NBI-1117568 / Nxera Pharma, Neurocrine - LARVOL DELTA

Nxera Pharma Operational Highlights and Consolidated Results for the Fourth Quarter and Full Year 2024 (GlobeNewswire) - "NBI-1117568 (an oral, muscarinic M4-selective agonist): End of Phase 2 meeting with the US Food & Drug Administration completed and reiteration of plans to begin Phase 3 studies in schizophrenia in 1H 2025. Initiate Phase 2 study in bipolar mania in 2H 2025....NBI-1117570 (a dual M1 / M4 agonist): Initiate Phase 2 study in schizophrenia in 2H 2025....NBI-1117567 (an M1-preferring agonist) and NBI-1117569 (an M4-preferring agonist): Phase 1 trials underway targeting neurological and neuropsychiatric conditions with data readouts anticipated during 2025."

FDA event • New P2 trial • New P3 trial • P1 data • Bipolar Disorder • CNS Disorders • Schizophrenia

NBI-1117568-SCZ2028: Efficacy, Safety, Tolerability, and Pharmacokinetics of NBI-1117568 in Adults With Schizophrenia (clinicaltrials.gov) - P2 | N=210 | Completed | Sponsor: Neurocrine Biosciences | Recruiting ➔ Completed | Trial completion date: Dec 2024 ➔ Jul 2024

Trial completion • Trial completion date • CNS Disorders • Psychiatry • Schizophrenia

Neurocrine Biosciences Provides Update on ERUDITE Phase 2 Data for Luvadaxistat in Adults with Cognitive Impairment Associated with Schizophrenia (PRNewswire) - P2 | N=216 | ERUDITE (NCT05182476) | Sponsor: Neurocrine Biosciences | "Neurocrine Biosciences, Inc...today announced that its ERUDITE Phase 2 clinical study of investigational compound luvadaxistat (NBI-1065844) failed to meet its primary endpoint as a potential treatment to improve cognitive impairment in patients with schizophrenia....The ERUDITE study was the second Phase 2 trial for luvadaxistat. It failed to replicate the cognitive endpoints data seen in the earlier INTERACT study, due in part to the large variability seen in the cognitive measures across the population studied and a potential imbalance in the baseline characteristics of subjects enrolled across the treatment arms....We therefore plan to halt further development of luvadaxistat at this time and instead will focus our efforts and resources on the advancement into Phase 3 clinical development of NBI-1117568 for schizophrenia and NBI-1065845 for major depressive disorder."

New P3 trial • P2 data • Major Depressive Disorder • Schizophrenia

Nxera Pharma to Receive US$35 Million from Neurocrine Biosciences upon Positive Phase 2 Data for Partnered Schizophrenia Candidate NBI-1117568 (GlobeNewswire) - "Nxera Pharma...announces that it will receive a US$35 million payment from Neurocrine Biosciences (‘Neurocrine’), triggered by the successful completion of the Phase 2 trial with NBI-1117568 (NBI-‘568) in adults with schizophrenia, as announced on 28 August 2024. Receipt of the US$35 million payment will be recognized as one-time revenue in the third quarter of 2024. The NBI-’568-SCZ2028 dose-finding study met its primary endpoint for the once-daily 20 mg dose and was generally safe and well tolerated at all doses studied, supporting Neurocrine’s intentions to advance NBI-‘568 into Phase 3 clinical trials in early 2025."

Financing • New P3 trial • Trial status • Schizophrenia

Efficacy, Safety, Tolerability, and Pharmacokinetics of NBI-1117568 in Adults With Schizophrenia (clinicaltrials.gov) - P2 | N=213 | Recruiting | Sponsor: Neurocrine Biosciences | Not yet recruiting ➔ Recruiting

Enrollment open • CNS Disorders • Psychiatry • Schizophrenia

Efficacy, Safety, Tolerability, and Pharmacokinetics of NBI-1117568 in Adults With Schizophrenia (clinicaltrials.gov) - P2 | N=213 | Not yet recruiting | Sponsor: Neurocrine Biosciences

New P2 trial • CNS Disorders • Psychiatry • Schizophrenia

Neurocrine Biosciences and Sosei Heptares Announce Collaboration to Develop Novel Muscarinic Receptor Agonists for Schizophrenia and Other Neuropsychiatric Disorders (PRNewswire) - "Neurocrine Biosciences, Inc....and Sosei Group Corporation ('Sosei Heptares'; TSE: 4565) announce the signing of a strategic collaboration and licensing agreement to develop novel muscarinic receptor agonists, which Neurocrine Biosciences intends to study in the treatment for schizophrenia, dementia and other neuropsychiatric disorders. Under the terms of the agreement, Neurocrine Biosciences gains development and commercialization rights to a broad portfolio of novel clinical and preclinical subtype-selective muscarinic M4, M1 and dual M1/M4 receptor agonists discovered by Sosei Heptares in development for the treatment of major neurological disorders. The most advanced program, HTL-0016878, is a selective M4 agonist. Neurocrine Biosciences plans to submit an Investigational New Drug (IND) application and initiate a placebo-controlled Phase 2 study with HTL-0016878 as a potential treatment for schizophrenia in 2022."

IND • Licensing / partnership • New P2 trial • Alzheimer's Disease • CNS Disorders • Schizophrenia

Comparison of Blood Levels of HTL0016878 From an Oral Capsule and an Oral Solution (clinicaltrials.gov) - P1; N=15; Completed; Sponsor: Heptares Therapeutics Limited; Recruiting ➔ Completed

Clinical • Trial completion

Sosei Heptares Operational Highlights and Consolidated Results for the Second Quarter and First Half 2021 (PRNewswire) - "Worldwide rights to out-licensed muscarinic agonist programs regained from AbbVie/Allergan – independent review of programs has completed, with increased investment allocated to advance the HTL'878 selective muscarinic M4 receptor agonist through clinical studies and build value ahead of future partnering....Negotiations for collaborations on this and other muscarinic programs are now in progress."

Licensing / partnership • Alzheimer's Disease • CNS Disorders • Schizophrenia

Comparison of Blood Levels of HTL0016878 From an Oral Capsule and an Oral Solution (clinicaltrials.gov) - P1; N=15; Recruiting; Sponsor: Heptares Therapeutics Limited; Not yet recruiting ➔ Recruiting

Enrollment open

Comparison of Blood Levels of HTL0016878 From an Oral Capsule and an Oral Solution (clinicaltrials.gov) - P1; N=15; Not yet recruiting; Sponsor: Heptares Therapeutics Limited

Clinical • New P1 trial

Measurement of HTL0016878 in Cerebrospinal Fluid (clinicaltrials.gov) - P1; N=16; Completed; Sponsor: Heptares Therapeutics Limited

New P1 trial

Sosei Heptares Operational Highlights and Consolidated Results for the 12 Months ended 31 December 2020 (PRNewswire) - "Worldwide rights to out-licensed muscarinic agonist programs regained from AbbVie/Allergan – independent review of programs has completed, with increased investment allocated to advance the HTL0016878 selective muscarinic M4 agonist through clinical studies...HTL0016878 represents a unique opportunity to develop a novel therapeutic with a new mechanism of action for neurological disorders including schizophrenia. Negotiations for collaborations on this and other muscarinic programs are now in progress."

Licensing / partnership • CNS Disorders • Schizophrenia

Sosei Heptares to Regain Worldwide Rights to Muscarinic Agonist Programs (PRNewswire) - "Sosei Group Corporation...announces it is to regain the worldwide rights to its muscarinic agonist programs. The program was licensed to Allergan in April 2016, and Allergan was acquired by AbbVie in May 2020. This decision to return worldwide rights was based on business decisions regarding AbbVie’s pipeline strategy and not on any efficacy, safety or other data related to the collaboration programs....Sosei Heptares will now conduct a full internal review to determine a strategy for the further development and re-partnering of the program."

Licensing / partnership • Alzheimer's Disease • CNS Disorders • Schizophrenia

A Two Part Study to Assess Safety, PK, PD, and Food Effect of Oral HTL0016878 (clinicaltrials.gov) - P1; N=120; Completed; Sponsor: Heptares Therapeutics Limited; Recruiting ➔ Completed

Clinical • Trial completion

A Two Part Study to Assess Safety, PK, PD, and Food Effect of Oral HTL0016878 (clinicaltrials.gov) - P1; N=106; Recruiting; Sponsor: Heptares Therapeutics Limited; Trial completion date: Sep 2018 ➔ Sep 2019; Trial primary completion date: Sep 2018 ➔ Sep 2019

Clinical • Trial completion date • Trial primary completion date