Kancera announces positive interim results and a minor delay in ongoing Phase Ib clinical study of KAND567
2019-06-24
Kancera today announces positive interim results in the ongoing Phase Ib study of KAND567, which aims to study intravenous infusion of the drug candidate to healthy subjects. The first exploratory part of the study shows a good safety profile at shorter time infusion and that the calculated effective plasma concentration can be achieved according to plan. In the following part of the study a local irritation at the infusion site was observed with prolonged infusion. To achieve the required tolerability during prolonged infusion, the ratio of infusion rate to concentration of KAND567 in the infusion solution needs to be adjusted. Such an adjustment is possible within the scope of the approved study protocol. Continued dosing requires a formal approval from the Medical Products Agency, for which the processing time is normally thirty days. Thus, Kancera estimates that the study’s objectives can be finalized in October with reporting in November this year. The time frame for completion of the study was earlier estimated to be September 2019.
Kancera develops drugs that counteract damage during acute and chronic inflammation. The Fractalkine blocker KAND567 is primarily developed to effectively reduce the inflammation in the heart and vessels after myocardial infarction. An intravenous administration is required in order to rapidly achieve effective plasma concentrations of KAND567 in the acute phase after the infarction.
The purpose of the ongoing Phase Ib study is to study safety and tolerability at various infusion rates of KAND567, and to generate information about the optimal infusion rate to quickly reach a specific target plasma concentration. KAND567 is given as an infusion at different rates on up to three days to groups of healthy subjects. Study results will form the basis of the dosing strategy in the planned clinical Phase IIa study in patients suffering from myocardial infarction.
The first exploratory part of the Phase Ib study has been successfully completed and shows that KAND567 is safe to give during shorter infusion times and that the calculated effective concentration of KAND567 can be achieved according to plan. In the following part of the study, it was confirmed that the chosen dosing strategy quickly led to the desired concentration in the blood, but that the low infusion rate of a concentrated solution of KAND567 upon prolonged infusion caused irritation at the infusion site. To avoid this, the ratio of infusion rate to concentration of KAND567 in the infusion solution will be adjusted. Previous animal studies have shown that KAND567 is safe to deliver at doses 8-fold higher than the calculated effective dose without any infusion site reaction for 14 days of continuous infusion. This suggests that good tolerability at the injection site during continuous infusion during up to three days in humans can be achieved with an infusion solution of KAND567. This infusion maintains a lower concentration but is administered at a rate that gives a higher volume than that used so far in the ongoing Phase Ib study. The adjusted infusion volume and rate intended to be used in the future are well within the limits routinely applied when treating patients suffering from myocardial infarction.
In line with what is described in the study protocol, the written information about the Phase Ib study is now submitted as a supplement in order to receive a response from the Medical Products Agency.
The chosen dose level in the Phase Ib study has a good safety margin as indicated by data from both a previous human study and animal studies. Based on this, Kancera’s overall assessment is that the documentation of KAND567 strongly supports continued implementation of the study with the aim of completing and reporting the study in November with high quality.
About Kancera AB (publ)
Kancera develops drugs that counteract damage during acute and chronic inflammation. The Fractalkine blocker KAND567 is primarily developed to effectively and selectively reduce the inflammation of the heart and vessels following a heart attack and is expected to enter the clinical phase II study in 2019. Since scientific studies have shown elevated levels of Fractalkine not only in heart attacks but also in inflammatory diseases and certain forms of cancer, there are several possible development opportunities for the Fractalkine blockers KAND567 and KAND145. Kancera also develops preclinical drug projects against cancer aimed at stopping survival signals in the cancer cell and preventing the cancer cell’s ability to be repaired. Kancera operates at Karolinska Institutet Science Park in Stockholm. The share is traded on Nasdaq First North. FNCA Sweden AB (tel. 08-528 00 399, info@fnca.se) is the company’s Certified Adviser. MD PhD Charlotte Edenius, MD PhD Anders Gabrielsen, Professor Carl-Henrik Heldin and Professor Håkan Mellstedt are all scientific advisors and board members of Kancera AB.
For further information, contact:
Thomas Olin, CEO: +46-(0)735-20 40 01
Adress:
Kancera AB (publ)
Karolinska Institutet Science Park
Banvaktsvägen 22
SE 171 48 Solna
Welcome to visit our home-page: www.kancera.com
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