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Kancera applies for Phase II study in COVID-19 patients

The company has submitted an application to the Swedish Medicines Agency for permission to conduct a phase II clinical study of the drug candidate KAND567 in COVID-19 patients.

The ultimate goal of clinical development is to curb hyperinflammation and thus avoid intensive care treatment and long-term rehabilitation for patients with COVID-19. The study is intended to be conducted in collaboration with Capio St. Görans Hospital and the Science for Life Laboratory.

Hyperinflammation

Kancera has previously communicated that the company has filed a patent application for KAND567 for the treatment and prevention of hyperinflammation in viral infections, a condition that is seen, amongst other times, in seriously ill patients in the ongoing COVID-19 pandemic. Hyperinflammation can occur when the immune system fails in the first stage to fight the virus. The immune system then risks becoming imbalanced and overreacting through a second wave of inflammation – hyperinflammation – which can lead to overloading of vital organs such as the lung and heart.

“Hyperinflammation can lead to serious complications in both myocardial infarction and severe viral infections such as COVID-19. Myocardial infarction is our main area, but we now want to explore the possibility of developing a treatment based on KAND567 for COVID-19 as well. As a drug development company, it is our responsibility to work with researchers and healthcare providers to make every effort to contribute to the improvement of care for patients affected by COVID-19 and we believe we have the resources to run this study as well,” says Thomas Olin, CEO of Kancera.

Kancera’s drug candidate KAND567 works by blocking the Fractalkine receptor. The receptor plays a key role when the body’s immune system initiates the inflammatory process. When the Fractalkine receptor is blocked by treatment with KAND567, certain types of immune cells are prevented from accumulating in various tissues and organs, which can attenuate a harmful inflammatory reaction. Because KAND567 acts selectively only against cytotoxic immune cells, treatment is expected to support the immune system’s ability to fight the virus that causes COVID-19 with antibodies.

Collaboration with St. Görans Hospital and SciLifeLab

A collaboration has now been initiated between Kancera, Capio St. Görans Hospital AB (Mantas Okas, MD, PhD and Mats Wistrand, MD) and Petter Brodin, MD, PhD, Science for Life Laboratory, with the aim of implementing the Phase II clinical trial of KAND567 in patients with COVID-19. In addition, Scandinavian CRO AB, Scandinavian Development Services AB and Ardena NV will contribute to the study with clinical coordination, data management and manufacturing.

“In addition, Scandinavian CRO AB, Scandinavian Development Services AB and Ardena NV will contribute to the study with clinical coordination, data management and manufacturing.”

Study design

According to the application, the study has an open design in which the medical staff and the patients are informed of whether the current treatment consists of either KAND567 in combination with the best standard treatment or only the best standard treatment. During the study, strict objective analyses of treatment effect are performed, amongst other things in the form of oxygen saturation and respiratory capacity.

In addition, a detailed mapping of immunological regulation at the cell and gene regulatory level will be carried out.

The study, which is ready to start at short notice after approval, is planned to include 40 patients, half of whom are treated with KAND567 (the other half consists of controls). The treatment with KAND567 is oral in the form of capsules twice a day for seven days.

A follow-up health examination and sampling take place after the end of treatment and after 90 days.

Photo of Thomas Olin: Kancera