CVN766 / Cerevance - LARVOL DELTA

Cerevance Announces Publication of CVN766 in Bioorganic & Medicinal Chemistry Letters (GlobeNewswire) - "Cerevance...today announced a publication describing the discovery and initial development of CVN766 in the peer-reviewed journal, Bioorganic & Medicinal Chemistry Letters. In the publication...the authors describe the development of CVN766 to be over 1,000-fold more selective for the orexin 1 receptor (Ox1R) than the orexin 2 receptor (Ox2R). This selectivity avoids causing somnolence and sleep that is regulated by Ox2R."

Preclinical • CNS Disorders

Discovery and first-time disclosure of CVN766, an exquisitely selective orexin 1 receptor antagonist. (PubMed, Bioorg Med Chem Lett) - "In agreement with its in vitro ADME data, CVN766 demonstrated moderate in vivo clearance in rodents and displayed good brain permeability and target occupancy. This drug candidate is currently being investigated in clinical trials for schizophrenia and related psychiatric conditions."

Journal • CNS Disorders • Mental Retardation • Psychiatry • Schizophrenia • Sleep Disorder

CVN766 – Selective Ox1R antagonist shows efficacy in pre-clinical models of schizophrenia (ECNP 2023) - "The plasma concentration achieved with 0.3 mg/kg equated to a receptor occupancy of approximately 25%. Conclusion CVN766, via inhibition of Ox1R, improves behavioural effects in pre-clinical models of schizophrenia and offers a novel therapeutic approach to treating schizophrenia, particularly the negative and cognitive symptoms."

Preclinical • CNS Disorders • Mood Disorders • Psychiatry • Schizophrenia

Cerevance Announces Oral Presentation of Phase 1 Data on CVN766 at American Society of Clinical Psychopharmacology (ASCP) (GlobeNewswire) - P1 | N=64 | NCT05105243 | Sponsor: Cerevance | "Cerevance...today announced plans to present an oral presentation at the upcoming American Society of Clinical Psychopharmacology (ASCP) conference, taking place in Miami, Florida, May 30 – June 2, 2023. 'We are very excited to present the Phase 1 CVN766 data for the first time at a medical conference,' said Craig Thompson, chief executive officer of Cerevance. 'The favorable safety and tolerability profile coupled with lack of somnolence supports the potential of CVN766 to become an impactful treatment to address the unmet need of negative and cognitive symptoms in patients with schizophrenia.'"

P1 data • CNS Disorders • Psychiatry • Schizophrenia

A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Safety, Tolerability, and Pharmacokinetic Study of Escalating Single and Multiple Doses of CVN766, an OX1R Highly Selective Antagonist in Healthy Subjects (ASCP 2023) - "Based on the predicted receptor occupancy (RO), we expect doses 45 mg to 250 mg to reach RO between approximately 85% and 97%, which, based on the animal modes, should be more likely efficacious. Given its mechanism of action and the functions of orexin A, it is possible that CVN766 could also improve aspects of the metabolic syndrome caused by antipsychotics, thus further contributing to an improvement in morbidity and quality of life for individuals suffering from schizophrenia."

Clinical • P1 data • PK/PD data • CNS Disorders • Psychiatry • Schizophrenia

A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Safety, Tolerability, and Pharmacokinetic Study of Escalating Single and Multiple Doses of CVN766, an OX1R Highly Selective Antagonist in Healthy Subjects (ASCP 2023) - "Based on the predicted receptor occupancy (RO), we expect doses 45 mg to 250 mg to reach RO between approximately 85% and 97%, which, based on the animal modes, should be more likely efficacious. Given its mechanism of action and the functions of orexin A, it is possible that CVN766 could also improve aspects of the metabolic syndrome caused by antipsychotics, thus further contributing to an improvement in morbidity and quality of life for individuals suffering from schizophrenia."

Clinical • P1 data • PK/PD data • CNS Disorders • Psychiatry • Schizophrenia

Phase 1 SAD/MAD Study of CVN766 in Healthy Volunteers (clinicaltrials.gov) - P1 | N=64 | Completed | Sponsor: Cerevance | Recruiting ➔ Completed

Trial completion

Phase 1 SAD/MAD Study of CVN766 in Healthy Volunteers (clinicaltrials.gov) - P1 | N=64 | Recruiting | Sponsor: Cerevance | Not yet recruiting ➔ Recruiting | Trial primary completion date: Jul 2022 ➔ Oct 2022

Enrollment open • Trial primary completion date