Resomelagon
- Generic Name
- Resomelagon
SynAct Pharma Secures Extended US Patent Protection for Resomelagon Combination Therapy Until 2042
• SynAct Pharma has received USPTO Issue Notification for patent 12,303,489, covering the combination of resomelagon (AP1189) with methotrexate for rheumatoid arthritis treatment.
• The patent, which will be issued on May 20, 2025, includes a significant Patent Term Adjustment of 769 days, extending market exclusivity until June 15, 2042.
• This strategic intellectual property development strengthens SynAct's position in the rheumatoid arthritis treatment landscape, potentially enhancing the commercial value of resomelagon during its projected peak sales period.
SynAct Pharma Launches Phase II Trial of Resomelagon for Dengue Treatment in Brazil
• SynAct Pharma has initiated the RESOVIR-2 study, a randomized Phase II trial evaluating resomelagon (AP1189) in 120 patients with dengue in Brazil, with no specific treatments currently available for the disease.
• Resomelagon has demonstrated promising results in reducing dengue severity in animal models and decreasing proinflammatory activity in human white cells exposed to dengue virus, building on previous success in COVID-19 patients.
• The study will assess resomelagon's efficacy through time to disease resolution and ability to reduce warning signs of severe dengue, potentially establishing a novel host-directed therapy approach for viral infections.
SynAct Pharma's Resomelagon Receives EU Trial Approval for Phase 2b Rheumatoid Arthritis Study
• SynAct Pharma received EU approval for its Phase 2b ADVANCE study of resomelagon (AP1189) in newly diagnosed severe rheumatoid arthritis (RA) patients.
• The ADVANCE study will evaluate three doses of resomelagon versus placebo, in combination with methotrexate, as a first-line RA treatment.
• The trial aims to enroll 240 patients across 7 countries in Europe and the US, with completion targeted for Q4 2025.
• Resomelagon, a melanocortin receptor agonist, offers a potential resolution-based approach to RA treatment, avoiding the immunosuppression of current therapies.
Drug Development Updates
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