Can-Fite Advances Namodenoson in Liver Cancer and Piclidenoson in Psoriasis

Can-Fite BioPharma is advancing both lead candidates, namodenoson and piclidenoson, through Phase III development, with namodenoson carrying FDA Fast Track and U.S. and European Orphan Drug designations. The regulatory status establishes defined development pathways for potential approvals in the U.S. and Europe.

Namodenoson Targets Advanced Liver Cancer

Namodenoson is an oral A3 adenosine receptor (A3AR) agonist being evaluated in a pivotal Phase III study (NCT05201404) for patients with advanced hepatocellular carcinoma (HCC) and underlying Child-Pugh B7 cirrhosis. The study is being conducted under FDA and EMA regulatory guidance and is intended to support potential marketing applications in both regions if it meets its prespecified efficacy and safety endpoints.

The candidate holds FDA Fast Track designation for second-line HCC treatment and Orphan Drug designations in both the U.S. and Europe. These designations provide regulatory benefits for development in a disease setting with significant unmet medical need.

Beyond HCC, namodenoson is also being studied in a Phase 2b program (NCT04697810) for metabolic dysfunction-associated steatohepatitis (MASH) and a Phase 2a study (NCT06387342) in pancreatic cancer. The company has reported proof-of-concept findings in additional cancer types, including colorectal, prostate, and melanoma, although these earlier findings do not establish clinical efficacy for those indications.

Piclidenoson Moves Forward in Psoriasis

Piclidenoson, another oral A3AR agonist, is being evaluated in a Phase III program (NCT06643260) for moderate-to-severe plaque psoriasis. The program represents Can-Fite’s second lead late-stage development effort alongside namodenoson in HCC.

The company previously reported topline results from a Phase 3 psoriasis trial and has since commenced a pivotal Phase 3 study. The supplied announcement does not provide detailed efficacy, endpoint, statistical, or safety results from that earlier study, so the current update does not establish the candidate’s clinical benefit in psoriasis.

Regulatory Pathways Define Next Development Steps

Can-Fite said both programs are progressing under regulatory frameworks established with the FDA and EMA. For namodenoson, the combination of Fast Track and Orphan Drug designations adds regulatory support as the company advances the pivotal HCC program.

Dr. Pnina Fishman, Can-Fite’s chief scientific officer and executive chairperson, said the two Phase III programs and established U.S. and European regulatory pathways provide greater clarity around development and potential approval routes.

Future Direction

The immediate clinical priority is the continued execution of the Phase III HCC study of namodenoson and the Phase III psoriasis program for piclidenoson. Potential regulatory submissions will depend on whether the respective trials meet predefined efficacy and safety criteria.

The company reports that more than 1,600 patients have received its drug candidates across clinical studies and describes the programs as having an established safety experience. However, the current update does not provide indication-specific safety data from the ongoing Phase III trials.

For now, the significance of the update lies primarily in development maturity and regulatory positioning rather than new clinical efficacy data. Both candidates have reached late-stage testing, while namodenoson has secured regulatory designations that could facilitate its path toward potential approval in HCC.

 Reference

Can-Fite Highlights Advanced FDA and EMA Regulatory Status of its Phase III Drug Candidates