SynAct Pharma has clarified its strategic focus for the continued development of the drug candidate resomelagon. The company will work on two parallel development tracks: early treatment of autoimmune and inflammatory diseases, with a primary focus on rheumatoid arthritis (RA), and host-directed treatment of viral infections. In both cases, the goal is to restore immune balance and promote the body's own ability to resolve inflammation.
Strategy update: new indication
The development strategy includes completing patient recruitment in the ongoing Phase IIb study ADVANCE in newly diagnosed RA, as well as initiating a Phase IIa proof-of-concept study in polymyalgia rheumatica.
PMR is an inflammatory disease characterized by severe bilateral pain and morning stiffness in the shoulders, neck, and pelvic region. The disease primarily affects middle-aged and older adults and is the second most common rheumatic disease after RA in Northern Europe and North America.
SynAct plans to collaborate with leading Nordic rheumatologists and submit a clinical trial application for a Phase II study to investigate whether resomelagon can reduce the need for glucocorticoids in the treatment of PMR.
Expanded pipeline strengthens position for potential partnerships
According to the company, a new indication in the pipeline can create new business opportunities and potentially increase the value of a deal.
– The refined development strategy for resomelagon optimizes the opportunities for commercial partnerships. Since last fall, we have managed to complete the phase 2 ADVANCE study and patient recruitment according to plan, as well as start the RESOVIR-2 study in dengue fever, says CEO Jeppe Ovlesen.
Within the viral infection track, the company is continuing with the RESOVIR-2 study in dengue fever and preclinical evaluation of resomelagon in viral indications in preparation for a future phase II study for patients with respiratory insufficiency caused by viral infections.
In parallel, patient recruitment is also underway in a study for idiopathic membranous nephropathy.
Secured financing to accelerate the strategy
To enable the implementation of the strategy, SynAct has secured a combined financing solution consisting of a directed new share issue of SEK 37 million and a credit facility of SEK 30 million.
The new issue was subscribed by a major shareholder, including Hunter Capital, Sanos Group, Johannes Schildt and Thomas RingbergThe credit facility is provided by Hunter Capital and can be used in whole or in part until December 31, 2026.
The financing strengthens the company's financial position and enables continued advancement in both development tracks while intensifying partnership discussions.
Capital Markets Day
On June 4, SynAct Pharma organized a capital markets day at the Sergel Conference in central Stockholm, where investors, analysts and media gathered to share the latest progress and strategic updates.
Chairperson Anders Kronborg opened the event, followed by CEO Jeppe Øvlesen who presented an update on the company and the refined strategy, upcoming milestones, business development and financial position.
The company's Chief Scientific Officer Thomas Jonassen discussed the potential of resomelagon to promote inflammation resolution and its therapeutic potential in both inflammatory and autoimmune diseases as well as viral infections. He also shared important insights from previous RA studies and potential in PMR.
Professor Mauro Teixeira gave his perspective on the role of resomelagon in the treatment of viral infections and the progress of the RESOVIR-2 study in dengue.
Chief Operating Officer Thomas Boesen presented the strengthened patent portfolio for resomelagon as well as an overview of the TXP development program.
CEO summarizes progress and support from investors
The Capital Markets Day was concluded by CEO Jeppe Øvlesen, who emphasized that the ADVANCE study is progressing according to plan, with data reporting expected by the end of the year. The goal is to use these results to secure a partnership. He also highlighted that the development of resomelagon within PMR complements the RA program and is in line with the interest of potential partners.
Øvlesen concluded by thanking the investors who made the capital raising possible and thereby secured financing until the end of 2026. He also noted that the company continues to broaden its investor base, which now includes over 15 shareholders.
