The SynAct-CS009-RESPIRE study has been approved and the first visit of a study participant is expected in Q1 2026. Thus, SynAct Pharma is executing on its dual strategy for resomelagon by progressing the development in host-directed therapy in viral infections alongside development in its lead indication in RA and other autoimmune diseases.

“With the respiratory viral season hitting Europe it’s critical to test resomelagon as a safe and effective therapy to avoid the potential devastating consequences of respiratory insufficiency leading to hospitalizations of millions of people in Europe and the U.S. annually,” said Thomas Jonassen, Chief Scientific Officer of SynAct Pharma. “The Phase 2 RESPIRE trial builds on convincing results in Covid-19 patients1 showing faster recovery with fewer days in hospital and intensive care needs, and results from influenza models2 showing that resomelagon had significant treatment effects including prevention of mortality. In this new study, we want to demonstrate a reduction in events leading to intensive unit care and prolonged hospitalization.”

The study is a randomized, double-blind, multicenter, placebo-controlled study enrolling 96 patients. The study population will consist of hospitalized participants with respiratory insufficiency expected to be caused by respiratory viral infection.

“This opportunity is a significant expansion of the potential use of resomelagon in the hospital setting”, said Mads Bjerregaard, Chief Business Officer of SynAct Pharma. “By executing on our dual development strategy, we are also expanding on our discussions with partners driving innovation in the hospital business.”