Statement from the CEO
The first quarter of the year was characterized by intensive preparations for the clinical trial with our main candidate KAND567 in acute myocardial infarction, which we plan to initiate in 2019. In January, we received the results from a preclinical toxicological study showing that the Fractalkine inhibitor KAND567 also has a favorable safety profile when given intravenously, which is very important in acute treatment. At the same time, we were able to announce that significant progress was made in the development of a large-scale production method for the intravenous dosage form, which made it possible to begin the production of study drugs. There have been good results for safety tests and oral dosing of KAND567 in humans before, but in acute myocardial infarction, KAND567 will need to be given intravenously to rapidly reach effective levels of KAND567 in the blood. During the summer we therefore conduct a complementary phase Ib study in healthy subjects to determine the appropriate intravenous dosage rate for the future patient study. After the end of the reporting period, we were pleased to announce that the Medical Products Agency and the Ethics Committee approved our application to carry out the Phase Ib study, expected to start in June.
The intravenous dosage form of KAND567 is intended to be used in the Phase IIa study in patients treated with acute myocardial infarction. The application to the authorities for a trial permit for that study can only be made later this year when final results are available from the phase Ib study. The results from the patient study are expected to be reported approximately 12 months after the start of the study, and will constitute an important basis for negotiations on the out-licensing of KAND567 to pharmaceutical companies.
We recently nominated another drug candidate in the Fractalkine project, KAND145. With two independent drug candidates covered by separate patent applications, the possibility of developing two independent products in the future increases. Potentially, this may result in a drug for the treatment of inpatient heart attack and another drug targeted at the treatment of inflammatory diseases.
Fractalkine blockers also have the potential to develop into effective drugs against various forms of cancer. During the first quarter of 2019, a study was completed to clarify whether the Fractalkine system is activated and possibly causative in patients suffering from lymphoma. The results, which include blood cell analyzes from 66 patients, show that there is a statistically significant activation of the Fractalkine system in the lymphoid patients compared to a control group consisting of healthy subjects of the same age distribution. The study was carried out by researchers at Karolinska Institutet in collaboration with Kancera. Based on the research results, Kancera has decided to deepen its laboratory studies with the aim of determining whether drugs that control the Fractalkine system have the potential to develop into an improved treatment of lymphoma. These follow-up studies are expected to be completed during the third quarter of this year.
However, our focus remains on the development of KAND567 to reduce the harmful inflammatory process that arises in connection with the treatment of acute myocardial infarction. We are now looking forward to initiating the first clinical study with the intravenous dosage form to be used in the continued development program.
Solna, 24 May 2019
Thomas Olin, CEO