Cyxone submitted an application to the Netherlands research ethics committee to start the first clinical trial in humans testing T20K, its investigational preventive treatment for multiple sclerosis (MS).
Approval by the Netherlands regulating authority — the Ethics Committee and Central Commission on Research Involving Human Subjects (CCMO) — will advance Cyxone’s plans to start a Phase 1 clinical study of healthy volunteers in the second quarter of this year.
T20K is a compound derived from a natural plant protein, and is being developed by Cyxone as a new MS treatment with prophylactic (preventive) properties.
Scientists at the Medical University of Vienna, Austria, and the University Medical Center in Freiburg, Germany, showed that T20K inhibited the production of pro-inflammatory cytokines (immune messengers that mediate inflammation) such as IL-2, and effectively reduced clinical symptoms in animal models of MS, with no significant toxicity.
According to Cyxone, T20K could be used to ease or prevent MS episodes, and even delay disease progression.
Based on these preclinical results, Cyxone believes that T20K stays in the bloodstream in small amounts, which suggests it will be effective at low doses and with reduced toxicity risks. This also indicates that T20K may be prescribed to patients immediately or shortly after diagnosis, in order to slow disease progression or reduce the severity of flare-ups.
An early disease intervention like this is currently not possible with available medications, which are designed to treat active disease flares, Cyxone emphasized.
The planned first-in-human study will be a double-blind, single-center, Phase 1 clinical trial, to evaluate the safety and tolerability of T20K in healthy male volunteers. T20K will be administered intravenously.
The trial will be conducted in collaboration with the contract research organization QPS.
“We are glad to be able to share this milestone as it means that our drug candidate is on the cusp of making history by hopefully, very soon, [being] tested in humans. We have a good partner by our side in QPS, which is a global leader in clinical development, with the purpose of giving our study the best prerequisites for success,” Kjell G. Stenberg, CEO of Cyxone, said in a press release.
“We are fully prepared to start recruiting study participants as soon as the application has been approved by the relevant authorities, and look forward to continuing this collaboration,” said Benjamin Chien, CEO of QPS.