ECNP

ORYZON Announces Last Patient Last Visit in its Phase IIb PORTICO Study for Borderline Personality Disorder (BPD)

Retrieved on: 
Tuesday, November 7, 2023
ORY, Genomics, Aggression, DMC, ISIN, CNS, Data monitoring committee, EudraCT, Disease, ECNP, Safety, Agitation, BPD, Interim analysis, Patient, Borderline personality disorder, Pharmaceutical industry, Medical device

: 2020-003469-20, ClinicalTrials.gov Identifier NCT04932291) is a global double-blind, randomized, placebo-controlled, adaptive 14-week Phase IIb trial evaluating the efficacy and safety of vafidemstat in a BPD population.

Key Points: 
  • : 2020-003469-20, ClinicalTrials.gov Identifier NCT04932291) is a global double-blind, randomized, placebo-controlled, adaptive 14-week Phase IIb trial evaluating the efficacy and safety of vafidemstat in a BPD population.
  • The trial has two primary endpoints: reduction of agitation and aggression and overall disease improvement in BPD severity.
  • The independent Data Monitoring Committee (DMC) has met routinely and reviewed unblinded safety data throughout the PORTICO trial.
  • Our quest on the primary endpoints is replicated in a rich set of secondary endpoints, making PORTICO a very informative trial.

ORYZON Reports Financial Results and Corporate Updates for Quarter Ended September 30, 2023

Retrieved on: 
Friday, October 27, 2023
Research, ORY, Fruit, DMC, Food, Deficit spending, Risk, Medicine, ECNP, Schizophrenia, Platinum, ICMJE recommendations, SCLC, Charcot–Marie–Tooth disease, Sciatic nerve, Psychotherapy, Paclitaxel, NET, FCCC, MRD, Safety, EVOLUTION, BPD, Kabuki syndrome, Patient, Borderline personality disorder, ALS, Fox Chase Cancer Center, Genomics, Human, Duration, Glomus tumor, Measure (mathematics), Clinical trial, Dor, DSM-IV codes, Animal, European College of Neuropsychopharmacology, LSD1, FMS, CMT, FDA, IND, Innovation, ISIN, CNS, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, R, HOPE, AML, Failure, Medical device, Pharmaceutical industry, Nursing, Cryptocurrency, EU, Science

Dr Carlos Buesa, Oryzon’s Chief Executive Officer, said: “Oryzon continued with a strong path in its clinical programs in the third quarter.

Key Points: 
  • Dr Carlos Buesa, Oryzon’s Chief Executive Officer, said: “Oryzon continued with a strong path in its clinical programs in the third quarter.
  • The company has started a structured dialogue with corporate pharma to identify a suitable partner to move forward the asset to Phase III, pending positive results.
  • General and administrative expenses were $0.7 and $2.9 million for the quarter and nine months ended September 30, 2023, respectively, compared to $0.7 and $3.3 million for the quarter and nine months ended September 30, 2022.
  • Net losses were $0.8 and $3.4 million for the quarter and nine months ended September 30, 2023, respectively, compared to $0.7 and $3.9 million for the quarter and nine months ended September 30, 2022.

Karuna Therapeutics Reports Third Quarter 2023 Financial Results and Provides General Business Updates

Retrieved on: 
Thursday, November 2, 2023
Biotechnology, FDA, Health, Pharmaceutical, Clinical Trials, KRTX, Psychiatry, Psychosis, Congress, ECNP, Schizophrenia, European College of Neuropsychopharmacology, NDA, Therapy, Patient, Cognition, Pharmaceutical industry, KarXT, PANSS

Karuna Therapeutics, Inc. (NASDAQ: KRTX), a biopharmaceutical company driven to discover, develop, and deliver transformative medicines for people living with psychiatric and neurological conditions, today announced financial results for the third quarter of 2023 and provided a general business update.

Key Points: 
  • Karuna Therapeutics, Inc. (NASDAQ: KRTX), a biopharmaceutical company driven to discover, develop, and deliver transformative medicines for people living with psychiatric and neurological conditions, today announced financial results for the third quarter of 2023 and provided a general business update.
  • Submitted an NDA to the FDA for KarXT for the treatment of schizophrenia in adults in the third quarter of 2023.
  • General and administrative expenses were $32.3 million for the third quarter of 2023, as compared to $19.1 million for the prior year period.
  • The third quarter 2023 financial results and business update will be discussed during a conference call and webcast today at 8:00 a.m.

MindMed Reports Third Quarter 2023 Financial Results and Business Highlights

Retrieved on: 
Thursday, November 2, 2023
Biotechnology, Neurology, Other Health, Health, Clinical Trials, Week, Spectrum, AISRS, Congress, Prevalence, G&A, Telephone, Finance, University Hospital of Basel, Volunteering, Research, Pharmacokinetics, Growth, Attention deficit hyperactivity disorder predominantly inattentive, Clinical trial, Medicine, ECNP, Webcast, Research and development, Anticipation, European College of Neuropsychopharmacology, USD, GAD, NEO, UHB, ASD, MindMed, Patient, Administration, ADHD, Pharmaceutical industry, Birth control, Dietary supplement, Vaccine, Cryptocurrency, R

Mind Medicine (MindMed) Inc. (NASDAQ: MNMD), (NEO: MMED), (the “Company” or “MindMed”), a clinical stage biopharmaceutical company developing novel product candidates to treat brain health disorders, today reported its financial results for the quarter ended September 30, 2023.

Key Points: 
  • Mind Medicine (MindMed) Inc. (NASDAQ: MNMD), (NEO: MMED), (the “Company” or “MindMed”), a clinical stage biopharmaceutical company developing novel product candidates to treat brain health disorders, today reported its financial results for the quarter ended September 30, 2023.
  • Dosing is complete with topline results for the primary endpoint (Week 4) expected to be announced in Q4 2023.
  • R&D expenses were $13.2 million for the quarter ended September 30, 2023, compared to $7.8 million for the quarter ended September 30, 2022, an increase of $5.4 million.
  • MindMed management will host a conference call at 4:30 PM EST today to provide a corporate update and review the Company’s third quarter 2023 financial results.

Gedeon Richter: an effective treatment for female schizophrenia patients

Retrieved on: 
Wednesday, October 18, 2023
Cariprazine, Hallucination, Scott Richter, Physician, Asociality, Observational study, Alogia, Patient, ECNP, Gideon, Delusion, Anhedonia, European College of Neuropsychopharmacology, Risperidone, Woman, Pharmaceutical industry, Schizophrenia

Cariprazine was found to be effective in women with schizophrenia in a real-life setting with around 70% of the physicians being satisfied with the results.

Key Points: 
  • Cariprazine was found to be effective in women with schizophrenia in a real-life setting with around 70% of the physicians being satisfied with the results.
  • Schizophrenia is a chronic psychiatric disorder characterized by positive, negative, cognitive, and mood symptoms, affecting about 1% of the population.
  • Although antipsychotics are effective in the treatment of positive symptoms, the management of negative, cognitive, and affective symptoms often remains challenging.
  • Treatment with risperidone is still one of the most used standards when it comes to schizophrenia.

ORYZON presents blinded aggregate safety data from vafidemstat’s ongoing Phase IIb PORTICO trial in Borderline Personality Disorder

Retrieved on: 
Tuesday, October 10, 2023
Congress, Aggression, European College of Neuropsychopharmacology, BPD, ORY, Safety, Psychotherapy, Borderline personality disorder, Genomics, Agitation, Clinical trial, ISIN, CNS, EudraCT, ECNP, Patient, Pharmaceutical industry

Oryzon presented a poster communication entitled “PORTICO – Double-blind, randomized placebo-controlled, adaptive phase IIb trial with vafidemstat in borderline personality disorder – aggregated baseline characteristics, demographics and safety”, which was presented by Dr. Michael Ropacki, Oryzon’s CMO for CNS.

Key Points: 
  • Oryzon presented a poster communication entitled “PORTICO – Double-blind, randomized placebo-controlled, adaptive phase IIb trial with vafidemstat in borderline personality disorder – aggregated baseline characteristics, demographics and safety”, which was presented by Dr. Michael Ropacki, Oryzon’s CMO for CNS.
  • The data presented at ECNP-2023 correspond to the analysis of aggregated blinded safety data cut as of August 23, 2023.
  • As of September 2023, PORTICO randomized 210 participants, and 131 of the originally planned participants (N = 150) already completed the trial.
  • : 2020-003469-20, ClinicalTrials.gov Identifier NCT04932291) is a global double blind, randomized, placebo-controlled, adaptive 14-week Phase IIb trial evaluating the efficacy and safety of vafidemstat in a BPD population.

EQS-News: Newron TRS study 6 months’ results: Evenamide substantially improves patients to an extent that they no longer meet protocol entry criteria

Retrieved on: 
Tuesday, October 17, 2023
Incidence, Schizophrenia, LOF, Clinical Global Impression, PANSS, Safety, CEST, Positive, Evenamide, TRS, Strauss, CNS, Peripheral nervous system, Psychosis, Level, XETRA, ECNP, Patient, Pharmaceutical industry, Nursing, Functional neurologic disorder

Newron TRS study 6 months’ results: Evenamide substantially improves patients to an extent that they no longer meet protocol entry criteria

Key Points: 
  • Newron TRS study 6 months’ results: Evenamide substantially improves patients to an extent that they no longer meet protocol entry criteria
    The issuer is solely responsible for the content of this announcement.
  • 95% of patients completed six weeks of treatment, 94% of the completers chose to continue with evenamide treatment into the long-term extension study (Study 015) and 92% of them reached six months of treatment.
  • In contrast to common clinical experience, no patients experienced worsening of their psychoses; consequently, no patients relapsed.
  • Review of the efficacy data indicated that treatment with evenamide resulted in approximately 40% of patients, at six months, no longer meeting the protocol severity criteria used to diagnose treatment resistance.

Newron TRS Study 6 Months’ Results: Evenamide Substantially Improves Patients to an Extent That They No Longer Meet Protocol Entry Criteria

Retrieved on: 
Monday, October 9, 2023
Science, Neurology, Biotechnology, Research, Pharmaceutical, General Health, Health, Clinical Trials, Incidence, Schizophrenia, LOF, Clinical Global Impression, PANSS, Safety, CEST, Positive, TRS, Strauss, Medication, CNS, Peripheral nervous system, Psychosis, XETRA, ECNP, Patient, Pharmaceutical industry, Nursing

95% of patients completed six weeks of treatment, 94% of the completers chose to continue with evenamide treatment into the long-term extension study (Study 015) and 92% of them reached six months of treatment.

Key Points: 
  • 95% of patients completed six weeks of treatment, 94% of the completers chose to continue with evenamide treatment into the long-term extension study (Study 015) and 92% of them reached six months of treatment.
  • In contrast to common clinical experience, no patients experienced worsening of their psychoses; consequently, no patients relapsed.
  • Review of the efficacy data indicated that treatment with evenamide resulted in approximately 40% of patients, at six months, no longer meeting the protocol severity criteria used to diagnose treatment resistance.
  • These results have expedited the design of a potentially pivotal, Phase III randomized, double-blind, placebo-controlled study of two doses of evenamide (15 and 30 mg bid) as an add-on treatment in patients with TRS.

Cumulus Neuroscience Presents Data at ECNP 2023 Annual Meeting

Retrieved on: 
Tuesday, October 10, 2023
TMS, Doctor of Philosophy, Neuropsychiatry, European College of Neuropsychopharmacology, Memory, Health, EEG, FDA, Data collection, MRI, Learning, LTP, CNS, ECNP, Patient, Medical imaging, Cumulus cloud

At-home pilot study confirmed real-world feasibility of low burden, remote measurement of neuroplasticity

Key Points: 
  • At-home pilot study confirmed real-world feasibility of low burden, remote measurement of neuroplasticity
    BELFAST, Ireland and CAMBRIDGE, Mass., Oct. 10, 2023 /PRNewswire/ -- Cumulus Neuroscience (Cumulus; The Company), a global digital health company focused on advancing neuroscience clinical trials and patient care through improved data, presented data from a feasibility pilot study at the European College of Neuropsychopharmacology (ECNP) Annual Meeting in Barcelona, Spain on October 10th.
  • Using the proprietary Cumulus Neuroassessment Platform to gather data via repeated at-home sampling, the study was conducted on behalf of a biopharma study sponsor.
  • LTP is a synaptic plasticity phenomenon related to learning and memory which is used widely in animal studies.
  • Cumulus supports precision in CNS clinical trials for its industry partners by enabling remote monitoring of patients across multiple domains of brain function.

Cumulus Neuroscience Presents Data at ECNP 2023 Annual Meeting

Retrieved on: 
Tuesday, October 10, 2023
TMS, Doctor of Philosophy, Neuropsychiatry, European College of Neuropsychopharmacology, Memory, Health, EEG, FDA, Data collection, MRI, Learning, LTP, CNS, ECNP, Patient, Medical imaging, Cumulus cloud

At-home pilot study confirmed real-world feasibility of low burden, remote measurement of neuroplasticity

Key Points: 
  • At-home pilot study confirmed real-world feasibility of low burden, remote measurement of neuroplasticity
    BELFAST, Ireland and CAMBRIDGE, Mass., Oct. 10, 2023 /PRNewswire/ -- Cumulus Neuroscience (Cumulus; The Company), a global digital health company focused on advancing neuroscience clinical trials and patient care through improved data, presented data from a feasibility pilot study at the European College of Neuropsychopharmacology (ECNP) Annual Meeting in Barcelona, Spain on October 10th.
  • Using the proprietary Cumulus Neuroassessment Platform to gather data via repeated at-home sampling, the study was conducted on behalf of a biopharma study sponsor.
  • LTP is a synaptic plasticity phenomenon related to learning and memory which is used widely in animal studies.
  • Cumulus supports precision in CNS clinical trials for its industry partners by enabling remote monitoring of patients across multiple domains of brain function.