InnoMedica has reached an important milestone with the submission of the first Clinical Trial Application for Talineuren to Swissmedic for the treatment of Parkinson’s disease. The application is over 1,300 pages long. It documents in detail the results from the preclinical studies, includes a scientific review of empirical values on Talineuren’s active substance GM1 in humans and details relevant information on manufacturing and quality assurance. Furthermore, the study conduct is described in detail.
The study will include 12 patients with Parkinson’s disease. A stepwise dose escalation will be performed with the first three patients over a course of 14 weeks. This will enable dose determination. Nine further patients will subsequently be treated with Talineuren at the determined dose for a period of eight weeks. The leading neurologist PD Dr. med. Michael Schüpbach will be responsible for the recruitment and care of the patients. Mr. Schüpbach already supported InnoMedica in the study planning of Talineuren. This first clinical trial has two core aims: Demonstrating the safety of Talineuren and collecting initial data on its efficacy. Once the dose and administration regimen have been determined, the study will be expanded by including a larger number of patients as well as additional treatment centers.
A response from Swissmedic to the study application is expected within one to two months. Accordingly, treatment of the first Parkinson’s patients can most likely begin by the second half of 2021. In addition, a study application for the treatment of patients with amyotrophic lateral sclerosis (ALS) shall also be submitted, as soon as the optimal dose for treatment with Talineuren has been determined. At the beginning of this year, Talineuren has already received orphan drug status from the authorities in Europe (EMA) and the US (FDA) for the treatment of this rare and hitherto incurable disease. Orphan drug status guarantees market exclusivity in the event of approval.