Type: First-in-class, A3 adenosine receptor agonist (A3AR) small molecule, orally bioavailable drug
Status: Can-Fite said July 15 it amended its Phase II COVID-19 study protocol based on input from the FDA and its Pre-IND filing. The company said it plans to file an IND application with its completed protocol before the end of July.
The planned Phase II trial (NCT04333472) is a pilot trial in a population of hospitalized patients diagnosed with “moderate” COVID-19, and who all receive standard supportive care. Forty patients will be randomly assigned 1:1 to either Piclidenoson 2 mg twice daily or placebo, and treated for up to 28 days. The trial will assess efficacy through standard measures of clinical and respiratory status at Day 29, including the proportion of patients alive and free of respiratory failure, as well as the proportion discharged home without need for supplemental oxygen, Can-Fite said.
Safety and pharmacokinetic data will also be collected fpr Piclidenoson, which according to Can-Fite has been dosed in more than 1,000 patients in clinical studies for the treatment of rheumatoid arthritis and psoriasis.
In April, Can-Fite received approval from the Institutional Review Board (IRB) at Rabin Medical Center to initiate a pilot clinical study of Piclidenoson for the treatment of moderate-to-severe symptoms in COVID-19 patients. Upon review, the IRB recommended that Can-Fite advance into a full clinical study. Can-Fite submitted the study protocol, which has been approved by the IRB.
Patient enrollment and dosing will begin immediately for the trial, a randomized, open-label, 2-arm study of Piclidenoson plus standard supportive care, compared to standard supportive care alone, in 40 hospitalized COVID-19 infected patients with moderate-to-severe symptomatic disease. Patients will be randomized 1:1 to one of the trial arms and treated for up to 4 weeks. Key efficacy measures include time to resolution of viral shedding, time to resolution of clinical symptoms, measures of respiratory function, need for ventilatory support, and overall mortality, Can-Fite said.
The trial’s principal investigator is Dror Diker, MD, Head of Internal Medicine D at the Rabin Medical Center.
Piclidenoson is also being developed for autoimmune inflammatory diseases. 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.
COVID-19: 200 Candidates and Counting
To navigate through the >200 potential therapeutic and vaccine options for COVID-19, GEN has grouped the candidates into four broad categories based on their developmental and (where applicable) clinical progress:
● FRONT RUNNER – the most promising therapeutics/vaccines based on clinical progress, favorable data or both.
● DEFINITELY MAYBE – earlier phases with promising partners, or more advanced candidates in development that have generated uneven data.
● KEEPING AN EYE ON… – interesting technology, attracting notable partners, or both, but preliminary data.
● TOO SOON TO TELL – longshots pending additional experimental and/or clinical data.
GEN has also tagged the most common treatment types: