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20-Jun-2019

Cyxone Initiates First-in-human Trial With T20K for the Treatment of MS

STOCKHOLM, June 20, 2019 /PRNewswire/ -- Cyxone (publ.), a 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.

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."

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.

Contact
Cyxone AB (publ)
Kjell G. Stenberg, CEO
Tel: +46 (0) 723 816 168
Email: kjell.g.stenberg@cyxone.com
Adelgatan 21
211 22 Malmö, Sweden

This contains such information that Cyxone AB is required to make public under the EU's Market Abuse Regulation. The information was provided under the auspices of the above contact person for publication on June 20, 2019 at 12.35 CET.

This press release contains forward-looking statements that constitute subjective estimates and forecasts about the future. Assessments about the future are only valid on the date they are made and are, by their nature, similar to research and development work in the biotech field, associated with risk and uncertainty. In light of this, actual outcomes may differ substantially from what is described in this press release.

About T20K
T20K is in development as a novel form of multiple sclerosis (MS) treatment with prophylactic properties. Results from preclinical studies demonstrate that the candidate could be used to mitigate or even prevent MS episodes and potentially even delay the disease progression. Early disease intervention, such as this, is currently not targeted by the treatments available. Additionally, the candidate has demonstrated a low toxicity level and could, due to its favorable absorption and distribution in the body, be administrated at low doses on a bi-weekly or even monthly basis.

About Cyxone
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 clinical phase I 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, ca@mangold.se. www.cyxone.com

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SOURCE Cyxone

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Last Updated: 20-Jun-2019