Summary
Can-Fite is progressing well with its lead product candidate.
The company has several milestones in 2018.
Cash position is weak.
Can-Fite Biopharma (CANF) is an Israel-based biopharmaceutical company with a late-stage pipeline. The company’s lead product candidate piclidenoson is currently in Phase 3 trial in two indications (rheumatoid arthritis or RA and moderate-to-severe plaque psoriasis). It has a second product candidate, namodenoson, currently in Phase 2 study in advanced liver cancer. Can-Fite is also developing namodenoson in NASH. The company has seen positive newsflow in recent months and yet its shares are trading at under $2. This is a good time to pick up Can-Fite as the company is progressing towards commercializing lead product candidate in Europe.
Piclidenoson Progressing In Phase 3
In the final quarter of 2017, Can-Fite announced that it enrolled first patient in the ACRobat Phase 3 trial of piclidenoson in RA. The trial is evaluating Can-Fite’s lead candidate in a first-line setting to replace methotrexate (MTX) for RA. While MTX is the standard of care in RA, the drug causes side effects and patients also develop intolerance. According to Can-Fite, around 50% of RA patients discontinue with MTX due to these reasons. This has created a continuous need for new treatment in the RA space.
Earlier this month, Can-Fite gave a presentation at the JPMorgan Healthcare Conference and notified investors that the Phase 3 study in RA is continuing to enroll patients. The data from the trial will be used to file a marketing application in Europe. In Phase 2b trial, piclidenoson met all the primary efficacy endpoints, achieving ACR20 at 12 weeks of 49%, compared to 25% for placebo with a p-value of 0.035. The ACR20 response rate is in-line with what has been reported with other approved disease modifying therapies in RA and significantly better than what has been reported with MTX alone in the past.
If the results from the Phase 2b trial can be replicated in the Phase 3 study, Can-Fite stands a strong chance of turning into a commercial biopharma company. The company already has several licensing deals in place for piclidenoson, including in Korea and Canada.
