HLA-B27 indications
Composition and indications for treatment of HLA-B27 diseases. Priority date: March 31, 2017.
Pipeline
Pipeline & development
Based on a robust preclinical research foundation, Ailm Biologics is advancing toward regulatory milestones with a validated pathway forward.
Development
Milestones
Advancing from discovery through regulatory readiness toward clinical development.
1
CompletedBasic research & discovery
2
In progressPre-clinical development
3
UpcomingRegulatory CMC
4
UpcomingPilot & IND-enabling studies
5
UpcomingPre-IND / US FDA IND
Regulatory
Regulatory readiness
Scientific Advice for advancing to an IND/IMPD has been obtained from the European Medicines Agency (EMA), providing a validated and clear regulatory pathway forward with the US FDA.
Market
Market opportunity
We are targeting a biologically defined, underserved subgroup of IBD patients with systemic diseases — a high-need segment representing enteropathic arthritis and broader IBD with extra-intestinal manifestations.
IP portfolio
Intellectual property
Ailm Biologics maintains 100% ownership with full freedom-to-operate in both the United States and Europe across two strategic patent families.
Microflora modulation
Nucleic acid therapy for differential modulation of host microflora. Priority date: September 30, 2020.