Actinic keratosis

About actinic keratosis

Actinic keratosis is sun damage to the skin caused by excessive sun exposure during the course of life. It is a very common precursor to skin cancer. Actinic keratosis is considered a chronic disorder, where the majority of patients experience recurrent lesions over time. Actinic keratosis increases the risk of developing skin cancer, as it may develop into squamous cell carcinoma (SCC), a common and sometimes invasive skin cancer. The incidence is highly correlated with the cumulative lifetime exposure to ultraviolet (UV) radiation from sunlight, and although it may occur at the age of 20-30, it is far more common in patients over 50 years of age.

Actinic keratosis is an early precursor to squamous cell carcinoma, a malignant skin tumor that develops from the keratinizing cells (keratinocytes) in the epidermis or skin adnexa. Because of the risk that actinic keratosis develops into SCC, treatment is generally recommended. There is a great unmet need for better therapeutic options for actinic keratosis with regard to treatment effect, side effects and treatment duration. The disease is mainly treated repeatedly with cryotherapy, photodynamic therapy or topical agents.

Phase I/II trial in actinic keratosis

In cooperation with Studies&Me, Coegin Pharma will conduct a double-blind placebo-controlled combined Phase I/II trial led by Professor Merete Hædersdal, responsible clinician at Bispebjerg Hospital in Copenhagen.

Patients suffering from actinic keratosis will be recruited to the trial and treated with the drug candidate AVX001 in different doses. The purpose of the trial is to evaluate the product's safety and efficacy over a shorter duration of treatment, which further involves a digital, patient-centric approach. In March 2021, Coegin Pharma submitted an application to the Danish research ethics committee and the Danish Medicines Agency with the aim of starting a clinical trial in August 2021. The trial is expected to be completed in 2021, and results would then be presented in early 2022. The aim of the trial is to develop a new topical drug that meets all safety requirements and delivers a treatment effect that satisfies the patients’ need for safe, effective and convenient treatment of their disease.

Market overview

In 2018, the global market for actinic keratosis was estimated to more than 6 billion USD, with an estimated CAGR growth of approximately 4 percent until 2026. Of this market, cryotherapy and photodynamic therapy currently represent approximately 40 percent. Coegin Pharma is looking to position itself on the market with a safer, more effective treatment where the duration of treatment is significantly shorter than with the currently available methods. Such a product profile is anticipated to gain a significant market share from the existing products, but also, to a large extent, from traditional cryotherapy with an estimated annual global sales worth of USD 200–400 million.

Studies&Me

Studies&Me is a virtual contract research organization (V-CRO) focusing on the digitalization and personalization of clinical research, including through the use of digital means to enable patients to conveniently participate in clinical trials from their own homes. Studies&Me was established in 2016 as a digital platform to facilitate the online recruitment of patients to LEO Pharma’s digital innovation unit, LEO Innovation Lab. In August 2020, Studies & Me was spun off as an independent company. The goal was to set a new standard for clinical research by unlocking the potential of novel health technologies and the increasing amount of data that we all generate. Studies & Me cooperates with partners all over the world to achieve a global impact and contribute to a health revolution in pharmaceutical development.