I hope that you have all had a happy and pleasant Easter, even if the weather was rather patchy at times.
In March and April, Cyxone, together with researchers in Vienna, Freiburg and our strategic partner Sourcia, processed the results of the T20K study with a view to developing a coherent plan to begin human trials of T20K as soon as possible. Painstaking preparation is the best way to save time and money to successfully negotiate the development programme and obtain a licence for clinical studies.
Following work by the respective parties, development groups from Austria, Germany, the Netherlands and Sweden met on April 13th to agree a strategic direction for T20K’s development.
We will conduct the preparatory Investigational New Drug (IND) studies with injected T20K because we need to establish the link between administered doses, amounts of T20K, and their effects in animals to progress to human trials. Once this connection has been made, we can use this information to switch over to an oral preparation of T20K for forthcoming Phase II studies.
We are now in the process of reviewing offers from various companies specialised in measuring EAE effects, toxicity, pharmacology, pharmacokinetics and distribution etc., that we need to prepare the necessary material to apply to conduct in-human studies.
I will announce the identity of our co-operation partners at a later date, along with a time-plan and regular updates of the results of our work. Below, I would like to provide a brief overview of our development plan for 2017.
Development plan for T20K
We’re basing our plan on findings that developers and Cyxone have collected, which show a clear safety margin between effective and toxic doses of T20K, and that pre-treatment with the substance appears to protect animals from late development EAE.
The selectivity that T20K indicates, and the opportunity of administering doses over longer periods, are supporting factors for the development of an MS treatment, and we will use these properties to optimise future use of T20K to combat the disease.
Attempt to mirror intended clinical treatment
We plan to simulate the intended clinical use of T20K by treating animals with EAE when their condition worsens in the same way that people with MS can take medicine when they exhibit symptoms. This means that we can administer treatment at an extremely early stage in the development of the disease, and can see whether by doing this we can prevent the further development of the disease. I took part in a meeting with the Norwegian Inflammation Network in Oslo recently, where I received conformation from Norwegian MS experts that possibly the most important factor for successful MS treatment was to stop its development at an early stage with effective drug treatment.
We will also analyse how long intervals between T20K doses need to be to maintain positive results in the EAE model. This would reduce stress on patients affected by MS.
Establish whether we can reduce side effects with slow doses over time
It may be possible to reduce the risk of side effects with sustained anti-inflammatory loads by giving repeated, lower doses of T20K over time. This could result in a product with milder side effects more likely to be tolerated over time by MS patients.
Other development activities
In addition to the studies outlined above, we will manufacture T20K for animal and clinical trials. We will also develop bio-analysis methods for T20K and expand our pharmacokinetic studies. Finally, we will conduct pharmacological studies in conjunction with toxicity studies.
First in-man studies
When we have determined the appropriate doses, and have identified appropriate plasma- and equivalent tissue levels, we will be able to design and conduct reciprocal studies in humans. This study will indicate which levels of T20K can be tolerated in humans, and pave the way for the development of an oral T20K preparation for upcoming clinical Phase II studies.
I have now met representatives of most of the companies that I believe will be interested in partnering on T20K. Many people have shown keen interest in T20K and its properties to treat MS. I have followed up discussions by supplying study findings, and describing how T20K could make an excellent contribution to respective companies’ project portfolios. As previously indicated, such discussions take time. I am highly focused on securing partnerships that provide knowledge, resources and a timely planning structure to launch T20K as a new MS product with strong potential.
Malmö in April 2017
Kjell G Stenberg
CEO Cyxone AB