A first group of healthy volunteers in a Phase 1 trial assessing the safety and tolerability of T20K, Cyxone‘s plant protein-derived candidate for the treatment of multiple sclerosis (MS), has been dosed in a study taking place in The Netherlands, the company announced.
T20K is an investigational prophylactic (preventive) therapy, possibly intended for all MS forms. The eight male volunteers that make up a group are being given one or two infused doses of the potential treatment and their blood analyzed.
Previous preclinical studies showed that T20K could inhibit the production of pro-inflammatory cytokines (immune messengers that mediate inflammation), such as interleukin-2 (IL-2), and effectively ease disease symptoms in animal models of MS, Cyxone said in a press release.
The therapy, given orally to the animals, was also found to have low toxicity, and favorable absorption and distribution in the body. Essentially, this means the compound may be administered at low doses with long periods between administrations (once every two weeks, or perhaps once a month) and should still be effective.
Recruitment and screening of study participants started in June, after Cyxone received the approval from the Dutch Ethics Committee and Central Commission on Research Involving Human Subjects (CCMO) to launch the trial.
The trial is being carried out by Cyxone in collaboration with the clinical research organization QPS Netherlands.
Its main goal to evaluate the safety and tolerability of T20K in humans after one or two doses, by measuring the levels of T20K in their blood.
According to Cyxone, the first group of eight volunteers may be followed by a second eight-person group, if necessary for good data.
“This is an important moment in our company’s development taking us another step closer to the end goal. I am very pleased with our partner QPS Netherlands’ swift recruitment and screening of participants to this study and, albeit cautiously, looking forward to the conclusion of the study,” Kjell G. Stenberg, chief executive officer of Cyxone, said in the release.
Cyxone expects the trial to finish in the second half of 2019.
The company does not detail on its website what type of plant proteins are in the compound, but is aiming for a treatment that “could be used to mitigate or even prevent MS episodes and potentially even delay the disease progression,” and with fewer side effects than those now seen in pharmaceutical compounds.
Why are no women in this trial ?
It is a normal study design that only Healthy men are tested in phase 1 trials
Good question, since more women have…
Kelly