As the days get shorter and the darkness falls earlier and earlier for each day, I am very happy about the many good news that has come to characterize Cyxone lately, which is also reflected in this newsletter. Most central is among other things the successful TO3 that expired in September. We are pleased with the confidence in us that was shown through the large number that exercised their warrants; a full 66%. This has brought in SEK 62.4 million to the company. This money will come in good use to drive Rabeximod through both toxicity study and phase 2b trials and to take T20K further in the oral development program.
So, even though we are heading toward darker times outdoors, Cyxone’s work is characterized by a bright vision of the future and the opportunities that lies ahead. This does not come without hard work, and I am therefore much grateful for our competent and dedicated team and our partners, who together work with the company’s two promising candidates. Our vision of being able to offer new effective and safe drugs that can improve the quality of life for those affected by autoimmune diseases is shining brightly in front of us.
Furthermore, in the midst of all this, I would also like to highlight and thank all shareholders and other stakeholders who took the time to meet us in Stockholm, Gothenburg and Malmö during our investor events; many rewarding meetings and conversations. I also appreciate the emails you send and try to respond as best I can and am allowed – and I urge you to keep following press releases and newsletters for more information about what comes ahead.
Having said that, I wish you a pleasant autumn.
Malmö, November 6, 2019
Kjell G. Stenberg
CEO of Cyxone
With a good addition of capital and strengthened by the great confidence our investors have shown in us, we are now pushing forward in the continued work with Rabeximod. We have two main points on the agenda ahead; a six-month toxicology study in two animal species required by the authorities, and encapsulation of the GMP quality of Rabeximod substance that was included in the acquisition of the project from OxyPharma.
The toxicology study will be conducted for six months, twice the time compared to the 12-week phase 2b study conducted by OxyPharma. However, the test subjects will not receive more substance than previously, since no toxic effects of Rabeximod were noted. I see no reason to believe that a longer study would cause “new” toxic effects, but the studies still need to be done to get authority approval to treat patients for 24 weeks, which is the planned time frame for the upcoming phase 2b study. We are currently evaluating several different companies that could conduct the study with utmost care, to ensure that they offer good conditions for the test. These types of issues are a key concern of mine, and already in the 1980s, I researched to develop cell models to investigate the toxic effects of substances in order to minimize the use of animal models to the extent possible. With a long commitment to these issues, I will continue to have a proactive relation with the companies we employ for these types of assignments.
In parallel with the toxicology study, preparations of the substance itself to be used in our phase 2b study in patients with rheumatoid arthritis are also being conducted. We have already manufactured Rabeximod substance in GMP quality, but this is now in granulated form, i.e. as a powder, while it is a capsule that will be used in the study. Therefore, we need a new large batch of pre-encapsulated Rabeximod – almost twice as many as will be given to patients (including placebo capsules), as it is necessary to conduct continuous controls before, during and after the study, to ensure that nothing happened to the product during handling and storage. The capsules need to undergo a wide range of pre-studies, production system checks and analyses through each step to ensure that all the quality and patient safety requirements for the product are upheld. This is an exciting step forward and here the capital injection comes to good use.
Recently, the phase 1 study conducted by Cyxone together with QPS in the Netherlands was conducted. We are very pleased with the positive results that came from the study where T20K could be measured in blood plasma at the very lowest dose, 0.005 mg/kg, while none of the healthy volunteers showed any symptoms of side effects from the treatment. Just the results we were hoping for.
Backed by these promising results, we are now focusing on developing a good oral preparation for T20K, as we know that patients prefer to be able to take a tablet or capsule instead of an injection. Furthermore, we will already now start work on a study of a phase 1 trial with T20K in an oral preparation that as easily as possible paves the way for a phase 2 study where T20K’s unique properties can be clearly demonstrated. With our dedicated and competent team, I have good hopes for our future progress.
At Cyxone, we always have our sights set on an international horizon and therefore it makes me so happy when we become noticed in the larger contexts – as we have felt lately. I would also like to emphasise that we have received good feedback from pharma companies and increased interest from investors in Europe and the US, but this is something I cannot go into more detail about at the moment.