During the recent months, we have been able to communicate milestones that we, together with our collaboration partners, have worked hard to fulfill. Both T20K and Rabeximod have during summer taken strong steps forward in their respective development plans in accordance with objectives set during our preparatory work in 2018. In this newsletter, I would therefore like to take the opportunity to give some additional descriptions to our work and to inform you about the upcoming series 3 warrant.
We recently sent out an invitation to investor meetings in Gothenburg on Sep 4, Malmö on Sep 10 and Stockholm on Sep 16. During these, I plan to make a brief presentation of the company and then open up for questions. The pharma industry is complex, and where you always have to choose a path to reach your preselected destination. I hope that when we meet, I will be able to clarify Cyxone’s path and answer your other thoughts directly. We have chosen to hold the meetings in the evening this time, starting at 18.00, as many do not have the opportunity to attend during the day. Registration is done according to the invitation on the website.
As always, keep getting in touch with me. I respond to the extent that I am permitted, given the market rules, either as a direct response or to a wider audience, such as in this newsletter or at an event. Other information relevant to the company can also be found at www.cyxone.com.
I hope to see you at one of the investor meetings in the coming weeks!
Malmö September 2, 2019
Kjell G. Stenberg
T20K and MS
Completed Phase I infusion study after positive results
During the past month, I have understood from several directions that a clearer description of both study design, workflow and results may facilitate understanding of T20K’s further development plan. The study results announced at the beginning of August was released after the so-called First in Human, Phase I, study with infused (i.e., slowly injected) T20K was concluded after successfully achieving the goal of the study. We have now confirmed that a certain amount of T20K does not cause acute side effects in humans. We can thus state to the authorities that we have established a “safe” level of T20K after a one-hour infusion with the substance.
We did not know if we could measure the amount of free T20K substance in the blood of the healthy volunteers with the lowest dose level, i.e. what we call cohort 1, before the study start. The reason for this uncertainty was that we thought the lowest dose of T20K could have been completely absorbed by the body before the measurement could take place. It actually sounds like this would be something good, but in a study such as this, it means instead that the measurement would not show the correlation between the amount of T20K in the body and how healthy volunteers react. Therefore, we designed a study with eight treatment cycles, each with increasing dose levels. Based on animal data, however, we thought we would only need one or two cohorts to achieve the study’s purpose. But since a clinical study is a big undertaking, our CRO in the Netherlands started recruiting for all cohorts just to be on the safe side. Following the cohort 1’s treatment completion and the data was analyzed, a meeting was held with the Scientific Review Committee (SRC), part of the Dutch Medicines Agency. Given the clearly measurable amount of T20K in the blood and that no side effects related to the substance other than a single transient mild headache were reported, it was determined in consultation with the authority that the evidence from cohort 1 is sufficient for the study’s objective to be considered completed. Therefore, no further higher doses were needed, and the program was concluded.
For Cyxone, this was a big win, not only because T20K’s safety was clearly shown, but also because it went quicker than we previously dared to hope. With the study now behind us, we have shifted our focus to preparing an oral preparation of T20K, which is the form of administration that is mainly requested by both patients and doctors as this is more easily manageable, among other things. In tablet form, T20K will then undergo a similar Phase I study, but lower doses can then be used to confirm its safety and tolerability in humans.
Rabeximod and RA
Continued preparation for the upcoming Phase IIb study
For Rabeximod, our focus has since spring 2019 laid firmly on completing the documentation needed to start a multicenter Phase IIb study with clinical sites in several European countries. The study will be held in both West and East Europe, the reason for this is partly to be able to quicker include patients in the Rabeximod study and to find patients who have not previously been treated with biological drugs. Patient recruitment is, as you may know, one of the major challenges for all pharma companies, big and small. This is also why we have chosen to collaborate with two very knowledgeable and experienced clinical research organizations (CRO): Sourcia, that are experts in Western Europe, while EGeen has its focus on Eastern Europe.
Several applications to start the study have been submitted and the response we have received so far has been positive. The further we get in the drug development process, the more documentation and longer planning is required, as is appropriate. We will announce news about approvals in the different countries as soon as possible.
Series 3 warrant
To remind us, the company carried out a rights issue during the autumn of 2018 with the aim of providing the company with more capital to be able to secure the continued development of our portfolio. The rights issue was of so-called units, in which one unit consisted of a share and a warrant. We are now in the period when you can use your warrant, also called TO3. We hope those with the possibility to do so will exercise these warrants to continue supporting the company’s development plans.
More information will be available on our website during the subscription period.