After complying with the conditions given by the Danish Ethics committee in September, Nordic biotech Coegin Pharma has received the final approval for initiating the phase I/II COAK study in actinic keratosis patients. From the beginning of November, the company will begin patient recruitment, and thus take an important step towards developing a novel treatment for a disease with a large unmet medical need.
Cancer on its own is one of the leading causes of death, globally. However, putting additional pressure on healthcare systems are pre-cancerous diseases, of which there is still a distinct lack of awareness. One example is actinic keratosis (AK), a pre-cancerous condition of the skin. AK skin lesions are a sign of chronic inflammation caused by high exposure to harmful UV rays from the sun, and, if left untreated, they can develop into more serious diseases including squamous cell carcinoma (SCC), a cancer of the skin that is potentially life-threatening.
The lack of awareness around AK leads to a heavy burden on patients who ignore these lesions until it is too late and become cancerous. Meanwhile, the most common treatment for the condition is cryotherapy – a freezing off of the lesion through liquid nitrogen that can lead to scarring, blisters, or other permanent changes to the skin. Therefore,new innovative therapies are in high demand.
Coegin Pharma address AK
A biopharma company addressing this challenge is Coegin Pharma, with a business model based on efficient development of new drug candidates for diseases with an urgent medical need where the cPLA₂α enzyme is central to disease progression. This includes AK. Thus, through several years of well-validated research, the cPLA₂α enzyme has become a therapeutic target for the company, and AVX001 was developed as a compound able to block cPLA₂α, thus becoming the company’s lead candidate for actinic keratosis and skin cancer.
Read more about the company’s background and vision here.
Planning for the COAK study
The company has been planning a combined phase I/II trial with AVX001 in AK called the Copenhagen Actinic Keratosis Study (COAK study). One of the most important steps to prepare for this trial has been partnering with the virtual CRO Studies&Me – the first virtual CRO in Europe.
Thanks to the collaboration with Studies&Me, the COAK clinical trial will be conducted with a decentralised approach, which is based on digital tools designed to put the patients front and centre. The patients will receive guidance and support, and they will be able to report back to the hospital from the comfort of their homes, reducing the number of physical visits to the hospital.
Read more about the collaboration in this in-depth joint BioStock Q&A with Coegin Pharma’s CEO Tore Duvold and Studies&Me’s CEO John Zibert.
Approval from the Danish Authorities
Earlier this year, Coegin filed for approval to initiate COAK from the Danish authorities. The Medicines Agency in Denmark gave its approval earlier this summer, however the company still required the approval from the Ethics Committee before it could begin the study.
A conditional approval from the Ethics Committee arrived in September. This approval entailed that Coegin would need to make small adjustments to patient information. BioStock was able to get in touch with Tore Duvold, who answered some questions about the meaning of the conditional approval. Read more here.
After complying with the conditions given by the Ethics Committee, the company has now announced receiving full approval and thus has the official green light to initiate the study.
Details of the study
The company expects COAK to present top-line results towards the end of Q1, 2022. The study will include at least sixty patients divided into three groups receiving two different strengths of AVX001 or placebo in the form of a cosmetically attractive gel formulation. The patients will be administering the treatment themselves once daily for four weeks and will be assessed up to eight weeks after end of treatment. The primary endpoints are safety and tolerability, and the secondary endpoints are efficacy and quality of life.
The COAK trial will be conducted at Bispebjerg Hospital by lead investigator Professor Merete Hædersdal, who answered some questions about the trial and the overall clinical development of AVX001 in a recent BioStock interview.
Exciting time for Coegin
Overall, this is a very important step for the company and its vision of potentially introducing a novel treatment for patients suffering from pre-cancerous conditions like AK and other diseases where the cPLA₂α enzyme plays a key role, such as some forms of cancer as well as chronic inflammatory diseases like arthritis and fibrosis.
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.