Neumora Therapeutics, Inc. (Neumora), a clinical-stage biopharmaceutical company redefining neuroscience drug development, today announced the planned initiation of the KOASTAL Program, a Phase 3 pivotal clinical program designed to evaluate the efficacy and safety of navacaprant (NMRA-140) monotherapy for the treatment of major depressive disorder (MDD).

Key Points: 
  • Neumora Therapeutics, Inc. (Neumora), a clinical-stage biopharmaceutical company redefining neuroscience drug development, today announced the planned initiation of the KOASTAL Program, a Phase 3 pivotal clinical program designed to evaluate the efficacy and safety of navacaprant (NMRA-140) monotherapy for the treatment of major depressive disorder (MDD).
  • The planned initiation follows the successful completion of an End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) and a robust Phase 2 study with navacaprant.
  • The KOASTAL Program will also include an open-label extension study, KOASTAL-LT, designed to evaluate the long-term safety of navacaprant.
  • The Phase 2 clinical trial was initiated by BlackThorn Therapeutics prior to its acquisition by Neumora and was a double-blind, placebo-controlled, randomized, multicenter trial of once-daily navacaprant monotherapy compared to placebo.

Vistagen Reports New Preclinical Data Supporting Itruvone (PH10) Nasal Spray’s Potential Antidepressant Activity via Peripheral Nasal Neurons without Entry into the Brain

Retrieved on: 
Monday, July 17, 2023
Mental Health, Health, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, Tissue, Neuron, Hallucination, Central nervous system, Depression, Nasal cavity, Week, Anxiety, Brain, CNS, Șaeș, Plasma, MDD, Electrophysiology, Major depressive disorder, Blood, Hamilton Rating Scale for Depression, Safety, Pharmaceutical industry

The study demonstrated that a single intranasal administration of radiolabeled itruvone ([14C]PH10) was essentially undetectable in the brain and most other tissues, including blood and plasma.

Key Points: 
  • The study demonstrated that a single intranasal administration of radiolabeled itruvone ([14C]PH10) was essentially undetectable in the brain and most other tissues, including blood and plasma.
  • “Itruvone’s unique mechanism of action is further demonstrated in this new carbon-labeled study,” said Shawn Singh, Chief Executive Officer of Vistagen.
  • This can lead to unwanted side effects and create potential drug-drug interaction concerns for some individuals who require additional medications for other medical conditions.
  • In that study, itruvone was administered intranasally at a daily dose of 3.2 μg and 6.4 μg for 8 weeks.

Vistagen Announces Results of Successful U.S. Phase 1 Study of Itruvone (PH10), Enabling U.S. Phase 2B Development for Treatment of Major Depressive Disorder

Retrieved on: 
Wednesday, June 21, 2023
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Phase 1 clinical trial of itruvone (PH10), the Company’s investigational rapid-onset pherine nasal spray for the treatment of major depressive disorder (MDD).

Key Points: 
  • Phase 1 clinical trial of itruvone (PH10), the Company’s investigational rapid-onset pherine nasal spray for the treatment of major depressive disorder (MDD).
  • Phase 1 study build on successful Phase 1 studies and a positive randomized, double-blind, placebo-controlled Phase 2A study of itruvone nasal spray in MDD previously conducted in Mexico and enable Phase 2B development of itruvone in the U.S. as an innovative stand-alone rapid-onset product candidate for treatment of MDD.
  • There were no reported serious adverse events (SAEs) or discontinuations due to adverse events (AEs) in the study.
  • Phase 1 study, along with the results of Vistagen’s nonclinical studies and three prior clinical studies, inform Phase 2B development of itruvone as a potential rapid-onset stand-alone treatment of MDD with a favorable safety profile.

Psycheceutical Bioscience, Inc. Announces Observational Research Results for NeuroDirect™ Ketamine Topical Cream in Treating PTSD

Retrieved on: 
Tuesday, March 21, 2023
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The preliminary observational data indicates that the non-systemic topical cream could be more effective at treating PTSD symptoms than cur­rent ketamine treatment options, which utilize systemic delivery methods.

Key Points: 
  • The preliminary observational data indicates that the non-systemic topical cream could be more effective at treating PTSD symptoms than cur­rent ketamine treatment options, which utilize systemic delivery methods.
  • Additionally, the study supports the Company’s belief that the topical cream approach would be more cost-effective than current ketamine therapy options.
  • "Administering ketamine with NeuroDirect drug delivery technology has shown observational promise in addressing undesirable side effects and providing therapeutic benefits," said Dr. Ronald Aung-Din, Clinical Advisor for Psycheceutical and inventor of the NeuroDirect™ delivery system.
  • Patients indicated relief of PTSD symptoms within minutes after using NeuroDirect keta­mine applied as a topical cream on the back of the neck.

Alto Neuroscience Presents New Data Leveraging EEG and Machine Learning to Predict Individual Response to Antidepressants at the 61st Annual Meeting of the American College of Neuropsychopharmacology

Retrieved on: 
Thursday, December 8, 2022
Science, Biotechnology, Research, Pharmaceutical, General Health, Health, Mental Health, Clinical Trials, American College, RCT, SSRI, Genetics, Biomarker, Patient, Biology, PTSD, Disease, FDA, Neuroscience, Mental health, American College of Neuropsychopharmacology, EEG, Failure, Brain, Hamilton Rating Scale for Depression, Depression, Machine learning, Cognition, MDD, Medical device, Pharmaceutical industry, Risk management, Selective serotonin reuptake inhibitor

The data we presented at ACNP further validate our work and exemplify the future of precision psychiatry in changing the mental health treatment landscape.

Key Points: 
  • The data we presented at ACNP further validate our work and exemplify the future of precision psychiatry in changing the mental health treatment landscape.
  • Alto developed and validated a machine learning model for predicting individual response to SSRIs using 19-channel resting-state electroencephalography (rsEEG) data from two MDD clinical trials (total N= 346).
  • Data from 93 MDD patients in the SSRI arm of an open-label clinical trial were used for model development.
  • These results demonstrate that robust prediction of individual response to antidepressants can be achieved leveraging EEG and machine learning in a specific and reproducible manner developed by Alto Neuroscience.

Vistagen Receives FDA Fast Track Designation for Development of PH10 to Treat Major Depressive Disorder

Retrieved on: 
Tuesday, December 6, 2022
Mental Health, FDA, Health, Clinical Trials, Pharmaceutical, Biotechnology, Fast Track, KBT, Standard of care, Neuron, Therapy, Catecholamine, Food, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Central nervous system, Major depressive disorder, Patient, PH10, Anxiety, Annual report, Nasal spray, Central nervous system disease, MOA, Hamilton Rating Scale for Depression, FDA, Ketamine, COVID-19, PH94B, Safety, Risk, Brain, United, Medication, Depression, Hallucination, Medical research, CNS, MDD, Grammatical mood, Pharmaceutical industry

Vistagen is laser focused on bringing an innovative treatment option to individuals suffering with debilitating depression.

Key Points: 
  • Vistagen is laser focused on bringing an innovative treatment option to individuals suffering with debilitating depression.
  • The FDAs grant of the Fast Track designation for the development of PH10 in major depressive disorder is a significant regulatory milestone, aligned with our belief in PH10s potential to improve the standard of care in a significant market where new and differentiated treatments are urgently needed, stated Shawn Singh, Chief Executive Officer of Vistagen.
  • With 21 million adults in the U.S. suffering at least one major depressive episode in the past year, potentially millions of individuals are not getting the help they need.
  • We look forward to working with the FDAs Fast Track program as we advance development of PH10 in the United States.

Vistagen Receives FDA “Study May Proceed” Letter Under its Investigational New Drug Application for PH10 to Treat Major Depressive Disorder

Retrieved on: 
Wednesday, November 30, 2022
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Phase 1 clinical trial under Vistagens newly filed Investigational New Drug (IND) application for clinical development of PH10 in the U.S. as a standalone treatment for major depressive disorder (MDD).

Key Points: 
  • Phase 1 clinical trial under Vistagens newly filed Investigational New Drug (IND) application for clinical development of PH10 in the U.S. as a standalone treatment for major depressive disorder (MDD).
  • People living with major depressive disorder urgently need new and differentiated therapies we are committed to addressing that need.
  • The FDAs clearance to advance our clinical program for PH10 in the U.S. is another important milestone for our company, stated Shawn Singh, Chief Executive Officer of Vistagen.
  • The Company explicitly disclaims any obligation to update any forward-looking statements, other than as may be required by law.

Praxis Precision Medicines Provides Corporate Update and Reports Third Quarter 2022 Financial Results

Retrieved on: 
Wednesday, November 9, 2022
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BOSTON, Nov. 09, 2022 (GLOBE NEWSWIRE) -- Praxis Precision Medicines, Inc. (NASDAQ: PRAX), a clinical-stage biopharmaceutical company translating genetic insights into the development of therapies for central nervous system (CNS) disorders characterized by neuronal excitation-inhibition imbalance, today provided a corporate update and reported financial results for the third quarter of 2022.

Key Points: 
  • Praxis is currently engaged with the FDA and expects to initiate a Phase 2, placebo-controlled trial in the first quarter of 2023.
  • Praxis expects to initiate a PRAX-628 Phase 1 study in the fourth quarter of 2022 and subsequently initiate a Phase 2 study in focal epilepsy in 2023.
  • Praxis Precision Medicines is a clinical-stage biopharmaceutical company translating genetic insights into the development of therapies for CNS disorders characterized by neuronal excitation-inhibition imbalance.
  • Praxis undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future developments or otherwise.

Vistagen Reports Second Quarter Financial Results and Provides Corporate Update

Retrieved on: 
Thursday, November 10, 2022
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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.

Sage Therapeutics and Biogen Present Further Analyses from Phase 3 SKYLARK Study of Zuranolone in Postpartum Depression at the European College of Neuropsychopharmacology (ECNP) Congress

Retrieved on: 
Monday, October 17, 2022
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(Nasdaq: SAGE) and Biogen Inc. (Nasdaq: BIIB) today presented additional data from the Phase 3 SKYLARK Study of zuranolone in adult women with postpartum depression (PPD), at the 35th European College of Neuropsychopharmacology (ECNP) Congress, taking place October 15-18, 2022, in Vienna, Austria.

Key Points: 
  • (Nasdaq: SAGE) and Biogen Inc. (Nasdaq: BIIB) today presented additional data from the Phase 3 SKYLARK Study of zuranolone in adult women with postpartum depression (PPD), at the 35th European College of Neuropsychopharmacology (ECNP) Congress, taking place October 15-18, 2022, in Vienna, Austria.
  • The study population was diverse, including approximately 22% Black or African American women and 38% identifying ethnically as Hispanic or Latina women.
  • The results of the SKYLARK Study are incredibly encouraging and show the potential positive impact zuranolone could have for women with PPD.
  • In the SKYLARK Study, zuranolone was generally well-tolerated, with a safety profile consistent with that observed in the clinical development program to date.