Nordic biotech Coegin Pharma reached a key milestone this summer by receiving the green light from the Danish Medicines Agency to begin the Copenhagen Actinic Keratosis Study with lead candidate AVX001. Now, the company has also received a conditional approval from the Ethics Committee, meaning that the clinical trial will be initiated after making slight adjustments to patient information material. BioStock spoke with Coegin’s CEO Tore Duvold to discuss what this all means.
As described in a recent BioStock interview with Coegin Pharma’s co-founder of the company, Professor Berit Johansen, the cPLA₂α enzyme was first discovered to play a key role in the cellular communication that leads to inflammation and cancer. After further research to learn more about this target, the company, developed a drug candidate, AVX001, able to block cPLA₂α, and eventually proof-of-concept was obtained in psoriasis – another chronic inflammatory disease.
Since then, Coegin has shifted its focus from psoriasis to cancer, and the company has been planning a combined phase I/II trial called Copenhagen Actinic Keratosis Study (COAK study) with AVX001 in actinic keratosis (AK), a precancerous skin condition. The study 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.
COAK study approved by Danish authorities
This summer, Coegin achieved a very important milestone in the project, as the Danish Medicines Agency approved the company’s request to initiate the trial. In the company’s 2021 Q2 report, released in late August, CEO Tore Duvold pointed out that trial initiation still needed the green light from the Danish Ethics Committee, which was experiencing administrative delays.
At last, the company announced last week that it had received a conditional approval for initiating the COAK study from the Ethics Committee. This means that after the company makes some adjustments in the patients’ information, the trial can be initiated. The company judges these conditions to be minor and not affecting the design and duration of the study.
»The questions we have received are reasonable and manageable and they will not affect the study. We therefore expect that we can start patient recruitment very soon and present the results in the beginning of 2022.« — Tore Duvold, CEO Coegin Pharma
Learning more from the CEO
To better understand what this conditional approval means, BioStock reached out to Coegin Pharma’s CEO Tore Duvold.
Tore Duvold, after some processing delays, the Danish Ethics Committee followed the Danish Medinces Agency in approving the COAK study, which Coegin has been working so hard to prepare for. However, the approval from the Ethics Committee is conditional. Could you explain to our audience what a conditional approval means?
– This is a completely normal procedure form the ethics committee. In most cases they will ask the companies for changes in order to give the final approval. The changes can be fundamental but in this case they are not. The questions we have received are reasonable and manageable and they will not affect the study. We therefore expect that we can start patient recruitment very soon and present the results in the beginning of 2022.
What exactly are the conditions of the approval?
– The comments are related to the patient information material where we have been asked to change some wordings which could be perceived as biased, how we refer to previous clinical studies, more information about the first patient visit and clarification about data privacy. The demands are sound, we can address them quickly and they do not impact the design and overall timeline.
How will this affect the original timeline put in place for trial initiation and release of topline data?
– We still expect to keep the overall timeline. As we previously communicated, there has been a general administrative delay in the ethics committee which has nothing to do with our study. The delay means that our study start is postponed by approximately one month. We have used the time wisely to prepare all practical aspects of the study. Due to the very efficient set up based on digital tools, online recruitment, remote monitoring, etc, we feel confident that we can keep our original timeline. I think it is fair to say that this is an exceptional trial with regard to both the innovative design and time efficiency.
Finally, could you speak to the overall importance of reaching this key milestone?
– The two approvals are our licence to conduct the clinical trial and are therefore essential milestones. We are of course very satisfied that both authorities have approved our study despite the need for minor updates in the patient information material. We have teamed up with some of the best professionals in dermatology and skin cancer for the study and we have provided high quality documentation and an excellent patient centric clinical design. We are confident that we have provided the best possible ground for this trial in a common disease with an urgent need for better treatments. We are ready and we very much look forward to start recruiting patients.
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.