First-in-human Trial: Cyxone begins Phase 1 trial with T20K for treatment of multiple sclerosis

Cyxone's application to start a first-in-human, phase I, trial with their prophylactic drug candidate T20K targeting multiple sclerosis (MS) has been approved by the accredited Ethics Committee and Central Commission on Research Involving Human Subjects (CCMO) in the Netherlands.

STOCKHOLM: Cyxone, Swedish biotech in autoimmune diseases, today announced that the company starts its first-in-human, phase I, clinical trial with drug candidate T20K for the treatment of multiple sclerosis (MS) immediately following the authorities' approval. Currently, the focus is the recruitment and screening of healthy male volunteers for the study.

Read Also: Gilead to raise stake in Belgian Biotech Galapagos in USD 5.1 billion deal: Report

Cyxone's application to start a first-in-human, phase I, trial with their prophylactic drug candidate T20K targeting multiple sclerosis (MS) has been approved by the accredited Ethics Committee and Central Commission on Research Involving Human Subjects (CCMO) in the Netherlands.

The first-in-human study with T20K is a double-blinded, singled center study in the Netherlands, where T20K will be administrated to healthy male volunteers through infusion. The study will assess the level of T20K in the blood after administering one or two doses of the substance. The purpose of the trial is to evaluate the safety and tolerability of T20K in humans and the study is conducted in collaboration with the clinical research organization (CRO) QPS Netherlands.

Kjell G. Stenberg, CEO of Cyxone, commented, "The start of our first-in-human trial for T20K is a big moment for Cyxone. Thanks to our great team and partners, we are well-advanced in preparations and could start the study as soon as we got the needed approval from the authorities. With T20K's natural origin and excellent preclinical safety profile, we look forward to evaluating our candidate's safety in humans and take another step forward towards transforming the treatment of autoimmune diseases."

Read Also: Sterling Biotech Bank Fraud: ED seize assets including business jet, ships, oil rings worth over Rs 9700 crore

The clinical phase I study is currently in the recruitment and screening stage. The first cohort of healthy male volunteers in the trial will receive the initial T20K dose in July 2019 followed by potentially one additional cohort receiving two doses if needed. The study is estimated to be concluded during the second half of 2019. The company will make further announcements once the first healthy male volunteer received the first dosing and once the last study participant received its last dose T20K.