SynAct Pharma has launched an investigator-initiated Phase II clinical trial evaluating its lead candidate resomelagon (AP1189) in patients with dengue fever in Brazil. The RESOVIR-2 study will test the melanocortin agonist as a potential first-in-class treatment for the mosquito-borne viral infection, which currently has no specific pharmacological therapy available.
The randomized, placebo-controlled trial will enroll 120 patients with symptomatic dengue, who will receive either once-daily oral resomelagon or placebo (1:1 randomization) as an add-on to standard care. The study's primary endpoint will measure time to disease resolution through a composite clinical endpoint, while secondary endpoints will assess the drug's ability to reduce warning signs and prevent progression to severe dengue.
Addressing an Expanding Global Health Threat
Dengue fever, transmitted primarily through Aedes mosquitoes, has traditionally been confined to tropical and subtropical regions but has recently expanded into Europe and the United States, likely due to climate change. The disease typically causes high fever, headache, body aches, nausea, and rash, but can progress to a critical phase characterized by bleeding, organ dysfunction, and hemodynamic shock in some patients.
"Resomelagon has shown to reduce severity of Dengue in experimental animal models and to reduce the proinflammatory activity of human white cells challenged with Dengue Virus," said Thomas Jonassen, CSO at SynAct Pharma. "These new data together with the significant positive clinical outcome of resomelagon in the RESOVIR-1 study in hospitalized COVID-19 patients support the rationale for resomelagon as a novel treatment approach for host-directed therapy in viral infections."
Building on Previous Success in Viral Infections
The RESOVIR-2 trial builds on SynAct's previous success with resomelagon in the RESOVIR-1 study, which demonstrated clinical proof-of-concept in COVID-19 patients. This new study could further validate the drug's potential as a host-directed therapy for resolving inflammation in severe viral infections.
The trial is being led by Professor Mauro Teixeira, MD, PhD, from Universidade Federal de Minas Gerais (UFMG) in Belo Horizonte, Brazil. Recruitment and completion timelines will depend on the severity of this year's dengue epidemic at the clinical sites.
Dual Development Strategy
This investigator-initiated trial runs parallel to SynAct's ongoing development of resomelagon for rheumatoid arthritis, highlighting the company's strategy to explore multiple indications for its selective melanocortin agonist platform.
"We work behind the scenes to expand our pipeline and look forward to presenting the next program(s) once we are ready," Jonassen noted, suggesting additional indications may be in development.
Mechanism of Action
Resomelagon belongs to SynAct Pharma's portfolio of selective melanocortin agonists designed to resolve inflammation through targeted activation of the melanocortin system. This approach aims to induce anti-inflammatory activity in autoimmune and inflammatory diseases, helping patients achieve immune balance and overcome inflammation.
The drug's potential in dengue represents an important opportunity to address a significant unmet medical need, as current treatment options are limited to supportive care. If successful, resomelagon could become the first specific treatment for dengue, a disease that affects millions of people worldwide annually.
Information about the RESOVIR-2 study has been uploaded to the clinical trials registry and will be available at www.clinicaltrials.gov.
