Pulmonary Embolism in Open Label Extension Trial of Deuruxolitinib Stops 12 mg BID Arm

Further Study of 12 mg BID Dose of Deuruxolitinib Unlikely

Deuruxolitinib (formerly known as CTP 543) is a JAK 1/2 inhibitor being studied for alopecia areata. It’s not yet approved, but the company hopes to pursue FDA approval soon.

The phase 3 THRIVE AA1 and THRIVE AA2 trials showed that it deuroxolitinib was helpful for alopecia areata. the THRIVE AA1 trial was a randomized, doubled blind placebo controlled trial with 706 patients with severe AA. THRIVE AA2 had 517 patients. Patients in these studies were randomized to either deuruxolitinib 12 mg twice daily, 8 mg twice daily or placebo.

By week 24, about 40 % of patients in the 12 mg twice daily group achieved excellent regrowth (defined as a SALT score less than or equal to 20) and 30 % in the 8 mg twice daily group achieved this target.

Pulmonary Embolism in 12 mg BID Group Leads to Major Shift in Deuruxolitinib Dosing Plan

Yesterday, I read an announcement that the FDA paused the use of deurixolitinib 12 mg twice daily due to the development of pulmonary embolism  in patient receiving 12 mg twice daily dosing  in one of the long-term studies. The company has stated that patients currently enrolled in clinical trials receiving 12 mg twice daily will have that dose stopped and patients will be now switched to 8 mg twice daily.  Given that there have been no thrombotic events reported to date for the 8 mg BID dose and US FDA has not placed the 8 mg BID dose on hold.

This is a big change for the drug given that the 12 mg BID dose was more effective than the 8 mg BID dose. More studies are needed to see how much regrowth happens in deuruxolitinib users after 52 weeks.

References

https://ir.concertpharma.com/news-releases/news-release-details/concert-pharmaceuticals-reports-positive-topline-results-first. Accessed Jan 14 2023.

https://ir.concertpharma.com/news-releases/news-release-details/concert-pharmaceuticals-reports-positive-topline-results-second. Accessed Jan 14. 2023

https://www.fortuneindia.com/enterprise/us-fda-halts-sun-pharmas-trial-on-dermatological-drugs-stock-down/112514 accessed May 2 2023