Geneva, January 7, 2019 – TRB Chemedica and InnoMedica signed recently a letter of intent, agreeing to collaborate for the production and development of GM1 as liposomal formulation. Gangliosides are sialic acid-containing glycosphingolipids that are naturally present in the plasma membrane of most vertebrate cells, particularly in the nervous system where they constitute up to 10% of the total lipid mass in the brain. They play important roles in many physiological processes including cell differentiation, apoptosis, neuronal protection and neutrotrophins release.1 TRB Chemedica has dedicated significant research resources over many years to better understand the neuroprotective effects of GM1 on neurons and astrocytes to evaluate its potential in the treatment of neurological disorders.
InnoMedica started its venture in 2013. The independent pharmaceutical company develops innovative medicines in the field of liposomal drug delivery systems using a patent-protected technology platform. Liposomal GM1 is currently being developed as Talineuren® for use in neurological diseases such as Parkinson’s disease, Huntington’s disease or amyotrophic lateral sclerosis. Thanks to its specific composition, Talineuren® is able to cross the blood-brain barrier and to deliver drugs directly into the brain. This has been confirmed in preclinicial studies performed by InnoMedica in Parkinson’s and Huntington’s disease models. Liposomal formulation can be administrated orally, which is expected to simplify the mode of administration of GM1 as opposed to intravenously or intramuscularly injections and to reduce side effects.
TRB Chemedica’s GM1 is produced in Vouvry, Switzerland, under GMP conditions via a proprietary production process entirely developed and scaled up on the Vouvry site. A ganglioside powder is initially obtained after different steps of cleaning, extraction and purification. It constitutes the principal raw material of the GM1 active ingredient. This raw material undergoes various industrial and biochemical treatments, including concentration and dialyses. After this processing, it then goes through an ion exchange resin based column in order to obtain a high purity GM1.
The collaboration between TRB Chemedica and InnoMedica is considered strategically important for successful clinical translation and large-scale manufacturing of liposomal GM1. InnoMedica already uses TRB Chemedica’s GM1 for the production of Talineuren® and TRB Chemedica agreed to adapt its production of GM1 based on Talineuren® clinical development steps.
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