SynAct Pharma
SynAct Pharma is a clinical stage biotechnology company focused on developing innovative treatments that resolve inflammation in acute and chronic diseases. Their lead compound, Resomelagon (AP1189), is an oral therapy that activates melanocortin receptors to restore immune balance. The company aims to reduce disease progression through early intervention and explore modulation of hyperinflammatory stages in viral diseases, potentially establishing a new standard of care. Their approach centers on resolving inflammation without suppressing the immune system, addressing unmet medical needs with patient-friendly, safe, once-daily oral treatments. SynAct's development programs include Phase 2b trials for rheumatoid arthritis and ongoing Phase 2 studies for viral infections like Dengue fever.
Industries
Nr. of Employees
small (1-50)
SynAct Pharma
Products
Clinical-stage oral selective melanocortin receptor agonist (once-daily tablet)
Oral, once-daily small-molecule agonist designed to selectively activate melanocortin receptors to promote resolution of inflammation; developed for inflammatory and autoimmune indications and evaluated in Phase II clinical studies.
Preclinical injectable peptide melanocortin receptor agonist (IV infusion candidate)
Peptide agonist candidate in preclinical development intended for intravenous infusion to preserve organ function in high-risk hospitalized patients; planned readiness for first-in-human clinical development.
Clinical-stage oral selective melanocortin receptor agonist (once-daily tablet)
Oral, once-daily small-molecule agonist designed to selectively activate melanocortin receptors to promote resolution of inflammation; developed for inflammatory and autoimmune indications and evaluated in Phase II clinical studies.
Preclinical injectable peptide melanocortin receptor agonist (IV infusion candidate)
Peptide agonist candidate in preclinical development intended for intravenous infusion to preserve organ function in high-risk hospitalized patients; planned readiness for first-in-human clinical development.
Services
Early-phase clinical development for small molecules and peptides
End-to-end clinical program execution for early-phase studies including protocol implementation, patient recruitment, dosing and topline reporting.
Formulation and CMC development for oral and injectable forms
Development and optimization of oral and injectable formulations and coordination of CMC activities with external partners to support clinical programs.
Preclinical safety and toxicology programs
Design and coordination of toxicology and safety pharmacology studies in multiple species to generate safety data supporting clinical dosing durations.
Regulatory filing and submission support
Preparation and submission of regulatory dossiers and management of authority interactions to enable clinical trials.
Academic and translational research collaborations
Partnerships with academic laboratories to study mechanism of action and develop translational pharmacology evidence for program candidates.
Corporate development and portfolio integration
Acquisition and integration of external compound portfolios and management of investor and capital market activities to support pipeline growth.
Early-phase clinical development for small molecules and peptides
End-to-end clinical program execution for early-phase studies including protocol implementation, patient recruitment, dosing and topline reporting.
Formulation and CMC development for oral and injectable forms
Development and optimization of oral and injectable formulations and coordination of CMC activities with external partners to support clinical programs.
Preclinical safety and toxicology programs
Design and coordination of toxicology and safety pharmacology studies in multiple species to generate safety data supporting clinical dosing durations.
Regulatory filing and submission support
Preparation and submission of regulatory dossiers and management of authority interactions to enable clinical trials.
Academic and translational research collaborations
Partnerships with academic laboratories to study mechanism of action and develop translational pharmacology evidence for program candidates.
Corporate development and portfolio integration
Acquisition and integration of external compound portfolios and management of investor and capital market activities to support pipeline growth.
Expertise Areas
- Clinical trial management (Phase I–IIb)
- Early-stage drug development
- Formulation and CMC for oral and injectable therapeutics
- Preclinical toxicology and safety pharmacology
Key Technologies
- Melanocortin receptor-targeted agonists
- Oral small-molecule formulation (tablet and suspension)
- Injectable peptide formulation and IV infusion preparation
- Clinical pharmacokinetic (PK) analysis