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There is a high demand for new innovative treatments against the precancerous skin condition actinic keratosis (AK). In the Nordics, Coegin Pharma is developing a drug targeting the cPLA₂α enzyme, which is involved in several inflammatory diseases, cancers and pre-cancerous conditions like AK. This week, the company submitted an application to the Danish Medicines Agency to begin a clinical trial with the drug candidate AVX001.

Actinic keratosis (AK) is one of the most common skin disorders and can be a first step in the development of skin cancer. It usually presents as small, rough, or scaly lesions caused by too much exposure to the sun, and many patients suffer from multiple lesions, which can be a significant burden to them, affecting quality of life. If left untreated, AK can develop into skin cancer, and those patients undergoing conventional AK treatments frequently experience pain, bleeding, inflammation, and scarring. Consequently, new and better treatment options to reduce patient side effects such as skin damage are in high demand.

Nordic biotech Coegin Pharma is developing a small molecule drug therapy, AVX001, that targets the cPLA₂α enzymean enzyme involved in a variety of inflammatory diseases, including several cancers, as well as pre-cancerous conditions like AK. Read more about Coegin Pharma and its vision here.

After 30 years of pioneering research led by Professor Berit Johansen at the Norwegian University of Science and Technology (NTNU) aimed at identifying the pro-inflammatory roles and signalling cascades of the cPLA2α enzyme, Coegin Pharma is now ready to take AVX001 to the clinic. The company has submitted an application for clinical trials (CTA) to the Danish Medicines Agency and to the Scientific Ethics Committee. The application is for a permit to start a clinical phase I/II study with AVX001 in AK. A response from the committees is expected within 90 days.

Coegin Pharma’s CEO Tore Duvold put his excitement about the application on display in a recent press release and is very much looking forward to the initiation of the trial: 

»I am very happy that we have submitted the application for the clinical study, and I look forward to being able to initiate it. We have great hopes that our product can help a lot of people suffering from actinic keratosis. Many perceive the existing treatment options to be difficult, unpleasant and time-consuming. We hope to be able to demonstrate the potential of our product and that in the future we will be able to offer patients a safe, effective and practical treatment. Studies & Me offers unique and innovative methods for clinical trials with the focus always on the patient. In concrete terms, their concept means it is much easier for both patients and clinicians to follow the treatment as the patients are continuously supported, monitored and guided digitally in their own homes.«

The double-blind, placebo-controlled, combined study will be run in collaboration with Contract Research Organisation Studies & Me, and led by Professor Merete Hædersdal (MD, PhD, DMSc) at Bispebjerg Hospital. BioStock was able to interview Professor Haedersdal to learn more about the clinical trial, and that interview can be found here.

The study is expected to begin (pending approval) in August 2021 and results presented in early 2022. BioStock looks forward to following Coegin Pharma’s journey to the clinic.

The content of BioStock’s news and analyses is independent but the work of BioStock is to a certain degree financed by life science companies. The above article concerns a company from which BioStock has received financing.

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