medwireNews: A phase 3 study comparing the A3 adenosine receptor agonist piclidenoson with methotrexate in people with early rheumatoid arthritis (RA) has been stopped early after failing to show noninferiority at interim analysis.
Pnina Fishman, from Can-Fite BioPharma in Petah Tikva, Israel, presented the findings in a poster at the ACR Convergence 2021 virtual meeting.
She explained that piclidenoson induces selective apoptosis of inflammatory cells and has previously shown safety and efficacy in phase 2 clinical trials in RA and psoriasis.
The current study included 252 methotrexate-naïve patients with early RA (mean duration 1.5 years) who were randomly assigned to receive piclidenoson 1 mg (n=72), piclidenoson 2 mg (n=73), methotrexate (n=73), or placebo (n=34) for up to 24 weeks. Piclidenoson and matching placebo tablets were given every 12 hours, while methotrexate and matching placebo capsules were given weekly.
Fishman noted that, due to the COVID-19 pandemic, enrollment was paused before reaching the target of 525 participants and an interim analysis was performed after 50% of participants had completed their week 12 visit.
The poster showed that approximately 13% of participants in the piclidenoson 1 mg group and approximately 15% of those in the piclidenoson 2 mg group achieved the primary endpoint of DAS28-ESR low disease activity at 12 weeks.
By comparison, the proportions were approximately 21% and 4% in the methotrexate and placebo groups, respectively.
These results in the per protocol population “do not support non-inferiority” of piclidenoson at either dose relative to methotrexate and intention-to-treat analysis did not show superiority over placebo, Fishman remarked.
She said that piclidenoson “had a highly favorable safety profile.” Treatment-emergent adverse event rates were similar between the groups, at 17%, 25%, 26%, and 29%, with piclidenoson 1 mg, piclidenoson 2 mg, methotrexate, and placebo, respectively.
Fishman therefore concluded that the study drug “was safe, but did not meet the primary endpoint in the current study.”
She added: “Since the primary endpoint was not met, the trial was discontinued by the sponsoring company.”
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ACR Convergence 2021; 3–9 November