gemlapodect (NOE-105) / Roche, Noema Pharma - LARVOL DELTA

Exploratory analysis of the relationship between striatal connectivity and apathy during phosphodiesterase 10 inhibition in schizophrenia: findings from a randomized crossover trial. (PubMed, BMC Med) - P1 | "These findings suggest that striatal connectivity with the paracingulate gyrus and anterior cingulate cortex may be associated with apathy modulation under RG7203 treatment. Replication and further elaboration of these findings in larger clinical studies could help to advance biologically informed and personalized treatment options for negative symptoms."

Clinical • Journal • CNS Disorders • Psychiatry • Schizophrenia

Emerging therapeutic approaches for Tourette syndrome and other tic disorders - a systematic review of current clinical trials. (PubMed, Eur Child Adolesc Psychiatry) - "Potential candidates include the dopamine D1 antagonist ecopipam, the phosphodiesterase inhibitor gemlapodect, and cannabis-based therapies. Despite the range of research activities underway, the overall landscape remains limited. In this report we will discuss the findings, current developments, and relevant aspects concerning future research including clinical, scientific, and patient perspectives."

Journal • Review • CNS Disorders • Developmental Disorders • Movement Disorders • Psychiatry • Tic Disorders • Tourette Syndrome • Transplantation

Results of ALLEVIA 1 (NOE-TTS-211; EudraCT 2021-004424-15; ANZCTR ACTRN12621000319875), a Phase 2a study exploring safety and tolerability of NOE-105 in patients with Tourette Syndrome (MDS Congress 2024) - P2 | "A total of 15 patients (13 adults, 2 adolescents) were enrolled in the study. The summary of the study results will be added by the 15 Aug 2024."

Clinical • Late-breaking abstract • P2a data • ADHD (Impulsive Aggression) • Attention Deficit Hyperactivity Disorder • CNS Disorders • Depression • Mood Disorders • Obsessive-Compulsive Disorder • Psychiatry • Tourette Syndrome

Allevia2: Efficacy and Safety of Gemlapodect in Adults and Adolescents With Tourette Syndrome (clinicaltrials.gov) - P2 | N=180 | Recruiting | Sponsor: Noema Pharma AG | Not yet recruiting ➔ Recruiting | Initiation date: May 2024 ➔ Sep 2024

Enrollment open • Trial initiation date • Movement Disorders • Tourette Syndrome

An open-label, Phase IIa, multi-center, 12-week prospective study to evaluate the safety and efficacy of NOE-105 at a daily dose range of 2.5mg to 15mg in adult and adolescent male patients with Tourette Syndrome (TS). (ANZCTR) - P2 | N=18 | Completed | Sponsor: Noema Pharma Australia Pty Ltd | Recruiting ➔ Completed | N=10 ➔ 18

Enrollment change • Trial completion • Movement Disorders • Tourette Syndrome

A 10-week Efficacy Study of NOE-105 in Childhood Onset Fluency Disorder (Orpheus) (clinicaltrials.gov) - P2 | N=75 | Completed | Sponsor: Noema Pharma AG | Active, not recruiting ➔ Completed

Trial completion

Allevia2: Efficacy and Safety of Gemlapodect in Adults and Adolescents With Tourette Syndrome (clinicaltrials.gov) - P2 | N=180 | Not yet recruiting | Sponsor: Noema Pharma AG

New P2 trial • Movement Disorders • Tourette Syndrome

A 10-week Efficacy Study of NOE-105 in Childhood Onset Fluency Disorder (Orpheus) (clinicaltrials.gov) - P2 | N=67 | Active, not recruiting | Sponsor: Noema Pharma AG | Phase classification: P2b ➔ P2

Phase classification

A 10-week Efficacy Study of NOE-105 in Childhood Onset Fluency Disorder (Orpheus) (clinicaltrials.gov) - P2b | N=67 | Active, not recruiting | Sponsor: Noema Pharma AG | Recruiting ➔ Active, not recruiting | Trial primary completion date: Jul 2023 ➔ Oct 2023

Enrollment closed • Trial primary completion date

A Validated Rating Scale to Accurately Determine the Treatment Effects in Childhood Onset Fluency Disorder (Stuttering)--the MLGSS. (ASCP 2023) - "A commonly used scale in stuttering assessment, the OASES, (secondary endpoint in the Ecopipam trials) although subject rated, is not reliable to measure treatment effects over time given its lengthy nature (100 questions for the adult version--subject rater fatigue.) A more compact subjective measure, the SSS, also a secondary endpoint in the above trials, yielded more reliable results than the above scales but it too is limited by several factors including that the items are unstructured and not standardized as to the time (e.g. "today's session" vs. "last week.") To overcome our unmet medical need in developing viable treatments for our stuttering community, Maguire, Leal and Garibaldi created the MLGSS (Maguire, Garibaldi, Leal Stuttering Scale), a 10 item, subject rated assessment of their own stuttering and its impact over the prior week...A further validation study of the ability of the MLGSS to measure treatment effects over time is..."

Clinical • Late-breaking abstract • CNS Disorders • Psychiatry

A 10-week Efficacy Study of NOE-105 in Childhood Onset Fluency Disorder (clinicaltrials.gov) - P2b | N=67 | Recruiting | Sponsor: Noema Pharma AG

New P2b trial

Deep Learning-Based Human Activity Recognition for Continuous Activity and Gesture Monitoring for Schizophrenia Patients With Negative Symptoms. (PubMed, Front Psychiatry) - P1 | "Data were analyzed in a randomized, three-way cross-over, proof-of-mechanism study (ClinicalTrials.gov: NCT02824055) comparing two doses of RG7203 with placebo, given as adjunct to stable antipsychotic treatment in patients with chronic schizophrenia and moderate levels of negative symptoms...Activity measures showed similar correlations with PANSS negative symptom factor but did not reach significance. Our findings support the use of wrist-worn devices to derive activity and gesture-based digital outcome measures for patients with schizophrenia with negative symptoms in a clinical trial setting."

Clinical • Journal • CNS Disorders • Psychiatry • Schizophrenia

Roche: FY 2013 Results (Roche) - Anticipated initiation of P1 trial for schizophrenia in Q1 2014

Anticipated trial initiation date • Schizophrenia