Positive and Negative Syndrome Scale

Lyndra Therapeutics Presents Data on Long-Acting Oral Weekly Risperidone (LYN-005) at American Society of Clinical Psychopharmacology 2023 Annual Conference

Retrieved on: 
Wednesday, May 31, 2023

Additionally:

Key Points: 
  • Additionally:
    The simulated minimum steady-state blood plasma concentration of risperidone for people taking oral weekly risperidone (LYN-005) doses of 15, 30, and 45 mg maintained effective concentrations.
  • No apparent trend was observed between simulated average steady-state blood plasma concentrations with oral weekly risperidone and symptoms as measured by PANSS score.
  • Lyndra’s long-acting oral weekly risperidone is designed to enable a week-long dose of risperidone to be delivered in a single oral capsule.
  • Currently, the only long-acting medicines available for schizophrenia require injections, and data show that they are used by a minority of patients.

Newron Presents Exciting New Data From Study 014/015 at CINP World Congress of Neuropsychopharmacology and the 2023 Congress of the Schizophrenia International Research Society (SIRS)

Retrieved on: 
Monday, May 15, 2023

The study showed that the addition of evenamide to antipsychotics was well tolerated, with low incidence of treatment-emergent adverse events.

Key Points: 
  • The study showed that the addition of evenamide to antipsychotics was well tolerated, with low incidence of treatment-emergent adverse events.
  • 97% of patients completed six weeks of treatment, and more than 90% of the completers chose to continue with evenamide treatment into the long-term extension study (study 015).
  • Final efficacy and safety results from all 161 patients at the six-week primary endpoint of Study 014 were announced in March 2023 .
  • The multi-modal-benefits observed across various domains with evenamide also validate extensive academic research, suggesting that TRS results from excessive glutamate signalling.

EQS-News: Newron presents exciting new data from study 014/015 at CINP World Congress of Neuropsychopharmacology and the 2023 Congress of the Schizophrenia International Research Society (SIRS)

Retrieved on: 
Monday, May 15, 2023

The study showed that the addition of evenamide to antipsychotics was well tolerated, with low incidence of treatment-emergent adverse events.

Key Points: 
  • The study showed that the addition of evenamide to antipsychotics was well tolerated, with low incidence of treatment-emergent adverse events.
  • 97% of patients completed six weeks of treatment, and more than 90% of the completers chose to continue with evenamide treatment into the long-term extension study (study 015).
  • Final efficacy and safety results from all 161 patients at the six-week primary endpoint of Study 014 were announced in March 2023.
  • The multi-modal-benefits observed across various domains with evenamide also validate extensive academic research, suggesting that TRS results from excessive glutamate signalling.

EQS-News: Newron announces 2022 financial results and provides outlook for 2023

Retrieved on: 
Thursday, March 16, 2023

Milan, Italy, March 14, 2023, 7 am CET – Newron Pharmaceuticals S.p.A. (“Newron”) (SIX: NWRN, XETRA: NP5), a biopharmaceutical company focused on the development of novel therapies for patients with diseases of the central and peripheral nervous system, today announced its financial results and operational highlights for the business year ended December 31, 2022, and provided an outlook for 2023.

Key Points: 
  • Milan, Italy, March 14, 2023, 7 am CET – Newron Pharmaceuticals S.p.A. (“Newron”) (SIX: NWRN, XETRA: NP5), a biopharmaceutical company focused on the development of novel therapies for patients with diseases of the central and peripheral nervous system, today announced its financial results and operational highlights for the business year ended December 31, 2022, and provided an outlook for 2023.
  • The results showed that the addition of evenamide improved symptoms of psychosis in patients with TRS.
  • Recruitment at treatment centers in Europe, Asia and Latin America is ongoing and results are expected in 2023.
  • ESG focus areas and objectives for 2023 have been defined and Newron’s Annual ESG reporting efforts commence with the Annual Report 2022 published today.

Newron Announces 2022 Financial Results and Provides Outlook For 2023

Retrieved on: 
Tuesday, March 14, 2023

Newron Pharmaceuticals S.p.A. (“Newron”) (SIX: NWRN, XETRA: NP5), a biopharmaceutical company focused on the development of novel therapies for patients with diseases of the central and peripheral nervous system, today announced its financial results and operational highlights for the business year ended December 31, 2022, and provided an outlook for 2023.

Key Points: 
  • Newron Pharmaceuticals S.p.A. (“Newron”) (SIX: NWRN, XETRA: NP5), a biopharmaceutical company focused on the development of novel therapies for patients with diseases of the central and peripheral nervous system, today announced its financial results and operational highlights for the business year ended December 31, 2022, and provided an outlook for 2023.
  • The results showed that the addition of evenamide improved symptoms of psychosis in patients with TRS.
  • Recruitment at treatment centers in Europe, Asia and Latin America is ongoing and results are expected in 2023.
  • ESG focus areas and objectives for 2023 have been defined and Newron’s Annual ESG reporting efforts commence with the Annual Report 2022 published today.

Karuna Therapeutics Reports Fourth Quarter and Full Year 2022 Financial Result and Provides General Business Updates

Retrieved on: 
Thursday, February 23, 2023

Karuna is advancing a pipeline of novel drug candidates for the treatment of various psychiatric and neurological conditions.

Key Points: 
  • Karuna is advancing a pipeline of novel drug candidates for the treatment of various psychiatric and neurological conditions.
  • Results from the Phase 3 EMERGENT-2 trial in schizophrenia were presented at the 2022 Neuroscience Education Institute and the 2022 American College of Neuropsychopharmacology Annual Meeting in the fourth quarter of 2022.
  • The Company recognized licensing revenue of $5.3 million for the fourth quarter of 2022, and $10.6 million for the year ended 2022, as compared to $37.0 million for the fourth quarter and year ended 2021.
  • The increase was the result of the completion of the Company’s follow-on public offering in August 2022.

Cerevel Therapeutics Announces Publication in The Lancet of Emraclidine Data from Phase 1b Clinical Trial in People Living with Schizophrenia

Retrieved on: 
Thursday, December 15, 2022

CAMBRIDGE, Mass., Dec. 15, 2022 (GLOBE NEWSWIRE) -- Cerevel Therapeutics (Nasdaq: CERE), a company dedicated to unraveling the mysteries of the brain to treat neuroscience diseases, announced today the publication of data from its Phase 1b clinical trial of emraclidine, a novel muscarinic M4 selective positive allosteric modulator, in adults living with schizophrenia in The Lancet.

Key Points: 
  • Recently, in order to accelerate a potentially registrational package for emraclidine in schizophrenia, the company also initiated EMPOWER-3, a 52-week open-label safety extension trial.
  • This two-part, phase 1b trial was designed to assess the safety and tolerability of emraclidine in people living with schizophrenia.
  • The first part of the trial (part A) was a multiple ascending-dose design to establish safety, tolerability, and appropriate dosing based on pharmacokinetics.
  • Current pharmacologic treatments for schizophrenia primarily target excessive striatal dopaminergic signaling by directly antagonizing postsynaptic dopamine D2 receptor subtypes.

Reviva Pharmaceuticals Announces Positive Safety Data from Drug-Drug Interaction Clinical Study of Brilaroxazine

Retrieved on: 
Thursday, December 15, 2022

CUPERTINO, Calif., Dec. 15, 2022 (GLOBE NEWSWIRE) -- Reviva Pharmaceuticals Holdings, Inc. (NASDAQ: RVPH) (“Reviva” or the “Company”), a clinical-stage pharmaceutical company developing therapies that seek to address unmet medical needs in the areas of central nervous system (CNS), cardiovascular, metabolic, and inflammatory diseases, today announced positive data from its recently completed clinical drug-drug interaction (DDI) study investigating the potential effect of CYP3A4 enzyme on brilaroxazine in healthy subjects. The CYP3A4 enzyme plays a pivotal role in helping the body metabolize and remove small foreign molecules and is primarily found in the liver and intestine. DDI evaluation is a critical clinical pharmacology study required by the U.S. Food and Drug Administration (FDA) and other regulatory agencies globally for approving a new drug to market. Brilaroxazine is a serotonin/dopamine modulator in late-stage clinical development for the treatment of schizophrenia.

Key Points: 

    Sosei Heptares’ Partner Neurocrine Biosciences Initiates Phase 2 Clinical Study Evaluating NBI-1117568 in Adults with Schizophrenia

    Retrieved on: 
    Friday, October 28, 2022

    NBI-1117568 is an investigational, muscarinic M4 selective acetylcholine receptor agonist believed to be a key regulator of neurotransmitters impacted by schizophrenia.

    Key Points: 
    • NBI-1117568 is an investigational, muscarinic M4 selective acetylcholine receptor agonist believed to be a key regulator of neurotransmitters impacted by schizophrenia.
    • The NBI-1117568 Phase 2 multi-arm, multi-stage study will enroll approximately 200 adults and is being conducted at 15 centers throughout the United States.
    • Sosei Heptares retains rights to develop M1 agonists in Japan for any indication, with Neurocrine receiving co-development and profit share options.
    • Sosei Heptares is the corporate brand and trademark of Sosei Group Corporation, which is listed on the Tokyo Stock Exchange (ticker: 4565).

    Gedeon Richter: Benzodiazepines had no additive effects to cariprazine's efficacy, neither on total symptoms, nor on hostility; cariprazine with and without benzodiazepine was significantly better than corresponding placebo in improving acute schizophreni

    Retrieved on: 
    Friday, June 10, 2022

    In the oral communication by Professor Christoph U. Correll, it was shown that benzodiazepines had no additive effects to cariprazine's efficacy, neither on total symptoms, nor on hostility.

    Key Points: 
    • In the oral communication by Professor Christoph U. Correll, it was shown that benzodiazepines had no additive effects to cariprazine's efficacy, neither on total symptoms, nor on hostility.
    • Schizophrenia is a chronic psychiatric disorder characterized by positive, negative, cognitive, and affective symptoms, affecting 1% of the population.
    • In addition, cariprazine without benzodiazepines significantly outperformed corresponding placebo in improving hostility symptoms.
    • Patients from schizophrenia and bipolar depression studies were included in the analyses investigating cariprazine's potential in improving depressive symptoms.