October in Review: Updates on the Psychiatric Treatment Pipeline

Take a look at this month’s developments in the psychiatric treatment pipeline. We compiled a recap of the latest news here, just in case you missed any of the updates.

BMS-986446 Granted Fast Track Designation for the Treatment of Alzheimer Disease

Bristol Myers Squibb announced that the US Food and Drug Administration (FDA) has granted Fast Track Designation to BMS-986446, a potential best-in-class anti-microtubule binding region-tau (anti-MTBR-tau) antibody in phase 2 development for the treatment of early Alzheimer disease. BMS-986446 is a humanized monoclonal antibody that targets multiple domains of the microtubule binding region of tau. In preclinical models, investigators noted that BMS-986446 demonstrated significant reductions in tau uptake and spread, protection against behavioral deficits, and was localized with tau pathology in AD brain tissue. BMS-986446 was also shown to be safe and well tolerated across 3 dose cohorts in a phase 1 study of healthy participants.

ALTO-101 Receives FDA Fast Track Designation for Treatment of Cognitive Impairment Related to Schizophrenia

Alto Neuroscience announced FDA fast track designation for ALTO-101, a transdermally administered treatment for cognitive impairment associated with schizophrenia. There are currently no FDA-approved treatments for cognitive impairment in schizophrenia. The FDA based the fast track designation on data from a phase 1 trial of the drug which found greater exposure and fewer adverse events with novel transdermal administration of ALTO-101 vs an oral PDE4 inhibitor.

Lithium-Loaded Gold Nanoparticle Nasal Spray to Treat Neuropsychiatric Diseases

Investigators discovered a new nanotechnological device for the treatment and prevention of neuropsychiatric and neurodegenerative diseases: lithium-loaded gold nanoparticles in the form of a nasal spray that delivers treatment directly to the brain. This could be a revolutionary approach to neuropsychiatric diseases such as bipolar disorder, neurodegenerative diseases such as Alzheimer disease, and brain infections such as those caused by Herpes Simplex Virus type 1. In the study, investigators demonstrated the effectiveness of this nanotechnology in inhibiting the activity of the glycogen synthase kinase-3 beta (GSK-3β) enzyme in the hippocampus and restoring memory already compromised in an experimental model of Alzheimer disease.

New ECNP Poster Data on Adjunctive Lumateperone for Major Depressive Disorder

According to data presented at the 38th European College of Neuropsychopharmacology (ECNP) Annual Congress, lumateperone, a novel antipsychotic, significantly improves symptoms of anhedonia and sexual dysfunction in patients with MDD and inadequate antidepressant therapy response. Results show that treatment with antidepressants plus lumateperone led to significant improvements in symptoms of anhedonia, sexual dysfunction, and a broad range of other depressive symptoms.

Early Dose Management and Up-Titration of Esketamine: ECNP Poster Data

In the double-blind induction phase of the randomized, active-controlled, phase 3 TRANSFORM-2 study (NCT02418585), investigators explored early dose management and up-titration from 56 to 84 mg of esketamine for treatment-resistant depression. According to the results, both esketamine nasal spray doses resulted in clinically relevant improvement in symptoms severity with no adverse effects, but some patients may benefit from early up-titration during esketamine induction.

Phase 3 Data Support CT-155 as a Novel Digital Therapeutic for Negative Symptoms in Schizophrenia at ECNP

Phase 3 data from the CONVOKE study (NCT05838625) of CT-155 demonstrated a statistically significant reduction in negative symptoms in patients with schizophrenia. Treatment via CT-155 resulted in a 6.8-point improvement on the CAINS-MAP vs 4.2 for the control arm, showing statistical significance via Cohen’s D effect size of -0.36 (P=0.0003). CT-155 also demonstrated a good safety profile with no serious adverse effects, and its design was informed by input from over 150 people living with schizophrenia.

FDA Accepts NDA for CTx-1301 for Treatment of ADHD

The FDA accepted for review the New Drug Application (NDA) for dexmethylphenidate (CTx-1301), Cingulate’s lead candidate for the treatment of attention-deficit/hyperactivity disorder (ADHD) in children and adults. CTx-1301 is a once-daily, multi-core tablet that utilizes Cingulate’s proprietary Precision Timed Release platform to deliver 3 precisely timed releases of active medication across the day, a design that aims to provide rapid onset of effect and entire active-day duration. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of May 31, 2026.

FDA Approves Uzedy Once-Monthly Extended Release Injectable Suspension for Bipolar I Disorder

Teva Pharmaceuticals announced that the FDA has approved risperidone (Uzedy) as a once-monthly extended-release injectable suspension as monotherapy or as adjunctive therapy to lithium or valproate for the maintenance treatment of adults with bipolar I disorder (BD-I). Uzedy is the first subcutaneous, long-acting formulation of risperidone that utilizes SteadyTeq technology, a copolymer technology proprietary to Medincell that controls the steady release of risperidone. Utilizing this technology, therapeutic blood concentrations are reached within 6 to 24 hours of just a single dose. For the BD-I indication, Uzedy is now approved with 3 once-monthly dosing options: 50 mg, 75 mg, and 100 mg.

New Post-Hoc Analysis: Ingrezza 40 mg Leads to Clinically Meaningful Improvements in Tardive Dyskinesia Symptoms

Neurocrine Biosciences announced the presentation of a new post-hoc analysis from the phase 3, open-label KINECT 4 study, which demonstrates that patients treated continuously for 48 weeks with the 40 mg dose of once-daily valbenazine (Ingrezza) capsules experienced clinically meaningful improvements in tardive dyskinesia (TD) symptoms. Ingrezza, a VMAT2 inhibitor, allows starting at a therapeutic dose with flexibility to adjust based on individual response and tolerability.

Positive Phase 3 Results: CTx-1301 for the Treatment of Pediatric ADHD

Cingulate Inc announced the release of positive phase 3 results from its pivotal trial of CTx-1301 (dexmethylphenidate HCl) in pediatric attention-deficit/hyperactivity disorder (ADHD), recently presented by Ann Childress, MD, at the American Academy of Child and Adolescent Psychiatry Annual Meeting in Chicago. CTx-1301 met its primary endpoint, demonstrating dose-dependent improvements on the ADHD ratings scale 5, and Clinical Global Impression-Severity scales, and demonstrated the ability to deliver symptom relief with the convenience of once-daily dosing.

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