Talineuren (liposomal GM1) / Innomedica, TRB Chemedica - LARVOL DELTA

Safety and tolerability of intravenous liposomal GM1 in patients with Parkinson disease: A single-center open-label clinical phase I trial (NEON trial). (PubMed, PLoS Med) - P1 | "TLN is safe and well-tolerated in general. This prospective phase I trial revealed non-allergic habituating acute infusion reactions at the second, third, or fourth treatment that can be prevented by a slower rate of infusion. Importantly, the exploratory results suggest a consistent improvement of signs and symptoms of PD."

Journal • P1 data • CNS Disorders • Depression • Dermatology • Immunology • Movement Disorders • Musculoskeletal Pain • Pain • Parkinson's Disease • Psychiatry • Urticaria

TALINEUREN IN PARKINSON'S DISEASE: PRELIMINARY RESULTS OF PHASE I TRIAL NEON (ADPD 2025) - "The consistent preliminary results on symptom amelioration and stabilization over up to >2 years treatment go in line with previous findings and highlight the potential of Talineuren for treating PD. Lastly, the hypothesized mode of action could go beyond PD therapy and mig ht be relevant for other neurodegenerative disorders."

P1 data • CNS Disorders • Movement Disorders • Parkinson's Disease

Cytoprotective effects of liposomal ganglioside GM1. (PubMed, J Liposome Res) - "More recently, the ability of exogenous GM1 to ameliorate oxidative stress was revealed, leading us to investigate the cytoprotective effect of liposomal GM1 under a variety of pathological conditions. Here we review all data showing the antioxidant effect of exogeneous GM1 and based on literature findings and our own, we propose a mechanism by which liposomal exogenous GM1 is able to trigger the Nrf2 (Nuclear factor erythroid 2-related factor 2) pathway, which is a critical cellular defense mechanism protecting against oxidative stress and other types of cellular damage."

Journal • Review

[PREPRINT] Safety and Tolerability of Intravenous Liposomal GM1 in Patients with Parkinson Disease: A Single Center Open-Label Clinical Phase I Trial (NEON Trial) (medRxiv) - P1 | N=22 | NEON (NCT04976127) | Sponsor InnoMedica Schweiz AG | "Dose escalation identified a maximum suitable weekly dose of 720 mg. Overall, 304, mostly mild adverse events occurred. Twenty-three were considered related to the study treatment. Very mild to severe acute infusion reactions at the 2nd, 3rd, or 4th administration of TLN within the first minutes of the infusion occurred in seven patients. All reported back or neck pain. Other acute infusion reactions were urticaria, plethora, nausea, and chest pain. These adverse reactions disappeared within minutes of stopping the infusion and did not recur when Talineuren administration was resumed at a very low rate....Non-motor symptoms of PD, motor parkinsonian signs off medication, and quality of life improved significantly during the treatment phase, including the MDS-UPDRS total score (mean decrease 11.09±10.47 points; p=0.006) and the PDQ-39 summary index (mean decrease 2.91±2.25 points, p =0.002)."

P1 data • PK/PD data • Preprint • CNS Disorders • Parkinson's Disease

Estimates of the Short-term Efficacy of Talineuren (TLN) and Placebo in Patients With Parkinson Disease (clinicaltrials.gov) - P2 | N=40 | Not yet recruiting | Sponsor: InnoMedica Schweiz AG

New P2 trial • CNS Disorders • Movement Disorders • Parkinson's Disease

NEON: Safety Evaluation of Intravenous Talineuren (TLN) in Parkinson's Disease-affected Patients (clinicaltrials.gov) - P1 | N=22 | Active, not recruiting | Sponsor: InnoMedica Schweiz AG | Trial completion date: Aug 2024 ➔ Aug 2025 | Trial primary completion date: Aug 2024 ➔ Aug 2025

Trial completion date • Trial primary completion date • CNS Disorders • Movement Disorders • Parkinson's Disease

NEON: Safety Evaluation of Intravenous Talineuren (TLN) in Parkinson's Disease-affected Patients (clinicaltrials.gov) - P1 | N=22 | Active, not recruiting | Sponsor: InnoMedica Schweiz AG

Trial completion date • Trial primary completion date • CNS Disorders • Movement Disorders • Parkinson's Disease

NEON: Safety Evaluation of Intravenous Talineuren (TLN) in Parkinson's Disease-affected Patients (clinicaltrials.gov) - P1 | N=22 | Active, not recruiting | Sponsor: InnoMedica Schweiz AG | Recruiting ➔ Active, not recruiting

Enrollment closed • CNS Disorders • Movement Disorders • Parkinson's Disease

NEON: Safety Evaluation of Intravenous Talineuren (TLN) in Parkinson's Disease-affected Patients (clinicaltrials.gov) - P1 | N=22 | Recruiting | Sponsor: InnoMedica Schweiz AG | N=12 ➔ 22 | Trial completion date: Dec 2022 ➔ Jun 2024 | Trial primary completion date: Dec 2022 ➔ Jun 2024

Enrollment change • Trial completion date • Trial primary completion date • CNS Disorders • Movement Disorders • Parkinson's Disease

NEON: Safety Evaluation of Intravenous Talineuren (TLN) in Parkinson's Disease-affected Patients (clinicaltrials.gov) - P1; N=12; Recruiting; Sponsor: InnoMedica Schweiz AG; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • CNS Disorders • Movement Disorders • Parkinson's Disease

NEON: Safety Evaluation of Intravenous Talineuren (TLN) in Parkinson's Disease-affected Patients (clinicaltrials.gov) - P1; N=12; Not yet recruiting; Sponsor: InnoMedica Schweiz AG; Trial completion date: Aug 2022 ➔ Nov 2022; Trial primary completion date: Aug 2022 ➔ Nov 2022

Clinical • Trial completion date • Trial primary completion date • CNS Disorders • Movement Disorders • Parkinson's Disease

NEON: Safety Evaluation of Intravenous Talineuren (TLN) in Parkinson's Disease-affected Patients (clinicaltrials.gov) - P1; N=12; Not yet recruiting; Sponsor: InnoMedica Schweiz AG

New P1 trial • CNS Disorders • Movement Disorders • Parkinson's Disease