ECRAID-Prime expands trial with new antiviral treatment
ECRAID-Prime welcomes new investigational medicinal product (IMP) for COVID-19 and COVID-like illness in ongoing adaptive platform trial in in primary care.
ECRAID-Prime is pleased to announce the addition of a third candidate treatment – LTX-109 intranasal spray – to its adaptive platform trial, which is currently evaluating whether nitric oxide nasal spray and saline spray improve patient outcomes. The goal of the new Phase 2A study is to evaluate whether LTX-109 accelerates the clearance of viral pathogens in outpatients with COVID-19 and COVID-like illness.
“We are proud to welcome our third treatment arm as part of this ambitious trial in primary care,” says trial lead Alike van der Velden. “This is a milestone as we expand research on respiratory infectious disease in primary care, an area where we can make a huge impact during emerging outbreaks. Having a clinical research infrastructure in primary care is essential for enabling us to rapidly evaluate promising treatments at the point of need, thereby strengthening our pandemic preparedness.”
Promising Potential of LTX-109
The EU-funded trial, which aims to enrol approximately 1,200 patients in general practitioner clinics in Europe, is reaching its one-third mark in recruitment. With the addition of LTX-109, the ECRAID-Prime trial includes five parallel trial arms, evaluating three treatments for respiratory infections.
Owned by Pharma Holdings, the LTX-109 therapeutic agent targets pathogens in the nasal pathway and stops viruses from replicating. This helps to reduce the probability of viruses reaching the lower respiratory tract, thereby reducing the risk of a more serious infection. In earlier research, LTX-109 has demonstrated a compelling effect in several animal studies as a prophylactic and – more importantly – a therapeutic treatment against influenza and SARS-CoV-2.
Following a rigorous evaluation process, CEO of Pharma Holdings, Christian Lütken, is excited that the compound has been accepted as a candidate for the ECRAID-Prime trial.
“This is a tremendous recognition of our lead candidate as a promising treatment for viral respiratory infections. Our ultimate goal is to make a meaningful impact on patients’ health, and we are hopeful that the trial will replicate the promising results seen in pre-clinical studies, helping to prevent health complications from respiratory infections and promote a faster recovery in outpatients."
– Christian Lütken, CEO of Pharma Holdings
In addition, Christian and his team found the trial preparation process highly valuable. He added, “The opportunity to meet, interact with the highly competent teams at University Medical Center Utrecht, University of Oxford and Ecraid, has been invaluable. We are looking forward to being part of a platform trial, which combines the benefits of an approved master protocol with a robust and fully operational infrastructure. The presence of numerous trained primary care sites across several countries offers significant advantages in terms of speed, quality and execution of the study.”
The Phase 2A study is set to begin recruitment in Q4 2025 in Belgium, Ireland, Poland, Spain, and Georgia.
Strengthening Primary Care Research & Response
The EU-funded ECRAID-Prime trial is an ambitious effort to establish clinical trials in primary care across Europe. Compared to traditional randomised controlled trials, this innovative adaptive platform trial design offers flexibility by enabling the addition, evaluation, or discontinuation of treatments based on interim results of emerging data. This faster and more efficient approach allows governments, researchers and healthcare providers to respond in real-time to emerging data and adjust their protocols accordingly during health crises, when time and responsiveness are critical.
“ECRAID-Prime is the largest multi-country, adaptive platform trial that focusses on managing infections in the community. It is not only mission-critical for evaluating new treatments for current epidemic infections, but also a key component of Europe’s pandemic preparedness.
The introduction of LTX-109 to ECRAID-Prime underscores the value of the platform approach, which enables us to efficiently test multiple treatments simultaneously, and incorporate new treatments under the same master protocol, even after the trial has begun. This innovative design enhances efficiency, shortens time-to-result, and represents a huge leap forward compared to having to set up a separate trial for every promising new treatment!"
– ECRAID-Prime Co-Coordinator, Chris Butler, University of Oxford
ECRAID-Prime is funded by the European Union’s HORIZON 2021 – 2027 Research and Innovation Programme, under Grant Agreement number 101046109
Read more about the study and its research in primary care.