Allopregnanolone

Delix Presents Interim Data From Phase I Trial of Novel Neuroplastogen at ACNP Annual Meeting

Retrieved on: 
星期三, 十二月 6, 2023
Biotechnology, Pharmaceutical, General Health, Health, Mental Health, Genetics, Clinical Trials, Other Health, CNS, Psilocybin, Bowdle, South Dakota, DMT, Phase 1, Therapy, DSM-IV codes, Prefrontal cortex, Plasma, Food, CSF, SAD, Hallucination, Patient, Memantine, Neuron, American College, Pharmacokinetics, Science, Cardiotoxicity, Mysticism, MD, Drug discovery, Psychiatry, Coronavirus Scientific Advisory Board, Ketamine, Drug development, Traffic barrier, Pharmaceutical industry, Generic drug, Vaccine, Medical imaging, Ramipril, Allopregnanolone, Safety

Delix Therapeutics , a clinical-stage neuroscience company developing novel neuroplasticity-promoting therapeutics for psychiatric and neurological disorders, today announced interim results from the Phase 1 trial evaluating DLX-001, a novel neuroplastogen, in healthy volunteers, which were presented at the 2023 American College of Neuropsychopharmacology (ACNP) Annual Meeting in Tampa, Florida.

Key Points: 
  • Delix Therapeutics , a clinical-stage neuroscience company developing novel neuroplasticity-promoting therapeutics for psychiatric and neurological disorders, today announced interim results from the Phase 1 trial evaluating DLX-001, a novel neuroplastogen, in healthy volunteers, which were presented at the 2023 American College of Neuropsychopharmacology (ACNP) Annual Meeting in Tampa, Florida.
  • “Delix is excited to share these data from DLX-001, the first novel neuroplastogen to enter clinical testing.
  • These data reinforce the potential of our broader neuroplastogen platform to develop therapies that can repair damaged neurons,” said Delix CEO Mark Rus.
  • I look forward to leveraging his considerable experiences as we progress our novel neuroplastogen platform and build Delix into a leading neuroscience company."

PureTech's LYT-300 (Oral Allopregnanolone) Achieved Primary Endpoint in a Phase 2a Acute Anxiety Trial in Healthy Volunteers

Retrieved on: 
星期二, 十一月 14, 2023
Mental Health, Research, Clinical Trials, Biotechnology, Health, Pharmaceutical, General Health, Other Science, Science, CNS, Allopregnanolone, Schizophrenia, Daphne, Trier social stress test, PureTech Health, Anxiety, Neurosteroid, Patient, Multimedia, LSE, KarXT, Alprazolam, PRTC, Psychiatry, FRCPC, Epilepsy, Pharmacology, Therapy, Benzodiazepine, Stress-related disorders, DSM-IV codes, MPH, University, TSST, Massachusetts General Hospital, Public health, Glyph, Central nervous system, Volunteering, Hospital, Pharmaceutical industry, MD

The trial was designed to evaluate the salivary cortisol response in the Trier Social Stress Test (TSST), a validated clinical model of anxiety in healthy volunteers.

Key Points: 
  • The trial was designed to evaluate the salivary cortisol response in the Trier Social Stress Test (TSST), a validated clinical model of anxiety in healthy volunteers.
  • View the full release here: https://www.businesswire.com/news/home/20231113556006/en/
    PureTech announced topline results from its Phase 2a, randomized, placebo-controlled, proof-of-concept trial of LYT-300 (oral allopregnanolone).
  • The trial was designed to evaluate the salivary cortisol response in the Trier Social Stress Test (TSST), a validated clinical model of anxiety in healthy volunteers.
  • An increase in cortisol levels after the TSST is a physiological response and an objective biomarker of acute stress.

Zuranolone for postpartum depression: Hope, hype or both?

Retrieved on: 
星期四, 八月 31, 2023
Exercise, PPD, Human, Pregnancy, Depression, Awareness, Sertraline, Interpersonal psychotherapy, COVID-19, Mental health, Woman, Psychotherapy, Medicine, Research, Edinburgh Postnatal Depression Scale, Heart rate, Allopregnanolone, USD, Hormone, Mother, Dutch Association of Mental Health and Addiction Care, Blame, Zuranolone, Lactation, Sleep hygiene, Progesterone, FDA, Addiction, Safety, Pharmaceutical industry, Medical device, Nursing, Birth control, Health insurance

While mothers with postpartum depression have always faced barriers accessing the care they need, things have been particularly bad since the onset of the COVID-19 pandemic.

Key Points: 
  • While mothers with postpartum depression have always faced barriers accessing the care they need, things have been particularly bad since the onset of the COVID-19 pandemic.
  • However, the pandemic also coincided with a period of significant innovation in treatment that may increase access to and effectiveness of care.

Medications specifically for PPD

    • It represented the first of an entirely new class of medicines for postpardum depression (PPD), which target the steep decrease in hormones after delivery.
    • Brexanolone is a synthetic version of allopregnanolone, a naturally occurring substance made from progesterone, that helps the brain regulate stress.
    • Its approval in the U.S. was especially notable for two reasons: it was the first medicine approved specifically for the treatment of PPD, and it takes effect especially quickly — within 60 hours.
    • Early studies of zuranolone suggest PPD symptom improvement can be observed as early as three days after starting the treatment.

Behind the hype

    • If approved in Canada, it would also add to the array of effective treatments that already exist.
    • These include evidence-based talking therapies like cognitive behavioural therapy and interpersonal psychotherapy, which are first-line treatments for mild to moderate PPD.
    • Antidepressant medications like the selective serotonin re-uptake inhibitors (SSRIS, such as sertraline and escitalopram) are also widely available and usually recommended as second-line therapies for most individuals with PPD.
    • Only individuals with more severe depression that emerged between the third trimester of pregnancy and four weeks post-delivery could be enrolled.

PPD is still underdiagnosed

    • However, it is important in this case that we not lose sight of the fact that PPD is a vastly underdetected and undertreated problem for which safe and effective treatments already exist.
    • Research into treatments for PPD and the federal government’s actions in appointing a Minister of Mental Health and Addictions and prioritizing perinatal parents are also cause for genuine optimism.
    • While zuranolone is raising awareness about PPD, it’s important to highlight the need to develop national quality standards and Canadian-specific stepped-care models and care pathways.

Food and Drug Administration Approves First Postpartum Depression Pill, Research Led by Northwell Health’s Feinstein Institutes

Retrieved on: 
星期一, 八月 7, 2023
Women, Biotechnology, Pharmaceutical, Health, FDA, Mental Health, Consumer, Clinical Trials, GABA, PPD, Medicine, JAMA, NAS, Feinstein Institutes for Medical Research, Neurochemistry, Woman, Multimedia, Research, Northwell Health, The American Journal of Psychiatry, Bangladesh Technical Education Board, American Medical Association, American Journal, Behavioural sciences, Journal, Patient, Zuranolone, Grammatical mood, Psychiatry, Credit, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, NIH, Medical research, Food, Safety, Allopregnanolone, Pharmaceutical industry, MD

View the full release here: https://www.businesswire.com/news/home/20230807136425/en/

Key Points: 
  • View the full release here: https://www.businesswire.com/news/home/20230807136425/en/
    The national clinical trials for zuranolone were led by the Feinstein Institutes for Medical Research at Northwell Health.
  • “After years of dedicated research and collaboration with other scientists, women living with postpartum depression have a new, at-home, 14-day treatment option that has the potential to alleviate their symptoms,” said Dr. Deligiannidis.
  • Deligiannidis is a leader in clinical trials for postpartum depression, a condition that affects millions,” said Kevin J. Tracey, MD, president and CEO of the Feinstein Institutes, Karches Family Distinguished Chair in Medical Research.
  • “The FDA approval stemming from her work will make available new therapeutic options that are clearly needed.”
    The Feinstein Institutes and Dr. Deligiannidis lead in researching new methods to diagnose and treat perinatal depression.

PureTech Awarded up to $11.4 Million from U.S. Department of Defense to Advance LYT-300 (Oral Allopregnanolone) for Fragile X-associated Tremor/Ataxia Syndrome

Retrieved on: 
星期二, 八月 1, 2023
Mental Health, Health, Clinical Trials, General Health, Pharmaceutical, Biotechnology, PRTC, LSE, Defense Health Agency, University of California, Davis, Tremor, Anxiety, University, Therapy, U.S. Department of Defense Strategy for Operating in Cyberspace, United States Department of Defense, Ageing, PureTech Health, FMR1, Research, Medicine, Development director, Element, Veteran, CNS, Dementia, Trial of the century, Science, Assistant, Intellectual disability, FXS, Fragile X syndrome, UC, Patient, Department of Defense Serum Repository, United States Army Medical Research and Development Command, Spectrum, United States Army Medical Research Institute of Infectious Diseases, MIND Institute, FXTAS, Office of the Assistant Secretary for Health, Assistant Secretary of Defense for Health Affairs, Glyph, Cannabidiol, Safety, Allopregnanolone, Pharmaceutical industry, Vaccine, Defense, Fragile

The funds will support a Phase 2 trial of LYT-300 in collaboration with the University of California, Davis (UC Davis).

Key Points: 
  • The funds will support a Phase 2 trial of LYT-300 in collaboration with the University of California, Davis (UC Davis).
  • Both conditions are the result of repeated elements in the Fragile X Messenger Ribonucleoprotein Gene 1 (FMR1) gene.
  • Opinions, interpretations, conclusions and recommendations are those of the author and are not necessarily endorsed by the Department of Defense.
  • In addition to LYT-300, which is being advanced in three indications, PureTech is progressing multiple CNS-focused programs derived from its Glyph platform.

PureTech Initiates Phase 2a Clinical Trial of LYT-300 (Oral Allopregnanolone) for the Potential Treatment of Anxiety Disorders

Retrieved on: 
星期三, 六月 21, 2023
Biotechnology, Mental Health, Health, Pharmaceutical, Clinical Trials, PRTC, Fat, PPD, LSE, Allopregnanolone, Depression, Therapy, Anxiety, Neurosteroid, Clinical trial, PureTech Health, Patient, GABAA, Platform supply vessel, Liver, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Food, Pharmaceutical industry

LYT-300 is PureTech’s wholly-owned therapeutic candidate for the potential treatment of neurological and neuropsychiatric disorders, including anxiety disorders and postpartum depression (PPD).

Key Points: 
  • LYT-300 is PureTech’s wholly-owned therapeutic candidate for the potential treatment of neurological and neuropsychiatric disorders, including anxiety disorders and postpartum depression (PPD).
  • These oral analogs may have different pharmacological effects than endogenous allopregnanolone and therefore may not capture its full therapeutic potential.
  • Results for the placebo-controlled, Phase 2a, proof-of-concept trial using a validated clinical model of anxiety in healthy volunteers are anticipated by the end of 2023.
  • Additionally, the open-label, Phase 2a, proof-of-concept clinical trial in patients with postpartum depression is expected to begin in the second half of 2023.

PureTech to Advance LYT-300 (Oral Allopregnanolone) for the Potential Treatment of Anxiety Disorders and Postpartum Depression

Retrieved on: 
星期二, 二月 14, 2023
Mental Health, Research, FDA, Clinical Trials, Biotechnology, Health, Pharmaceutical, General Health, Science, Allopregnanolone, LSE, Social anxiety, Woman, Therapy, Village development committee (Nepal), PPD, PureTech Health, Patient, Clinical trial, Depression, Anxiety, PRTC, GABAA, Multimedia, R, Pharmaceutical industry, Vaccine, Glyph

PureTech Health plc (Nasdaq: PRTC, LSE: PRTC) ("PureTech" or the "Company"), a clinical-stage biotherapeutics company dedicated to changing the treatment paradigm for devastating diseases, today announced that it will advance LYT-300 (oral allopregnanolone) for the potential treatment of anxiety disorders and postpartum depression (PPD).

Key Points: 
  • PureTech Health plc (Nasdaq: PRTC, LSE: PRTC) ("PureTech" or the "Company"), a clinical-stage biotherapeutics company dedicated to changing the treatment paradigm for devastating diseases, today announced that it will advance LYT-300 (oral allopregnanolone) for the potential treatment of anxiety disorders and postpartum depression (PPD).
  • An open-label, Phase 2a, proof-of-concept clinical trial in women with PPD is expected to initiate in the second half of 2023.
  • “Using our proprietary Glyph™ platform, we have made natural allopregnanolone orally bioavailable without permanently chemically modifying the natural neurosteroid.
  • It has demonstrated a rapid onset of action for the treatment of depression, as well as the potential to treat other neurological conditions, including anxiety, but its poor oral bioavailability has limited its therapeutic potential.

PureTech’s LYT-300 (Oral Allopregnanolone) Demonstrates Oral Bioavailability, Tolerability and GABAA Receptor Target Engagement in Healthy Volunteers

Retrieved on: 
星期一, 十二月 19, 2022
Biotechnology, FDA, Health, Pharmaceutical, Clinical Trials, Lymphatic system, PAM, Annual report, Patient, U.S. FDA, Journal of the Neurological Sciences, Monash University, Benzodiazepine, University of Melbourne, Disorder, Liver, Immune system, Journal, Environment, Depression, Evaluation, Angewandte Chemie, Kathryn Bullock, PRTC, Drug development, Pharmacy, Allopregnanolone, FDA, Safety, Clinical trial, PPD, LSE, CDER, GABA, Multimedia, Fat, Food, PureTech Health, Pharmacology, Parkinson's disease, Monash Institute of Medical Research, Therapy, Journal of Controlled Release, Platform supply vessel, GABAA, Research, Control, Pharmaceutical industry, Vaccine, CBD, Glyph, List of Nature Research journals

View the full release here: https://www.businesswire.com/news/home/20221219005209/en/

Key Points: 
  • View the full release here: https://www.businesswire.com/news/home/20221219005209/en/
    PureTech announced topline results for LYT-300 (oral allopregnanolone), a therapeutic candidate in development for neurological and neuropsychological conditions.
  • The results show that oral administration of LYT-300 achieved blood levels of allopregnanolone at or above those associated with therapeutic benefit and results in exposure-dependent target engagement of GABAA receptors.
  • The impact of LYT-300 on b-EEG and other markers of GABAA target engagement were also assessed.
  • PureTech completed a Phase 1 clinical trial of LYT-300 in 2022, which demonstrated oral bioavailability, tolerability and GABAA receptor target engagement in healthy volunteers.

PureTech Announces Publication of Research from Collaborators Demonstrating PureTech’s Glyph™ Platform Enhances Oral Absorption of Buprenorphine (a Clinically-Validated Opioid Replacement Therapy)

Retrieved on: 
星期二, 四月 12, 2022
Biotechnology, Health, Science, Pharmaceutical, Research, Company, Private Securities Litigation Reform Act, Cancer, Pharmacy, Synthetic, Journal, PRTC, BUP, Therapy, U.S. FDA, Control, Multimedia, Fat, Patient, Liver, Research, SEC, Frontiers Media, Risk, Environment, Platform supply vessel, Monash University, Monash Institute of Medical Research, University of Melbourne, Pain management, Chem, Allopregnanolone, Lymphatic system, Immune system, Technology, Biology, Twitter, LSE, Brain, Chemistry, Degenerative disease, Journal of Controlled Release, Prodrug, BIG, Annual report, FDA, PureTech Health, Buprenorphine, Axis, Pharmaceutical industry, Trevaskis, Glyph, Pharmacology, Frontiers

View the full release here: https://www.businesswire.com/news/home/20220411005986/en/

Key Points: 
  • View the full release here: https://www.businesswire.com/news/home/20220411005986/en/
    PureTech announced the publication of preclinical proof-of-concept showing up to 20-fold oral bioavailability enhancement by the Glyph platform of buprenorphine, a clinically-validated opioid replacement therapy.
  • Results from this study further amplify the breadth of the Glyph delivery technology and its ability to use new chemistry and molecules for versatile applications.
  • The Glyph technology generates novel orally dosed prodrugs by reversibly linking small molecule drugs to dietary fat molecules.
  • PureTechs LYT-300 is the first therapeutic candidate generated by the Glyph technology platform to enter the clinic.

Seven Arizona Bioscience Startups to Watch in 2022

Retrieved on: 
星期四, 二月 24, 2022
Other Health, General Health, Pharmaceutical, Philanthropy, Oncology, Medical Devices, Foundation, Cardiology, Veterinary, Biotechnology, Nursing, Health, Civic, Lung, Carbon, Hydrocephalus, Growth, Cardiology, Respiratory disease, Entrepreneurship, PETS, Association, Culture, Nursing, Electrocardiography, Prostate, Intubation, Allopregnanolone, Health, Degenerative disease, Helium, Neuron, Navi, Hospital, Surgeon, Oxygen, Bacteria, Neurodegeneration, Science, Brain, Colorectal cancer, Breast, Arizona Center, COPD, Patient, Scalp, Quality of life, Cancer, Synapse, ST, United States Navy Nurse Corps, Research, Program, CEO, Policy, Pharmaceutical industry, Renewable energy, Medical imaging, Medicine, Purina

The 2022 program participants include three Tucson-based startups, two from Phoenix and one each from Scottsdale and Surprise.

Key Points: 
  • The 2022 program participants include three Tucson-based startups, two from Phoenix and one each from Scottsdale and Surprise.
  • The Flinn Foundation program provides these entrepreneurs with the tools they will need to continue to grow their firms and attract investors.
  • The Tucson-based firm was one of five companies that won Purina's 2022 Pet Care Innovation Prize.
  • Since the program was launched in 2014 to foster bioscience entrepreneurship, the Flinn Foundation has competitively selected 54 Arizona companies and provided $1.6 million in support for the program.