Pfizer has revealed that its investigational Janus kinase 1 (JAK1) inhibitor, abrocitinib, has met its co-primary efficacy endpoints in a Phase III moderate to severe atopic dermatitis trial.
Data from the JADE COMPARE trial also showed that the safety and efficacy of the drug were proved in patients who were on background topical therapy for the disorder. Going forward, Pfizer says that the data, along with other results from other pivotal trials, MONO-1 and MONO-2, will support filings with regulatory bodies, starting with the US Food and Drug Administration (FDA) planned for later this year.
Results showed that the percentage of patients achieving each co-primary efficacy endpoint at Week 12 was statistically superior with both doses of abrocitinib than with placebo, and that superiority to placebo with both doses was maintained at Week 16.
As a key secondary endpoint, the percentage of patients who had a clinically significant reduction in itch by Week 2 of treatment was statistically superior for the 200mg abrocitinib dose than dupilumab.
“It was helpful to study abrocitinib in combination with topical therapies to provide data relevant to the real-world setting,” commented Michael Corbo, chief development officer, inflammation & immunology, Pfizer Global Product Development.
He continued, “The addition of an active control was also important to better understand the significance of this potential new medicine and we’re encouraged by the positive data from this trial.”
The company says that the full results from JADE COMPARE will be submitted for presentation at a future scientific meeting and publication in a medical journal.