ReCode Therapeutics chooses Denmark for EU clinical trials: A journey fuelled by efficient regulatory support
San Francisco ReCode Therapeutics is a clinical-stage genetic medicines company using precision delivery to power the next wave of mRNA and gene correction therapeutics. ReCode’s Selective Organ Targeting (SORT) lipid nanoparticle (LNP) platform enables highly precise and targeted delivery of genetic medicines directly to the organs and cells implicated in disease, enabling improved efficacy and potency.
Recode Tx has a pipeline of rare disease therapeutics and is planning to initiate their first clinical trials in the EU in 2024. In particular, Recode Tx are exploring EU sites for the conduct of a Phase 1 study to evaluate their mRNA-based LNP therapy for patients with Primary Ciliary Dyskinesia caused by mutations in the DNAI1 gene. With Denmark being home to one of the leading researchers in the field, Professor Kim G. Nielsen from Copenhagen University hospital (Rigshospitalet), it made sense for ReCode Tx to partner closely with Dr. Nielsen to design a trial for PCD patients with mutations in the DNAI1 mutation that could begin Europe.
As the company were preparing the study protocol, they were looking at an opportunity to consult with the Clinical Trials Unit at the Danish Medicines Agency (DKMA).
“We had some very specific regulatory questions and much to our surprise, we were able to have an informal conversation with the Danish Medicines Authority within a very short time frame. This interaction was extremely helpful in that all of our questions were answered and we were able to move forward without delay.”
The Danish Medicines Agency aims to ensure timely reviews with high standards while at the same time developing guidelines that support the conduct of tomorrow’s clinical trials. The agency is open for dialogue with partners and stakeholders, as they recognize that collaboration and dialogue is the best way to improve options for patients.
“Together with the other players in the Danish clinical trial ecosystem, we strive to put the patient at the core of research by involving their perspectives so that together we can position Denmark firmly in Europe when it comes to future methods and innovation within clinical research, such as decentralized clinical trials.”
Accelerating clinical trials is important to swiftly providing new treatments, especially for life-threatening conditions. Speedier trials save lives, reduce costs, offer a competitive edge, and contribute to scientific progress. Regulatory support and ethical considerations also favor expeditious development, but it's crucial to balance speed with rigorous research to ensure safety and reliability.
“Denmark offers a robust system for conducting clinical trials and we are excited to be assisting companies like ReCode Therapeutics to get started. At Invest in Denmark, our experts in Denmark and around the world are ready to assist similar companies connect with investigators and navigate the process of starting a clinical trial.”
Invest in Denmark is part of the Ministry of Foreign Affairs and has experts located around the world ready to provide free and confidential advice to companies looking to accelerate their business through activities in Denmark – including clinical research.