Cyxone selects first clinical site ahead of phase 1 study with T20K in MS
Cyxone AB (publ) announced today that the company has selected the clinical site that will carry out the drug candidate T20K's first in man study. The clinical site located in Western Europe has been carefully evaluated based on a number of crucial criteria and will treat the first healthy volunteers in the T20K clinical phase 1 study developed for the treatment of multiple sclerosis (MS). This means that the company is well aligned with the planned preparations for T20K's first clinical study prior to the start of recruitment of healthy volunteers as well as completion of the remaining preclinical program.
The drug candidate T20K in MS currently undergoes the final parts of the required preclinical program prior to the start of the first clinical study in man at the clinical site located in Western Europe. The remaining part of the preclinical program consists only of toxicology studies where the substance is shown to be safe for humans to ingest. Cyxone has, according to plan, carried out toxicology studies in two animal species, first in rat and then in dog. Additionally, it is also investigated that the substance is seeking itself to the right organ, which is done by comparing the distribution of T20K in the body with intravenous and oral administration. At present, a final report is awaited with complete data analysis from the company's collaboration partner, but overall indicative results indicate a good safety profile, where studies in both animal species indicate similar results.
“With the preclinical studies soon completed, the choice of the first clinical site for studies in man is one of the major pieces in the preparatory jigsaw puzzle. We are very pleased to have found a credible partner that we know have the right prerequisite for the first in man study with T20K, both in terms of competence, but also with a network of access to the ideal type of healthy volunteers who can be included in the study,” says Kjell G. Stenberg, CEO of Cyxone.
The company is preparing to submit an application to start clinical studies, and toxicology studies with the drug candidate T20Ks is the last remaining part of the preclinical program. Cyxone will announce to the market when the final report of toxicology studies has been received by the company.
Cyxone AB is a clinical stage biotech company with a portfolio of immunomodulating drugs for the treatment of autoimmune diseases such as multiple sclerosis (MS) and rheumatoid arthritis (RA). The company’s drug portfolio is based on two technological pillars in the form of oral molecules and cyclotide-based drugs that inhibit key processes in the body’s cells that are typically associated with various immune-related disorders. Cyxone’s technologies have the potential to address an unmet need and provide new effective and safe medicines that can improve the quality of life for patients affected by autoimmune diseases. The company has two drug candidates, T20K for MS in a preclinical program and Rabeximod for RA in clinical phase 2 program. Cyxone’s Certified Adviser on the Nasdaq First North is Mangold Fondkommission AB, +46 (0)8-503 015 50.