STOCKHOLM, Nov. 28, 2018 /PRNewswire/ -- Cyxone (publ) announced today that the preclinical program for drug candidate T20K in multiple sclerosis (MS) has been concluded following positive results in the toxicology studies. The drug candidate T20K has now shown to be safe for people to ingest and the next step is to test the effect of T20K in clinical trials.
The toxicology studies in the preclinical program were primarily intended to investigate the safety of taking the T20K substance, but also the dose to be administered to humans in clinical trials in a so-called dose escalation study. The studies were performed with the three doses of 0.01, 0.1 or 0.6 mg T20K / kg in two species, rat and dog. The results show that at administration of 0.1 mg / kg no toxic effects on the animals could be observed. The dose-limiting effect was that the vessel at the injection site became harder and a local inflammation occurred. There were no signs of systemic toxicity, organ-specific toxicity or effects on blood chemistry even at 0.6 mg / kg.
"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," said Kjell G. Stenberg, CEO of Cyxone.
Cyxone is continuing with the planning work for T20K's clinical development program, which includes, among other things, the application to the European Medicines Agency for initiating clinical studies in humans.
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 II-program. Cyxone's Certified Adviser on the Nasdaq First North is Mangold Fondkommission AB, +46 (0)8-503 015 50.
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