Cyxone Announce Dosing of First Volunteer in T20K's First-in-human Trial
STOCKHOLM, July 12, 2019 /PRNewswire/ -- Cyxone (publ.) a Swedish biotech in autoimmune diseases, today announced that the first healthy male volunteer has received the initial dose in its first-in-human, clinical phase I, trial with drug candidate T20K, in development for the treatment of multiple sclerosis (MS). The clinical phase I study is estimated to be concluded during the second half of 2019.
The recruitment and screening of healthy male volunteers for Cyxone's first-in-human trial with T20K was initiated in June of this year, following the approval from the relevant authorities in the Netherlands where the study site is located. The study aims to evaluate the safety and tolerability of T20K in humans by assessing the level of T20K in the blood after administering one or two dose-levels of the substance. The first cohort of healthy male volunteers have today received their first dose of T20K through infusion, which will be followed by potentially one additional cohort receiving two doses if needed. Each cohort comprise of eight healthy male volunteers.
Kjell G. Stenberg, CEO of Cyxone, commented, "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."
Cyxone's first-in-human study with T20K is estimated to be concluded during the second half of 2019. The company will make a further announcement once the final healthy male volunteer in the second cohort has received his last dose.
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.
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, email@example.com. www.cyxone.com.
Cyxone AB (publ)
Kjell G. Stenberg, CEO
Tel: +46 (0) 723-816-168
211 22 Malmö, Sweden
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