According to a recent phase 2a randomized clinical trial, PF-07038124, a topical PDE4 inhibitor, is an effective and well-tolerated treatment for patients with atopic dermatitis (AD) and plaque psoriasis.
“Topical PF-07038124 is designed to be a potent, oxaborole-based PDE4 inhibitor with immunomodulatory activity in T-cell–based assays, contributing to inhibition of IL-4 and IL-13; thus, it could provide therapeutic benefit in the treatment of AD and plaque psoriasis. The aim of this study was to assess the efficacy, safety, tolerability, and pharmacokinetics of topical PF-07038124 in patients with mild to moderate AD or plaque psoriasis.”
The trial included 104 patients; 70 presented with AD and 34 with plaque psoriasis. Patients were randomized (1:1) to PF-07038124, 0.01%, topical ointment or vehicle to be administered once a day for six weeks.
The primary endpoint of the study was the percent change from baseline (CFB) in the Eczema Area and Severity Index (EASI) score for those with AD and in the Psoriasis Area and Severity Index (PASI) score for those patients with plaque psoriasis at week six. The study also evaluated any treatment-emergent adverse events, which included any application site reactions.
Results from the study revealed that by week six, the group given PF-07038124 showed significantly greater improvement in both the EASI and PASI scores when compared to the vehicle group.
For the AD group, the proportion of patients achieving EASI-75 was significantly higher in the PF-07038124 group compared with the vehicle group from week two and this was maintained at week six. Furthermore, a significantly greater proportion of patients achieved an IGA score of clear (0) or almost clear (1) and a reduction from baseline of at least 2 points in the PF-07038124 group compared with the vehicle group at week six.
For the plaque psoriasis group, patients receiving PF-07038124 demonstrated a statistically significantly greater CFB in PASI total score compared with the vehicle group. Additionally, a statistically significantly higher proportion of patients achieved PASI-75 at week six in the PF-07038124 group compared with the vehicle group.
The study recorded adverse events in 27 patients which included nine from the AD treatment group, nine from the AD vehicle group, three in the plaque psoriasis treatment group, and six in the plaque psoriasis vehicle group. Researchers found these to be comparable. Treatment-related adverse events were however only reported in the vehicle groups. Additionally, no patients in the PF-07038124 groups experienced application site pain or skin reactions.
Researchers concluded that “Treatment with PF-07038124 demonstrated superior efficacy, compared with vehicle, in patients with mild to moderate AD and plaque psoriasis. The study drug was well tolerated, with no treatment-related TEAEs or application site reactions reported in the PF-07038124 group. To confirm persistence of efficacy and the safety profile of PF-07038124, long-term data should be collected in larger studies.”
