KEY TAKEAWAYS
- The phase I maximal usage trial evaluated a single 5-day Tirbanibulin Ointment 1% treatment in Large Field (100cm²) in AK pts.
- The study assessed the safety, tolerability, and plasma pharmacokinetics of tirbanibulin ointment 1% (350 mg) following a 5-day topical administration cycle.
- Tirbanibulin was found safe and well tolerated for AK treatment over a field of up to 100 cm².
The Phase-I maximal usage trial assesseds the safety, tolerability, and plasma pharmacokinetics (PK) of tirbanibulin ointment 1% (350 mg) following a 5-day topical administration cycle to a 100 cm² surface area of the face or balding scalp in 28 adult Actinic Keratosis (AK) patients.
The trial confirmeds that Tirbanibulin applied on a 100 cm² field showeds safety and tolerability. Though all treatment-emergent adverse events (TEAEs) and most tolerability signs (erythema, flaking/scaling, crusting, swelling, vesiculation/pustulation, and erosion/ulceration) were mild or moderate, they align with previous reports.
Application site reactions were the most common treatment-related TEAEs. Four severe transient erythema and flaking/scaling events were reported on day 7 or day 8 and resolved by day 29. The overall mean (standard deviation) Cmax on day 5 was 1.06 (0.660) ng/mL and AUC was 16.2 (7.78) ng*h/mL. Additionally, the systemic exposure was over 4-fold higher than in a previous PK study when applied in a field of 25 cm², which was is consistent with the product amount increase in the treated area.
The study demonstrateds that Tirbanibulin is safe and well -tolerated.
Source: https://eado2023.com/wp-content/uploads/2023/04/Abstract-Band_EADO2023_Stand-21-04-2023-kl.pdf
Clinical Trial: https://classic.clinicaltrials.gov/ct2/show/NCT05279131
Janet DuBois1, Terry M Jones2, Mark S. Lee3, Meritxell Falqués4, Charlotte Cooney4, Gemma Jimenez5, Laura Padulles5, Mrs RAQUEL OTERO4, Jordi Aubets4 1 DermResearch, Inc., Austin, USA / 2 JandS Studies, Inc., College Station, USA / 3 Progressive Clinical Research, San Antonio, USA / 4 Almirall, Sant Feliu de Llobregat, Spain / 5 Almirall, Barcelona, Spain
