LYT-300


Associated tags: Fragile X-associated tremor/ataxia syndrome, Anxiety, GABAA, Clinical Trials, Biotechnology, Health, Pharmaceutical, Mental Health, PureTech Health, Pharmaceutical industry, PRTC, LSE, Patient, Therapy, General Health, Allopregnanolone, Glyph, Science, Research, Depression, Neurosteroid, CNS

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

Retrieved on: 
Tuesday, November 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.

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: 
Tuesday, August 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: 
Wednesday, June 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: 
Tuesday, February 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: 
Monday, December 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 Meets Milestone of Achieving Oral Bioavailability of Allopregnanolone in Healthy Adults Dosed with LYT-300

Retrieved on: 
Tuesday, June 14, 2022
Health, Neurology, Clinical Trials, General Health, Pharmaceutical, Biotechnology

This is a key milestone for the candidate, which is designed to overcome the normally poor oral bioavailability of allopregnanolone to deliver its proven efficacy via simple, convenient oral dosing.

Key Points: 
  • This is a key milestone for the candidate, which is designed to overcome the normally poor oral bioavailability of allopregnanolone to deliver its proven efficacy via simple, convenient oral dosing.
  • PureTech has previously presented data in non-human primates with LYT-300 demonstrating significantly greater oral bioavailability than orally administered allopregnanolone.
  • The Glyph platform is designed to leverage the bodys natural lipid absorption and transport process to overcome these limitations to enable oral administration.
  • Demonstrating oral bioavailability with the Glyph platform opens up the possibility of developing other natural neurosteroids and a number of bioactive molecules as oral therapies to treat a range of serious diseases.