Topical Actinic Keratosis Treatment Launched in US

Almirall announces the launch of its novel microtubule inhibitor tirbanibulin (Klisyri, Almirall) for the topical treatment of actinic keratosis (AK) on the face or scalp, according to a press release from the company.¹

"The U.S. launch of Klisyri marks another important milestone for Almirall toward our goal to be a leader in the field of dermatology and deliver new, innovative and effective treatment options," said Pablo Alvarez, president and general manager of Almirall U.S. "We are committed to providing patients with affordable access to our medications, and we have a copay card and a network of pharmacies covering the country to support this. We are excited to be able to offer this novel treatment option for dermatologists and their patients."

Tirbanibulin was approved by the FDA in December 2020. This decision is supported by recently published results from two double-blind, vehicle-controlled, multi-center, parallel-group, randomized, phase 3 clinical trials (KX01-AK-003 and KX01-AK-004) which examined the efficacy and safety of tirbanibulin ointment 1% (10 mg/g) in adults with AK on the face or scalp.

As previously reported by Dermatology Times, both studies met the primary endpoint of complete (100%) clearance of AK lesions by Day 57 within the face or scalp treatment areas. Notably, each study achieved a highly statistically significant result (p<0.0001).

Results of KX01-AK-003 demonstrated a complete clearance in 44% of tirbanibulin patients compared to 5% of patients treated with vehicle. Meanwhile, in the KX01-AK-004 study, 54% of tirbanibulin patients achieved complete clearance versus 13% vehicle.

"The incidence of actinic keratosis has been increasing, including in younger adults,” said Ayman Grada, MD, head of R&D and medical affairs at Almirall U.S. “Patients may prefer a treatment option with a short duration and proven safety and tolerability profile. The data for Klisyri offers this, as well as demonstrating efficacy for both face and scalp actinic keratoses."

Additionally, tirbanibulin achieved the secondary endpoint in both studies, which is defined as partial (≥75%) clearance of lesions (68% of tirbanibulin vs. 16% vehicle in KX01-AK-003, and 76% vs. 20% in KX01-AK-004). Again, results from both studies were highly statistically significant (p<0.0001).

Safety data from both studies was also favorable, with mild-to-moderate local skin reactions occurring and resolving without intervention. They saw no patient withdrawals from the phase 3 studies due to treatment-related adverse events.

“Klisyri will help address unmet needs for many AK patients," said George Martin, MD. "Early diagnosis and a safe and highly effective topical for treatment of actinic keratosis is critical. Patients with actinic keratoses are at higher risk for developing non-melanoma skin cancer. Actinic keratosis can progress into squamous cell carcinoma (SCC), a common and sometimes invasive and deadly form of skin cancer."

Full prescribing information for tirbanibulin can be found here.

Reference:

1. Almirall. Almirall u. S. Launches klisyri®(Tirbanibulin) , a new, innovative topical treatment for actinic keratosis. Accessed February 23, 2021. https://www.prnewswire.com/news-releases/almirall-us-launches-klisyri-tirbanibulin-a-new-innovative-topical-treatment-for-actinic-keratosis-301230528.html