I am currently putting the finishing touches to the list of meetings we have booked with companies at Bio Europe in Berlin, which is being held from Monday to Wednesday this week. Bio Europe is a major event during which small companies with new technologies and substances under development meet drug companies that are looking for new projects to develop into marketable drugs. We’re looking forward to exciting meetings with companies from all over the world. Bio Europe also provides extensive opportunities for spontaneous meetings during which you can identify businesses that you we’re unaware were interested in companies such as Cyxone.
It’s then on to Munich by train for project meetings with Sourcia and our scientific experts from Vienna and Freiburg. Sourcia, researchers, and my colleague Leonard Saffer at Cyxone are working hard to conduct the studies that I have described in presentations that I have delivered in the past year, as well as in press releases and newsletters. We’re staying focused on the plans that we framed to obtain an approval for Phase 1 studies and deliver results in due course.
I understand that it can be difficult to entirely clarify the points that I highlighted in, for example, my presentations last month. It is also hard for me to provide an entirely clear picture of our multiple goals and partial goals in a line of text. I shall attempt to clarify below what these points mean in more practical terms.
T20K towards clinical studies
To obtain approval to use T20K in human trials, Cyxone has to show that the substance is highly unlikely to pose a risk to people who will be exposed to T20K. We do this with a raft of studies in animals. This includes preparatory attempts that, for example, show T20K does not stick in the tubes that are used to administer T20K, and tests to see whether the substance can be given slowly, (so-called infusion), which can be hard in small animals such as mice.
The next stage in the process is to demonstrate the take-up of T20K, how it spreads itself between organs and how it is secreted, so-called pharmacokinetics, after one dose and after repeated doses.
T20K toxicity studies
The work then continues with investigating how animals (mice and dogs) are affected by gradually increased doses of T20K. This is done to establish appropriate doses during so-called increased toxicity studies in both these types of animals. These studies are conducted over longer periods of time, and are carefully followed up to reassure regulatory authorities that T20K does not presents a risk to humans. Cyxone conducted the preparatory toxicity studies of T20K in mice in 2016, but the latest round of tests involves more animals to provide more reliable data, “full documentation”, and follow-up, which makes this attempt considerably more comprehensive.
In addition to this, several standardised short-term tests are conducted to measure, amongst other things, mutagenicity.
Cyxone recently reported the results of a series of tests with T20K that were conducted to determine whether the substance could potentially affect/attach itself to other biologically important molecules, and thereby discover whether T20K could generate toxicity effects accordingly. We’re delighted that, despite many tests, we have not found a receptor to which T20K strongly attaches itself, suggesting a reduced risk for side effects.
Cyxone has placed two substance orders with suppliers since the beginning of 2017, one of which, for a so-called non-GMP, is scheduled to be delivered at the end of this year. The other, for a GMP, is set for delivery during the first quarter of 2018. Once the T20K substance has been produced, “the product” – T20K in its preparatory form that can be given to humans – will be manufactured.
Plans for T20K and beyond
Reports and clinical protocols need to be compiled and drafted on all the completed studies and substance production prior to contact and discussions with the relevant authorities.
Following the Phase 1 study, we can look at how a subsequent Phase 2 study could be conducted. However, we do not yet have financing in place for a Phase 2, as indicated in the 2016 prospectus.
Developing new drug candidates is a long and sometimes a laborious process, but necessary to go forward with, and ultimately launch, a new, improved drug.
Turning to Rabeximod, all the development work that I have outlined above is complete and we can, once financed the project, focus on conducting a longer toxicity study in animals and a 24-week trial, Phase 2b, in patients with rheumatoid arthritis. We will begin this work once financing is in place.
I hope that this run-through explains our development programme for T20K and plans for Rabeximod. As shown, results emerge on a continual basis but we report on results only when we have clear, complete studies and results that we can trust.
I wish you all happy Halloween!
Malmö 3 November 2017
Kjell G Stenberg