US-based biotechnology company Rise Therapeutics has enrolled the first subject in its Phase I clinical trial of R-2487, a new oral immunotherapeutic medicine intended to treat rheumatoid arthritis.
The first-in-human study will evaluate R-2487's pharmacodynamics, safety and clinical activity in rheumatoid arthritis patients across various US sites.
It will enrol up to 36 subjects and aims to establish the drug's clinical activity by assessing disease severity improvements and using various key biomarker and pharmacodynamic evaluations.
R-2487 is a synthetic biology-based immunotherapy that functions by eliciting bystander tolerance through the evolution of T regulatory (Treg) cells.
Its mechanism of action aims to rearrange Treg deficiencies to cut down inflammatory cytokines linked to autoimmune ailments.
Rise Therapeutics president and CEO Gary Fanger said: “This is an important milestone for the company and patients suffering from rheumatoid arthritis.
“This achievement reinforces our commitment to deliver innovative new medicines to the clinical community.”
Rheumatoid arthritis is an inflammatory disorder that impacts a significant portion of the world's population, with prevalence rates varying by geographical location and gender.
The disease primarily impacts the synovial joints and can lead to disability in around half of all affected patients over time.
Based in Rockville, Maryland, Rise Therapeutics is a privately held biotechnology company that focuses on developing immunological-based biological medicines.
The company has developed R-2487 using its oral biologics drug delivery platform, which combines a ‘one drug, one target’ approach with a robust understanding of immune mechanisms.
Last October, the US Food and Drug Administration (FDA) accepted an investigational new drug (IND) application from Rise Therapeutics, allowing the trial to begin.
Last year, the company received FDA clearance for an IND application to begin a Phase I trial of its lead programme candidate, R-3750, which is intended to treat inflammatory bowel disease.
