May 27, 2025
SynAct Pharma has a remarkable drug candidate with resomelagon (AP1189). The data gained so far point to a significant change to how we help the body resolve excessive or chronic inflammation, situations when inflammation can overwhelm the immune system’s ability to counter the inflammation that can lead to suffering, tissue damage and loss of function.
We have an ambitious plan to take resomelagon to the next level, and the team continued its hard work during the first quarter to keep us on track. Our main focus remains on ensuring our Phase 2b ADVANCE study in patients with newly diagnosed severe rheumatoid arthritis (RA) stays on track as it continues to enroll the 240 patients before the end of 2025. The goal of the ADVANCE study is to confirm the treatment potential of the compound, previously reported in the BEGIN study and in the subset of newly diagnosed patients with signs of systemic inflammation in the EXPAND study, and to identify optimal doses for Phase 3 development in patients with newly diagnosed RA.
As the ADVANCE study is running full speed, we wanted to follow through with our ambition to test resomelagon with other indications in need of new treatment options. After a lot of work during the first few months of the year, SynAct was able to announce in April the start of a Phase 2 study of resomelagon with Dengue, a viral infection that spreads from mosquitoes to people, typically in tropical climates. It is estimated that more than 100 million people around the world get infected with the virus every year. Dengue symptoms are high fever, headache, body aches, nausea, and rash. In a subset of patients, the disease can develop into a critical phase characterized by bleeding, organ dysfunction and hemodynamic shock. When symptoms are present, no current specific pharmacological treatment is available.
RESOVIR-2 is a randomized, placebo-controlled Phase 2 study testing once-daily oral dosing of resomelagon vs placebo as add-on to standard treatment in patients with symptomatic Dengue. The study is initiated and led by Professor Mauro Teixeira, MD, PhD, Universidade Federal de Minas Gerais (UFMG), Belo Horizonte, at clinical sites in Brazil. As mentioned before, recruitment to and completion of the study depends on the severity of this year’s Dengue epidemic at sites. Dengue is a great place for SynAct to start as the company considers which other viral infections could make sense for resomelagon in the future.
We don’t plan on stopping there. We are working behind the scenes to further grow our pipeline, and we look forward to announcing new programs when the time is right. We see tremendous potential in resomelagon. SynAct also continued to strengthen the board of directors with Jeppe Ragnar Andersen, CEO of Sanos Group A/S, a global multi-niche CRO with full-service clinical capabilities. He has extensive experience in managing clinical studies and will be a welcome addition to the team as we scale up our pipeline further. It is also worth mentioning our strengthened patent position with resomelagon in both Europe and the US. Having extended patent protection until 2042 is pivotal for ensuring resomelagon’s value for us and future potential partners.
While the team is working hard to expand our pipeline, we are, of course, continuously working to maintain good relationships with potential partners. We know what needs to be done to take SynAct to the next level, and we are very grateful for all the support we get from all our shareholders.
Thanks for showing interest in SynAct.
Jeppe Øvlesen | CEO and Board Member