Clinical evaluation in patients
The results of a Phase I study in which KAND567 was administered orally to healthy volunteers show a favorable safety profile at dose levels that are considered sufficient to achieve pharmacological effect. The few side effects that were observed, nausea and liver effects, disappeared after treatment was completed. An analysis of biomarkers during the Phase I study also shows that KAND567 has an effect on the Fractalkine receptor in precisely those types of immune cells which in the British study were assumed to cause heart damage.
In 2019, Kancera plans to carry out a complementary Phase I study to determine an appropriate dose level for the intravenous dosage form of KAND567. In parallel, a placebo-controlled and double-blind phase IIa study is being prepared for heart attack patients in Sweden and the UK for a possible start during the first half of 2020.
It is often demanding to carry out clinical studies in emergency care. Kancera therefore cooperates with clinicians who have extensive experience in drug trials in patients with acute heart disease. Primary efficacy measures will be safety and tolerability. In addition, markers for heart damage and cardiac function will be followed in the study. The results are expected to be available within 12 month of start of phase IIa.
The patent protection for Kancera’s Fractalkine blockers is based on three complementary patent families. The main patent for KAND567 was submitted in 2006 and is valid until 2030, including the extension that applies to marketed products. In 2018, Kancera applied for another two patents, partly for a second generation of blockers of the Fractalkine system and partly for an improved synthesis method for producing Kancera’s Fractalkine blockers. When the new patents are approved, they will apply until 2038.