Clinical study with Talineuren for the treatment of Parkinson's disease.

Zusammenfassung der Studie

NEON is a clinical study aimed at investigating the safety of Talineuren in patients with Parkinson's disease at a study center in the canton of Bern. Typically, patients with Parkinson's are treated with dopamine/levodopa medications to counteract the dopamine deficiency caused by the disease. In our research project, we want to find out whether the additional therapy with Talineuren is well tolerated and whether an effect can be measured. Talineuren contains the active ingredient GM1 (Monosialotetrahexosylganglioside), which is already on the market in other countries and is administered either intramuscularly or intravenously. InnoMedica produces GM1 in a new formulation called Talineuren, in which the active ingredient is encapsulated in very small lipid spheres at the nanometer scale. The active ingredient GM1 has shown good tolerability in other applications and has properties that protect nerve cells. Affected patients should be able to benefit as soon as possible. In patients with Parkinson's, the naturally occurring GM1 in the brain is reduced, which is why we conduct the NEON study in diseased individuals and not in healthy ones. Thus, in addition to collecting data on the safety and tolerability of Talineuren, data relevant for the efficacy assessment can already be collected. With this clinical study, we want to investigate in a first phase, where the dose is continuously increased (3 patients, so-called dose escalation), and in a second phase where a well-tolerated dose is administered multiple times (9 patients, so-called dose consolidation), how well tolerated Talineuren is and whether the first effects of efficacy can already be measured.

(BASEC)

Untersuchte Intervention

Part 1 of the study: gradual dose increase (dose escalation) in 3 patients until the maximum tolerable dose is reached or until intolerable side effects occur. The first dose is set very low at 6 mg of Talineuren. The increase occurs to 12 mg and 60 mg. From there, dose increments of 60 mg are made, up to a maximum of 720 mg. The maximum duration of Talineuren administration is 14 weeks.

Part 2 of the study: repeated administration of the same dose (dose consolidation) in 9 patients with the maximum tolerable dose determined in part 1 for 8 weeks.

In both parts, study participants receive Talineuren once a week as an infusion lasting about 1 hour.

Optional further treatment 1: patients from dose escalation have the opportunity for an 8-week further treatment with the study medication (720 mg/week).

Optional further treatment 2: all patients have the opportunity for a 16-week further treatment with the study medication (720 mg/week).

Optional further treatment 3:

- All previously enrolled study patients have the opportunity for an 8-month further treatment with the study medication (720 mg/week).

- 10 new patients will be enrolled in the study and treated for 8 months with the study medication (720 mg/week).

Optional further treatment 4:

- Study patients from parts I and II have the opportunity for a 4-month further treatment with the study medication (720 mg/week).

Optional further treatment 5:

- Study patients from parts I and II have the opportunity for a 12-month further treatment with the study medication (720 mg/week).

(BASEC)

Untersuchte Krankheit(en)

Confirmed Parkinson's disease according to British Brain Bank criteria, disease stage according to Hoehn and Yahr 0 – 2.5, with Parkinson's medications.

(BASEC)

Sponsor

InnoMedica Schweiz AG

(BASEC)

Name der bewilligenden Ethikkommission (bei multizentrischen Studien nur die Leitkommission)

Ethikkommission Bern

(BASEC)

Datum der Bewilligung durch die Ethikkommission

11.10.2021

(BASEC)

Ergebnisse der Studie