Can-Fite BioPharma has announced the completion of its Phase 2/3 clinical trial evaluating Piclidenoson (CF101) as an oral treatment for moderate to severe psoriasis. The results show that Piclidenoson is both safe and potentially more effective than Otezla (apremilast), an approved treatment for plaque psoriasis patients.
The study detailing the trial’s outcomes, “Treatment of Plaque-Type Psoriasis With Oral CF101: Data from a Phase II/III Multicenter, Randomized, Controlled Trial,” was published recently in the Journal of Drugs in Dermatology.
“There is a clear need for an effective, oral drug for moderate to severe psoriasis that maintains its efficacy, while also having a favorable safety profile. We believe Piclidenoson is a strong candidate to meet this need,” Pnina Fishman, CEO of Can-Fite, said in a press release.
Maintained efficacy would be a key advantage, since nearly 70 percent of biological treatments for moderate to severe psoriasis are discontinued due to the loss of efficiency over time, or to deleterious side effects.
Although Piclidenoson did not meet the study’s primary efficacy endpoint at week 12 — 75 percent or greater improvement in the Psoriasis Area Severity Index (PASI 75) — improvement was observed in patients as early as week 24 and was statistically significant at week 32, when the trial concluded. These results suggest that the efficacy of Piclidenoson continues to improve over time, whereas Otezla (marketed by Celgene) appears to reach a plateau in efficacy beyond week 16, Can-Fit said in the release.
Piclidenoson is an oral drug that acts as an activator of the A3 adenosine receptors (A3ARs), which mediate anti-inflammatory protective effects in the cells by inhibiting the inflammatory cytokines, interleukin 17 (IL-17) and interleukin 23 (IL-23), known to participate in the process of psoriasis.
“Oral CF101 was found to be safe and very well tolerated, demonstrating evidence of efficacy in patients with moderate to severe plaque psoriasis through 32 weeks of treatment,” the study’s authors concluded.
The company is expected to soon start a Phase 3 test, evaluating the efficacy and safety of the twice-daily oral administration of Piclidenoson, compared to Otezla, in psoriasis patients for 32 weeks. The results are expected to confirm whether Piclidenoson is indeed a safer and more durable option for the treatment of moderate to severe psoriasis.