2019 20 mar 10:01 First North
Cyxone AB : Cyxone announces strategic intent to position its drug candidate T20K in MS as a prophylactic agent
Cyxone (publ), a Swedish biotech in autoimmune diseases, today announced that
preclinical findings support the positioning of its drug candidate T20K as a
prophylactic agent for the treatment of multiple sclerosis (MS). This indicates
that the substance could be used to mitigate or prevent MS episodes and
potentially even delay the disease progression. Early disease intervention, such
as this, is currently not targeted by other treatments available.
The preclinical studies performed last year revealed further understanding of
the drug candidate T20K and findings indicate that the drug could be used to
prevent or slow down MS disease progression. New knowledge on how T20K is
absorbed and distributed in the body suggest that the drug could be
administrated at low doses on a bi-weekly or even monthly basis, which could
have a substantial impact on MS patients’ quality of life in the longer term. A
prolonged drug excretion from tissue would entail that only very low amounts of
T20K would be circulating in the patient’s body at any given time, resulting in
a markedly reduced risk of systemic toxicity. A drug with such a low toxicity
level, could possibly be given to patients directly at diagnosis or shortly
thereafter with the potential of slowing the disease progression in comparison
to patients not receiving early intervention with T20K. This would mean that the
patient’s next MS episode would be significantly delayed and possibly also with
milder symptoms. This strategic direction will position T20K as a novel
treatment aimed at preventing or mitigating MS episodes rather than treating
active MS episodes, which is the current standard of care.

Kjell G. Stenberg, CEO of Cyxone, commented: “If T20K continue to demonstrate
its effect in human studies, which we have no indications otherwise, we believe
that this could transform the way we look at severe autoimmune diseases such as
MS. Both how we treat the disease but also how patients perceive a diagnosis
since their outlook would have changed. With T20K being a natural plant protein,
a cyclotide considered an ideal ‘template’ for novel drugs, we are excited to
know more about its abilities in the upcoming clinical studies.”

Cyxone is currently making the final preparations ahead of the initiation for
the first human trial, also called a phase 1 study. The application to start the
clinical trial will be submitted during the second quarter of 2019. The
continued work with T20K will importantly focus on finding a dose regimen that
puts an efficient brake on disease progression while not harming other vital
body functions, why the phase 1 trial in healthy volunteers will be vital for
the company’s continued strategic planning.

Cyxone AB (publ)
Kjell G. Stenberg, CEO
Tel: +46 (0) 723 816 168
Email: kjell.g.stenberg@cyxone.com
Adelgatan 21
221 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 March 20, 2019 at 10.00

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 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 preclinical
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