The US Food and Drug Administration (FDA) has accepted Rise Therapeutics’ investigational new drug (IND) application enabling initiation of a Phase I clinical trial of R-2487 to treat rheumatoid arthritis.

The single and repeat dose study will evaluate the drug exposure, tolerability, safety, and clinical activity of the cellular immunotherapy R-2487.

It intends to enrol nearly 36 subjects and the clinical activity of R-2487 will be assessed by measuring improvement in rheumatoid arthritis disease severity, and various key biomarker and pharmacodynamic assessments.

Rise Therapeutics president and CEO Gary Fanger said: “We are extremely excited to initiate our second clinical-stage programme at Rise Therapeutics with the evolution of R-2487.

“As we grow our clinical development infrastructure, our plan is to clinically validate a series of life-saving medications based upon our synthetic biology platform technology to evolve oral immunotherapy approaches that both improve the ease of delivery of protein-based biologics therapy and reduce the cost of these important immune regulatory-based medicines.

“We believe R-2487 has the potential to broadly treat autoimmune diseases.”

R-2487 is the company’s second clinical programme developed utilising synthetic biology and oral biologics delivery platform. It induces regulatory T cells and resets immune balance in patients with autoimmunity.

Rise Therapeutics claims that R-2487 has the potential to target the root cause of the disease and reverse its development.

The company is also engaged in developing new immune modulatory drugs for the treatment of cancer, infection, and inflammation.