SynAct Pharma Launches Phase II Trial of Resomelagon for Dengue Treatment in Brazil

SynAct Pharma (搜索)搜索该词条 has launched an investigator-initiated Phase II clinical trial evaluating its lead candidate resomelagon查看药品详情 (AP1189查看药品详情) in patients with dengue (搜索)搜索该疾病 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 (搜索)搜索该疾病, who will receive either once-daily oral resomelagon查看药品详情 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 (搜索)搜索该疾病 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查看药品详情 has shown to reduce severity of Dengue (搜索)搜索该疾病 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 (搜索)搜索该词条. "These new data together with the significant positive clinical outcome of resomelagon in the RESOVIR-1 study in hospitalized COVID-19 (搜索)搜索该疾病 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查看药品详情 in the RESOVIR-1 study, which demonstrated clinical proof-of-concept in COVID-19 (搜索)搜索该疾病 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查看公司主页 (UFMG) in Belo Horizonte, Brazil. Recruitment and completion timelines will depend on the severity of this year's dengue (搜索)搜索该疾病 epidemic at the clinical sites.

Dual Development Strategy

This investigator-initiated trial runs parallel to SynAct's ongoing development of resomelagon查看药品详情 for rheumatoid arthritis (搜索)搜索该疾病, 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查看药品详情 belongs to SynAct Pharma (搜索)搜索该词条's portfolio of selective melanocortin agonists designed to resolve inflammation through targeted activation of the melanocortin system (搜索)搜索该靶点. 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 (搜索)搜索该疾病 represents an important opportunity to address a significant unmet medical need, as current treatment options are limited to supportive care. If successful, resomelagon查看药品详情 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.