Positive phase 3 results for psoriasis antibody injection support NDA submission in China

Key takeaways:

• Picankibart is a recombinant anti-interleukin 23p19 subunit antibody injection for moderate to severe psoriasis.
• Picankibart met all primary endpoints and key secondary endpoints in this phase 3 study.

A new antibody injection for the treatment of moderate to severe plaque psoriasis met all primary and key secondary endpoints in a phase 3 Chinese study, Innovent Biologics announced in a release.

Picankibart is a recombinant anti-interleukin 23p19 subunit antibody injection that prevents IL-23 from binding to cell surface receptors. It is currently under investigation in the CLEAR-1 global, phase 3 registration study for the treatment of moderate to severe plaque psoriasis.

According to the press release, the drug has produced rapidly effective improvements in psoriasis with more than 80% of subjects achieving a coprimary endpoint of PASI 90 after 16 weeks of treatment. The other coprimary endpoint was also reached, with more than 90% of subjects achieving static PGA 0 or 1.

A high proportion of patients treated with picankibart also achieved a DLQI score of 0 or 1 by week 16. Additionally, patients maintained their improvements through week 52.

“Achievement of all primary and key secondary endpoints in CLEAR-1 has supported picankibart’s outstanding efficacy and favorable safety as a new generation of IL-23p19 target drugs,” Lei Quian, MD, PhD, vice president of clinical development at Innovent, said in the release. “Moreover, picankibart can be administered only five to six times per year, adding convenience value as a new treatment option compared to the current mainstream marketed drugs (seven to 16 times per year).”

These recent phase 3 results support Innovent’s plan to submit a new drug application for picankibart for psoriasis treatment to China’s regulatory authority, the Center for Drug Evaluation of National Medical Product Administration.