Phase III Cingal 19-01 Study demonstrates superiority in knee osteoarthritis pain relief

The Cingal 19-01 Phase III study is the third completed Phase III study of Cingal and, together with previous studies, has now demonstrated superiority over each of its active ingredients and placebo.

Across the three completed Phase III studies, Cingal demonstrated a mean 71% pain improvement from baseline and a mean 91% of Cingal subjects were deemed to be Responders.

Anika will engage with the FDA in the coming months on next steps for U.S. regulatory approval. In parallel, Anika is exploring the potential to advance Cingal through commercial partnerships in the U.S. and select Asian markets. These efforts will inform next steps, including if and how to proceed with another clinical trial in the United States.

The Cingal 19-01 Phase III study was a multicenter, randomized, double-blind, parallel group, placebo-controlled, active comparator study that evaluated OA subjects at 26 sites in the United States. In total, 231 subjects were randomized into three treatment arms (Cingal (99 subjects), TH steroid alone (99 subjects) and placebo (saline) (33 subjects)). Anika conducted the Cingal 19-01 Phase III study with the aim of de-risking the Cingal clinical development program by demonstrating that a study that was placebo-controlled and enrolled patients with a higher pain score at baseline would show superiority of Cingal over TH steroid at 26 weeks.