Can-Fite announces pre-IND submission to US FDA for Piclidenoson in treatment of Covid-19 infected patients with moderate-to-severe symptoms

Can-Fite BioPharma, a biotechnology company advancing a pipeline of proprietary small molecule drugs that address inflammatory, cancer and liver diseases, today announced it has filed a pre-Investigational New Drug (IND) meeting request with the U.S. Food and Drug Administration (FDA) for its drug candidate Piclidenoson in the treatment of COVID-19 patients with moderate-to-severe symptoms.

Through the pre-IND, Can-Fite anticipates receiving the FDA’s advice and guidance on its planned clinical study protocol. Following the FDA’s advice, Can-Fite plans to submit an IND application for Piclidenoson to be evaluated as a potential addition to the current standard of care treatment for COVID-19.

Piclidenoson, an A3 adenosine receptor (A3AR) agonist, has a well-established safety record in the U.S. and globally, and has been dosed in over 1,000 patients in clinical studies for the treatment of rheumatoid arthritis and psoriasis. The use of A3AR agonists as potent anti-inflammatory agents in addition to standard of care in acute infectious diseases where host defense responses are overwhelming, leading to cytokine storm and death, is supported by several peer reviewed studies, as well as by Can-Fite’s own work in the field of adenosine biology. A3AR agonists are effective in models of inflammation and sepsis.

“We look forward to our discussions with the FDA regarding moving forward into a clinical study of Piclidenoson for COVID-19. The literature, our experience in adenosine biology, and the favorable human safety experience of the drug support the exploration of Piclidenoson as an add-on therapy to standard of care for COVID-19 patients who are hospitalized with moderate to severe symptoms,” stated Can-Fite CEO Dr. Pnina Fishman.

Piclidenoson is a novel, first-in-class, A3 adenosine receptor agonist (A3AR) small molecule, orally bioavailable drug with a favorable therapeutic index demonstrated in Phase II clinical studies. Piclidenoson is currently under development for the treatment of autoimmune inflammatory diseases, and for the treatment of COVID-19.

It is being evaluated in multinational Phase III studies as a first line treatment to replace methotrexate in the treatment of rheumatoid arthritis, and as a treatment for moderate-to-severe psoriasis. Piclidenoson has been approved for a pilot clinical trial in Israel to treat hospitalized COVID-19 infected patients with moderate-to-severe symptoms.

Source: Company Press Release