Kancera develops the dosing strategy for KAND567 which means an added delay of the phase 1b study
2019-08-26
Kancera today announces that a further developed dosing strategy is intended to be tested for the treatment with KAND567. The reason is that the modified intravenous dosing studied in the phase Ib study in August 2019 resulted in a clearly improved but not sufficiently high tolerability for prolonged continuous infusion. The new dosing strategy is based on a combination of a shorter intravenous dosing and a subsequent oral dosing of KAND567 in line with clinical practice for the cardiac care of patients with infarction. The results obtained from the phase 1 studies support that such a dosing strategy gives the desired effect and tolerability. The described adjustment of the ongoing Phase Ib study requires a formal approval from the Swedish Medical Products Agency where the processing time is normally thirty days. Thus, Kancera estimates that the study can be completed in November with reporting of the results in December this year. The company’s previous assessment was that the study would be reported in November 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.
In June, Kancera announced positive interim results from the ongoing Phase Ib study of KAND567, which showed that KAND567 has a good safety profile with shorter infusion times and that the calculated effective plasma concentration can be achieved according to plan. However, with prolonged infusion, local irritation was observed at the infusion site. To achieve the required tolerability for prolonged infusion, the concentration of KAND567 was decreased while the infusion rate was increased. This change gave a clearly improved but not sufficiently high tolerability. Based on these results and clinical practice for cardiac care of patients with infarction, Kancera now intends to prepare for a combination of 12 hours of intravenous infusion in combination with up to three days of oral therapy in the planned phase IIa study in myocardial infarction patients.
The purpose of the ongoing Phase Ib study in healthy subjects is to study the safety and tolerability of an intravenous infusion of KAND567, as well as to generate information on optimal infusion rate to quickly reach a specific desired plasma concentration.
In line with what is prescribed in the study protocol, a supplement to the written information concerning the phase Ib study is prepared for submission to the Swedish Medical Products Agency. The purpose of this supplement is to test the intravenous part of the new dosing strategy, which means shorter intravenous infusion than the one described in the current study protocol.
The results from studies of intravenous infusion of KAND567 in completed parts of the ongoing phase Ib study and the completed phase Ia study support that intravenous dosing over 12 hours and oral dosing over three days is sufficient to achieve the effective plasma concentration and is well tolerated. Based on this and the project’s underlying preclinical documentation showing safety and cardiovascular protective effect, Kancera’s overall assessment is that there is strong support for continued implementation of the phase Ib study of KAND567.
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 during the first half of 2020. 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
Sweden.
Welcome to visit our home-page: www.kancera.com
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