Cyxone said that T20K, its investigational drug for the treatment of multiple sclerosis (MS), has succeeded in a preclinical program by yielding positive results in the toxicology studies.
According to Cyxone, T20K during the preclinical program has been shown to be safe for people to ingest. The Swedish clinical biotech company, which has concluded the preclinical program, is now planning to evaluate T20K in clinical trials.
It said that the toxicology studies were mainly planned to evaluate the safety of taking the T20K substance. The studies were also used to determine the dose to be given to humans in clinical trials during a dose escalation study.
Cyxone CEO Kjell Stenberg said: “This is a significant milestone for the drug candidate. We are very pleased to see a good safety profile on this natural plant protein that meets our expectations and, with confidence, now look forward to the forthcoming steps in the T20K development program.”
The Swedish firm said that the preclinical studies used T20K in three doses of 0.01, 0.1 or 0.6mg/kg in two species, rat and dog. Out of them, the 0.1mg/kg dose did not show any observed toxic effects in the animals.
As far as dose-limiting effect was concerned, the vessel at the injection site became harder while leading to local inflammation. Further, there were no indications of systemic toxicity, organ-specific toxicity or effects on blood chemistry even at a dose of 0.6mg/kg, said the clinical biotech company.
Currently, Cyxone is planning a clinical development program of T20K, which includes application to the European Medicines Agency for launching human clinical trials.
Last month, the company selected a clinical site in Western Europe to carry out the first human trial for T20K.
Cyxone has a portfolio of immunomodulating drugs that are being developed for the treatment of autoimmune diseases.
The company’s drug portfolio is based on oral molecules and cyclotide-based drugs that hamper key processes in the body’s cells that are associated typically with several immune-related disorders.
Apart from T20K, the Swedish company is developing a drug, dubbed Rabeximod, for the treatment of rheumatoid arthritis, which is currently evaluated in a clinical phase 2 program.