SynAct Pharma has announced a refined strategic focus for the continued development of its lead compound, resomelagon (AP1189). The company will pursue two parallel development tracks: early intervention in autoimmune and inflammatory diseases, with primary focus on rheumatoid arthritis (RA), and development of resomelagon as host-directed therapy in viral infections.
The aim in both development tracks is to restore immune balance and induce the immune system’s ability to resolve the inflammation.
Strategy update: new indication added
SynAct’s development strategy includes completing patient recruitment for the ADVANCE phase IIb study in newly diagnosed rheumatoid arthritis (RA) by 2025 and initiating a phase IIa proof-of-concept study in polymyalgia rheumatica (PMR).
PMR is an inflammatory condition marked by severe bilateral pain and morning stiffness in the shoulders, neck, and pelvic girdle. It primarily affects middle-aged and older adults and is the second most common rheumatic disease after RA in Northern Europe and North America.
To explore the potential of resomelagon in PMR, SynAct plans to collaborate with leading Nordic rheumatologists and will file a clinical trial application for a phase II study. The aim is to evaluate resomelagon’s ability to reduce the use of glucocorticoids in PMR treatment.
Expanded pipeline sets stage for future partnerships
According to the company, adding another indication to the pipeline could enhance business development opportunities and increase the overall deal value potential.
– The refined development strategy for resomelagon optimises the opportunity for commercial partnerships. Since the autumn we have succeeded on executing the ADVANCE phase 2b study with recruitment according to plan and setup and initiate the RESOVIR-2 study in dengue, says CEO Jeppe Øvlesen.
Within the viral infection track, the company will proceed with the RESOVIR-2 study in dengue and continue preclinical evaluation of resomelagon in viral indications to support a future phase II clinical study in patients with respiratory insufficiency caused by viral infections.
In parallel, SynAct will also continue patient recruitment in the ongoing study in idiopathic membranous nephropathy.
SynAct Pharma secures financing to accelerate the plan
To support the execution of its renewed strategy, SynAct Pharma has secured a financing solution combining a SEK 37 million directed share issue and a SEK 30 million credit facility.
The directed issue was subscribed by a group of long-term and strategically aligned investors, including Hunter Capital, Sanos Group, Johannes Schildt, and Thomas Ringberg. The credit facility is provided by Hunter Capital and can be utilised in full or in parts up until December 31, 2026.
The financing strengthens SynAct’s financial position, extending its runway through the end of 2026. It enables the company to maintain momentum across both development tracks while actively advancing partnership discussions.
Capital Markets Day
To share recent progress and strategic updates, SynAct Pharma hosted a Capital Markets Day (CMD) at Sergelkonferensen in central Stockholm, bringing together investors, analysts, and media representatives.
Chairman Anders Kronborg opened the event with a welcome note, followed by CEO Jeppe Øvlesen who presented a corporate update outlining the refined development strategy, upcoming milestones, business development activities, and financial position.
Chief Scientific Officer Thomas Jonassen discussed resomelagon’s ability to promote resolution of inflammation and its therapeutic potential in both inflammatory and autoimmune diseases and viral infections. He also shared key insights from previous studies in RA and highlighted the opportunities in polymyalgia rheumatica.
Professor Mauro Teixeira provided an expert perspective on resomelagon’s role in treating viral infections, with a particular focus on the ongoing RESOVIR-2 trial in dengue fever.
Chief Operating Officer Thomas Boesen presented the company’s strengthened patent portfolio for resomelagon and provided an overview of the TXP development program.
CEO highlights study progress and the support from investors
The event concluded with a summary and outlook by CEO Jeppe Øvlesen, who emphasised that the ADVANCE study remains on track, with data expected by the end of the year. He noted that the goal is to use these results as a foundation for securing a partnership. Øvlesen also highlighted the launch of the PMR study, describing it as a strong complement to the RA program and well aligned with the interests of potential partners.
Øvlesen concluded by thanking the investors whose support made it possible to raise additional capital, securing full funding through the end of 2026. He also noted that the company continues to broaden its investor base, now comprising more than 15,000 shareholders.
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