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Phase 3 enrollment to begin for Piclidenoson in treatment of RA
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Can-Fite BioPharma Ltd. announced it will begin phase 3 trial enrollment in the second quarter of 2017 for its lead drug candidate Piclidenoson as a first-line treatment for patients with rheumatoid arthritis, according to a company press release.
“We are eager to commence our phase 3 rheumatoid arthritis trial in the second quarter,” Pnina Fishman, PhD, chief executive officer of Can-Fite BioPharma, said in the release. “We believe Piclidenoson can offer a superior alternative to [methotrexate] MTX, which is used at some point by approximately 90% of rheumatoid arthritis patients.”
The randomized, double-blind, placebo-controlled trial — called Acrobat — will cost about $5 million and will enroll 500 patients in Europe, Canada and Israel to be treated orally with Piclidenoson, an A3 adenosine receptor agonist small molecule. The primary endpoint will be low-disease activity after 12 weeks in the Piclidenoson group compared with the MTX group. Patients will receive Piclidenoson or placebo twice per day in 1-mg or 2-mg regimens or MTX or placebo once per week. In total, the study will last 24 weeks.
Also in 2017, Piclidenoson will enter a phase 3 trial as treatment for patients with psoriasis.
“MTX is an oncology drug known to induce severe adverse events,” Fishman said. “Piclidenoson’s well established and excellent safety profile, as demonstrated in previous clinical studies in more than 1,000 patients, combined with a potential for efficacy equal to or better than MTX, positions Piclidenoson as a potential future first-line therapy of choice for doctors treating rheumatoid arthritis.”
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