Can-Fite BioPharma Advances Dual Phase III Programs with Namodenoson and Piclidenoson
核心洞察
Can-Fite BioPharma is conducting pivotal Phase III trials for Namodenoson in advanced hepatocellular carcinoma (搜索) patients with Child-Pugh B7 liver function, addressing a significant unmet medical need with no approved therapies.
The company is simultaneously running a Phase III study of Piclidenoson for psoriasis (搜索) treatment, with both programs expected to report interim data in Q4 2026 and Q2 2026 respectively.
Namodenoson demonstrates multi-indication potential with ongoing Phase IIb studies in MASH and Phase IIa trials in pancreatic cancer (搜索), following positive Phase IIa results showing anti-inflammatory, anti-steatotic, and anti-fibrotic effects.
Can-Fite BioPharma Ltd. is advancing two pivotal Phase III clinical programs targeting significant unmet medical needs in oncology and dermatology, with interim data readouts expected throughout 2026. The Israeli biotechnology company announced updates on its clinical development activities for lead drug candidates Namodenoson and Piclidenoson, positioning the company for potential regulatory submissions based on upcoming trial results.
Namodenoson Targets Underserved HCC Population
Can-Fite is currently enrolling patients in a pivotal Phase III clinical study evaluating Namodenoson for the treatment of advanced hepatocellular carcinoma (搜索) (HCC) in patients with Child-Pugh B7 liver function. This patient population represents a significant unmet medical need, as no approved therapies are currently available for this specific indication.
The Phase III study is expected to provide interim analysis data in approximately Q4 2026. Subject to positive interim results, the company may be eligible to seek conditional regulatory approval from the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).
Beyond the HCC indication, Namodenoson is being evaluated across multiple therapeutic areas. The company is enrolling patients in a Phase IIb clinical study for the treatment of metabolic dysfunction-associated steatohepatitis (搜索) (MASH), building on positive results from a completed Phase IIa trial. The earlier-stage study demonstrated anti-inflammatory, anti-steatotic, and anti-fibrotic effects, with data published in peer-reviewed literature.
Additionally, Namodenoson is being evaluated in a Phase IIa clinical study in patients with pancreatic cancer (搜索) who have failed first-line treatment. Patient enrollment in this study is nearing completion, and the company expects to report data during the second quarter of 2026.
Piclidenoson Phase III Program in Psoriasis
Can-Fite is currently enrolling patients in a pivotal Phase III clinical study evaluating Piclidenoson for the treatment of psoriasis (搜索). In this study, patients receive Piclidenoson orally, administered twice daily. The primary efficacy endpoints of the trial are PASI 75 (Psoriasis Area and Severity Index) and Physician's Global Assessment (PGA), consistent with regulatory guidance for late-stage psoriasis studies.
Based on the company's current assumptions, interim analysis data is expected to be released in the second quarter of 2026. The company has also completed the development of a Phase II study protocol for the rare genetic disease Lowe Syndrome (搜索) and plans to submit it to regulatory authorities in Italy and EMA during Q1 2026.
Financial Position and Strategic Outlook
As of June 30, 2025, Can-Fite had cash and cash equivalents and short-term deposits of $6.45 million. The company completed a public offering for aggregate gross proceeds of $5 million on July 28, 2025, and raised an additional $2.2 million through its ATM facility in November 2025.
"Our advancing clinical programs reflect Can-Fite's focused strategy of addressing significant unmet medical needs with orally administered, well-characterized drug candidates," said Motti Farbstein, Chief Executive Officer of Can-Fite BioPharma. "With pivotal Phase III studies ongoing in liver cancer and psoriasis (搜索), alongside progressing mid-stage programs in MASH and pancreatic cancer (搜索), we believe we are well positioned to generate meaningful clinical data over the coming quarters while maintaining disciplined execution."
The company's platform technology is designed to address multi-billion-dollar markets in the treatment of cancer, liver, and inflammatory diseases. Namodenoson has been granted Orphan Drug Designation in the U.S. and Europe and Fast Track Designation as a second-line treatment for HCC by the FDA. The drug candidates have demonstrated an excellent safety profile with experience in over 1,600 patients in clinical studies to date.