Toleranzia completes Eurostars project according to plan and postpones start of clinical study
30 September - 2016
Toleranzia AB (“Toleranzia”) hereby announces that work within the EU-funded Eurostars project has been completed. The results are being compiled for final reporting to the EU in October 2016. Briefly, knowledge gained from the project indicates that further work on the manufacturing process of the company’s drug candidate will be needed to optimize the yield and quality of the product. Because of this need, Toleranzia has decided to extend the preclinical program, meaning that the clinical phase I/IIa trial is expected to start in 2018, instead of 2017.
Within the frame of the Eurostars project, Biotechpharma UAB has performed work to scale up the manufacturing process of Toleranzia’s drug candidate from laboratory scale to industrial scale. The outcome indicates that several steps in the process need optimization. Toleranzia is now evaluating the results together with Leads to Development SARL (L2D), the company’s partner in drug development, in order to plan further preclinical activities and estimate additional costs; a task that is expected to be completed during November.
“This is the first time the manufacture of a product from Toleranzia’s platform technology has been evaluated at an industrial scale. The work carried out so far has generated valuable information, establishing a basis for the optimization of the current production.”, says Jonathan Kearsey, CEO of L2D.
By expanding the preclinical program, Toleranzia intends to ensure that the more costly subsequent clinical program attains the best possible condition to be carried out both efficiently and successfully. This means that the clinical phase I/IIa study is expected to start in 2018, instead of 2017.
”The Eurostars project has been very instructive and we are pleased with the collaboration carried out with project partners and with L2D, whose expertise in manufacturing biological drugs is central to the work ahead. We see it as positive that the program can be optimized, despite the postponement of studies.”, says Charlotte Fribert, CEO of Toleranzia.
For further information, please contact:
Charlotte Fribert – CEO
Phone: +46 763 19 98 98
About Toleranzia AB
Toleranzia AB (556877-2866) has developed a platform technology for treatment of autoimmune diseases. The company´s main project is directed towards an autoimmune neuromuscular disease, myasthenia gravis, with a significant need for an effective treatment and an extensive market potential, for which Toleranzia has been granted Orphan Drug Designation in both EU and US. The platform technology enables development of therapies that target the root cause of the disease – not just the symptoms, which is the mainstay of current treatment. In addition to myasthenia gravis, the platform technology has been evaluated in three further disease indications – rheumatoid arthritis, multiple sclerosis and type 1 diabetes, where positive treatment effects have been obtained in disease-relevant animal models. Toleranzia was founded by researchers at the University of Gothenburg. The company has operations at the Biotech center in Gothenburg. Further reading at: www.toleranzia.com.
About Leads To Development SARL (L2D)
L2D specializes in the preclinical development of therapeutic products. They offer consultancy as well as regulatory and operational management services in order to help their clients bridge the gap between lead identification and clinical development. Their clients benefit from L2D’s development expertise without having to build additional internal headcount, whilst L2D ensure that their products are advanced rapidly and cost effectively to clinical proof of concept trials. They offer a personal service carefully tailored to their customers’ needs that maintains the transparency, flexibility and availability associated with an internal team. Their expertise covers a wide range of therapeutic product types including small molecules, peptides, proteins, and vaccines, as well as cell and gene therapies. This expertise has been built across a spectrum of disease indications including oncology, neurology, metabolism, infection and immunology, together with auto-immune and inflammatory diseases. Further reading at: www.leadstodevelopment.com.