January in Review: Updates on the Psychiatric Treatment Pipeline

January saw some important developments in the psychiatric treatment pipeline. We compiled a recap of the latest news here, just in case you missed any of the updates.

Navacaprant for Major Depressive Disorder Fails in Late-Stage Study

The oral kappa opioid receptor antagonist navacaprant for the treatment of major depressive disorder failed in a phase 3 study as part of Neumora Therapeutics' pivotal KOASTAL program. Both navacaprant and placebo showed similar improvements in depression scores, with no significant difference. Women showed a slightly better response to navacaprant compared to placebo, warranting further investigation.

LB-102 for Schizophrenia Sees Positive Phase 2 Topline Results

LB Pharmaceuticals announced positive topline results from NOVA1, a phase 2 dose finding trial evaluating N-methyl amisulpride (LB-102), a once-daily orally administered novel dopamine D_2/3/5-HT₇ inhibitor and potential first-in-class benzamide antipsychotic, in adult patients with acute schizophrenia. LB-102 demonstrated significant efficacy in reducing PANSS scores in acute schizophrenia, with varying effect sizes across doses. The safety profile of LB-102 was favorable, showing low incidence of extrapyramidal symptoms and minimal adverse effects.

FDA Grants Fast Track Designation to Posdinemab for Early Alzheimer Disease

The US Food and Drug Administration granted Fast Track designation to posdinemab, a phosphorylated tau-directed monoclonal antibody being investigated for the treatment of patients with early Alzheimer disease in the phase 2b AuTonomy study. Posdinemab's unique binding to the mid-domain of tau differentiates it from other anti-tau antibodies, potentially enhancing its effectiveness.

FDA Grants Breakthrough Device Designation to pTau 217 Blood Test for Alzheimer Disease

The US Food and Drug Administration granted Breakthrough Device Designation to Spear Bio’s pTau 217 blood test for Alzheimer disease. The pTau 217 blood test offers a noninvasive alternative for Alzheimer's diagnosis, distinguishing it from other neurodegenerative disorders. Spear Bio's SPEAR technology enhances diagnostic accuracy by minimizing nonspecific interactions, allowing for precise biomarker measurements.

FDA Accepts Biologics License Application for Lecanemab-irmb

The US Food and Drug Administration accepted Eisai's Biologics License Application for lecanemab-irmb (Leqembi) subcutaneous autoinjector for weekly maintenance dosing. Lecanemab-irmb subcutaneous autoinjector offers a home-administered Alzheimer's treatment, potentially reducing hospital visits and simplifying care. The Clarity study demonstrated a 14% increase in amyloid plaque removal with subcutaneous administration compared to IV.

Esketamine CIII Nasal Spray: First and Only Monotherapy for Treatment-Resistant Depression

The US Food and Drug Administration has approved the Johnson & Johnson supplemental New Drug Application for esketamine (Spravato) CIII nasal spray, the first and only monotherapy for adults with treatment-resistant depression, defined as inadequate response to at least 2 oral antidepressants. Spravato reduces symptoms of depression in as little as 24 hours and reduces the time to relapse for patients who stay on treatment. The approval is based on a study showing significant improvement in depression scores compared with placebo, with a consistent safety profile.

Phase 3 Study Initiated: Osavampator as Adjunctive Therapy for Major Depressive Disorder

Neurocrine Biosciences just announced the initiation of a phase 3 registrational study to evaluate the efficacy, safety, and tolerability of osavampator, an investigational drug under development as an adjunctive treatment to antidepressants for major depressive disorder. Investigators will enroll adults with a primary diagnosis of major depressive disorder who have inadequate response to current, oral antidepressant treatment.

BPL-003 for Alcohol Use Disorder: Positive Topline Results of Phase 2A Study

Beckley Psytech today announced positive topline results from their open-label phase 2A study of BPL-003 in participants with moderate-to-severe alcohol use disorder, which show that treatment with BPL-003 can induce meaningful and sustained reductions in alcohol use and heavy drinking days for up to 3 months following a single dose. BPL-003 significantly reduced alcohol consumption and increased abstinence in participants with moderate-to-severe alcohol use disorder over a 12-week period.

AD04 for Alcohol Use Disorder: New Positive Results From Pharmacokinetics Study

Adial Pharmaceuticals announced the completion of a pharmacokinetics study of AD04, an investigational selective serotonin-3 receptor (5-HT3) antagonist being developed for the treatment of alcohol use in patients with a 5-HT3 genomic biomarker. These study results support the near micro-dosing regimen planned for use in the upcoming registration trials for AD04 and make up the regulatory submission for the US Food and Drug Administration.

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