Final preclinical studies in 2021 pave the way for the first study in humans in 2022
At CombiGene, we have just put a very intense period behind us as we established an effective and future-proof production platform for our drug candidate CG01, which is developed for focal, drug-resistant epilepsy.
During the autumn we will now test our new production platform to quality assure the entire process and produce material for the final preclinical studies. This work is expected to be completed sometime around the end of 2020 or beginning 2021, which means that we will be able to start the final preclinical studies early in 2021.
Next year will thus be a year in which we focus on completing the preclinical program with the important biodistribution and safety studies.
When the preclinical program is completed, we will apply for permission to start the first study in humans, so-called clinical studies. If everything goes according to plan – and at CombiGene we have put an honor in keeping our plans – we will be able to begin the clinical program sometime in 2022.
Since so much has happened in the CG01 project recently and since the path to the first human study is now clear, we want to make this special edition of Genevägen where we present this very exciting project in a cohesive way.
CombiGene’s vision is to provide patients affected by severe life-altering diseases with the prospect of a better life through novel gene therapies. CombiGene’s business concept is to develop effective gene therapies for severe life-altering diseases where adequate treatment is currently lacking. Development assets are sourced from an external research network and developed to achieve clinical proof of concept. Drug candidates for common diseases will be co-developed and commercialized through strategic partnerships, while the company may manage this process on its own for drugs targeting niched patient populations. The company is public and listed on the Swedish marketplace Nasdaq First North Growth Market and the company’s Certified Advisor is FNCA Sweden AB, +46 (0)852 80 03 99 email@example.com.