Klisyri ( Tirbanibulin ) is a novel microtubule inhibitor, indicated for the topical treatment of actinic keratosis ( AK ) and it acts through a selective antiproliferative mechanism of action.
The positive CHMP opinion is based on the results from two pivotal phase III clinical trials which have demonstrated complete clearance of AK lesions at day 57 in treated face or scalp areas in a significantly higher number of patients than with vehicle, together with a very acceptable tolerability profile.
Tirbanibulin represents a significant step forward in the treatment of actinic keratosis due to its short treatment protocol ( once daily application for 5 days ), proven efficacy and safety profile with very acceptable local tolerability.
The CHMP opinion is based on two phase III studies ( KX01-AK-003 and KX01-AK-004 ) positive results. These two double-blind, vehicle-controlled, randomized, parallel-group, multi-centre phase III clinical trials, which included 702 patients from 62 clinical sites across the US, showed that application of Tirbanibulin ointment 1% ( 10 mg/g ) in adults with actinic keratosis on the face or scalp is effective and well tolerated.
Both phase III studies achieved their primary endpoint, which was defined as 100% clearance of the AK lesions at day 57 within the face or scalp treatment areas, each study achieving statistical significance ( p less than 0.0001 ) on this endpoint.
In the KX01-AK-003 study, complete clearance was observed in 44% of the patients treated with Tirbanibulin versus 5% for vehicle-treated groups.
In the KX01-AK-004 study, complete clearance was observed in 54% of the patients treated with Tirbanibulin versus 13% for vehicle-treated groups.
Local reactions were mostly mild-to-moderate erythema, flaking or scaling, application-site pruritus, and application-site pain that resolved spontaneously.
Actinic keratosis or solar keratosis is a chronic and precancerous skin disease that occurs primarily in areas that have been exposed to ultraviolet ( UV ) radiation for a long period of time. It is usually found on the face, ears, lips, bald scalp, forearms, the posterior part of the hands, and lower legs. It is not possible to predict which AK lesions will develop into squamous cell carcinoma ( SCC ).
Actinic keratosis is one of the most common diagnoses in dermatology practices and data available suggests that its prevalence can be calculated to be around 18% of the population in Europe. ( Xagena )
Source: Almirall, 2021