The market for ulcerative colitis (UC) is filled with a number of different treatment options, and the pipeline is relatively strong. Pfizer’s etrasimod is a notable agent in the late-stage UC pipeline which is a once-daily oral sphingosine-1-phosphate (S1P) modulator. The company recently presented long-term safety data spanning 2.5 years at the Digestive Disease Week (DDW) 2023. The key takeaway from this presentation was that etrasimod was well-tolerated with a safety profile that appears to be stable with longer-term treatment of up to 2.5 years. This data could help strengthen etrasimod’s profile, says GlobalData, a leading data and analytics company.

Ramla Salad, Pharma Analyst at GlobalData, comments: “Etrasimod’s favorable long-term safety data will be crucial for its clinical positioning as Pfizer will want to lean on this data to alleviate the concerns regarding cardiac adverse events associated with the S1P modulator drug-class. Presenting this data will also be crucial for Pfizer to bolster the agent’s position against first-to-market S1P receptor modulator for UC, BMS’ Zeposia.”

As a note, BMS also presented similar safety analyses at the European Crohn’s and Colitis Organization (ECCO) 2023 conference.

Salad continues: “This presentation will likely help increase physician confidence in the asset and further strengthen BMS’s position in the UC therapy space, as competition for second line treatment is expected to intensify with the impending arrival of etrasimod.”

According to GlobalData’s report, “Ulcerative Colitis: Eight-Market Drug Forecast and Market Analysis,” the UC market is forecasted to reach sales of approximately $9.6 billion across the 8MM in 2031, with 8% of this sales value anticipated to come from the S1P class, translating to a value of $797.4 million; over half of those sales are anticipated to come from etrasimod.

The key opinion leaders (KOLs) interviewed by GlobalData mentioned that although S1P modulators such as Zeposia and etrasimod provide another option for patients, there is still a lot to learn about the MOA.

Salad concludes: “It is expected that Pfizer will continue to collect long-term safety data from the ongoing open-label extension Phase III ELEVATE UC OLE study to generate supporting data to leverage at future conferences to bolster etrasimod’s perception as a safe oral therapy in UC. GlobalData anticipates etrasimod will enter the US market in 2024 but given its late entrance into a crowded UC market, etrasimod will likely need to demonstrate both efficacy and safety benefits over its direct competitor, Zeposia.”