Expert Interview
Examining the Phase 2 Trial Results for NBI-1117568 in Schizophrenia from Neurocrine Biosciences (NBIX) and Nxera Pharma
Ticker(s): NBIX, Nxera PharmaInstitution: Northwell Health
- Professor of psychiatry and molecular medicine at the Zucker School of Medicine and the co-director of the Institute for Behavioral Science at the Feinstein Institutes for Medical Research.
- Recipient of many awards, including the Lieber Prize, the APA’s Kempf Award and Foundations Prize, the New York State Office of Mental Health Lifetime Achievement Award, and the Dean Award from the American College of Psychiatrists.
- Has served as president of the American Society of Clinical Psychopharmacology, the Psychiatry Research Society, and the Schizophrenia International Research Society.
NBI-1117568 showed a statistically significant 7.5-point improvement (p=0.011) in the PANSS total score at Week 6 compared to placebo. How meaningful is this level of improvement in the context of schizophrenia treatment, and how does it compare to other current therapies in terms of efficacy?
Added By: catalin_adminAs NBI-1117568 is the first selective M4 agonist being developed for schizophrenia, can you elaborate on the importance of M4 receptor targeting in reducing both positive and negative symptoms? What advantages might this mechanism offer over traditional antipsychotics?
Added By: catalin_adminOne of the key outcomes was that NBI-1117568 was well tolerated with minimal gastrointestinal (GI) side effects and no weight gain relative to placebo. Given the common side effects of weight gain and metabolic issues in current treatments, how significant is this safety profile for long-term schizophrenia management?
Added By: catalin_adminThe 20 mg once-daily dose met the primary endpoint, but higher doses (40 mg and 60 mg) did not show as robust an improvement. Could you explain the potential reasons behind this dose-response curve, and what considerations should be made when selecting optimal dosing for future studies?
Added By: catalin_adminSchizophrenia treatments often struggle with addressing negative symptoms effectively. NBI-1117568 demonstrated improvements in both positive and negative symptoms. What potential does this drug have in targeting negative symptoms, and how might this impact the broader treatment landscape for schizophrenia?
Added By: catalin_adminNBI-1117568 exhibited a low incidence of cardiovascular events and EPS adverse events. How important is this for patients with schizophrenia, especially considering that these side effects are often limiting factors in the use of other antipsychotic medications?
Added By: catalin_adminWith Phase 3 trials planned for early 2025, what are the key considerations in terms of patient selection, trial design, and endpoints? Do you anticipate any challenges in replicating these positive results on a larger scale?
Added By: catalin_adminNeurocrine's muscarinic portfolio includes other candidates targeting M1 and M4 receptors. How do you see the future of muscarinic therapies evolving in neuropsychiatric disorders, and what role might NBI-1117568 play in potentially reshaping schizophrenia treatment paradigms?
Added By: catalin_adminAre You Interested In These Questions?
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