Rise Therapeutics has announced FDA clearance of its Investigational New Drug (IND) application for R-2487, a novel oral immunotherapy, paving the way for a Phase 1 clinical trial in patients with rheumatoid arthritis. This marks the company's second clinical program utilizing its synthetic biology platform and proprietary oral biologics delivery system.
R-2487 is designed to modulate the immune system by inducing regulatory T cells (Tregs), which are crucial for maintaining immune homeostasis and preventing autoimmunity. The drug aims to redirect immune responses away from inflammatory pathways by educating dendritic cells. Rise Therapeutics believes R-2487 has the potential to target the underlying immunological basis of rheumatoid arthritis and reverse disease progression.
Clinical Trial Details
The Phase 1 trial will be a single and repeat dose study involving up to 36 participants with rheumatoid arthritis. Researchers will evaluate the safety, tolerability, and drug exposure of R-2487. Clinical activity will be assessed by monitoring improvements in rheumatoid arthritis disease severity and measuring key biomarker and pharmacodynamic changes.
Rise Therapeutics' Perspective
Gary Fanger, President and CEO of Rise Therapeutics, expressed enthusiasm for the initiation of the R-2487 program. "We are extremely excited to initiate our second clinical-stage program at Rise Therapeutics with the evolution of R-2487," he stated. Fanger also highlighted the company's plan to clinically validate a series of medications based on its synthetic biology platform, aiming to improve the delivery and reduce the cost of immune regulatory-based medicines.
Oral Biologics Delivery Platform
Rise Therapeutics focuses on developing immunological-based biological medicines using a unique oral biologics delivery platform. This platform allows for the oral administration of targeted protein therapies via capsules, offering a potentially more convenient and cost-effective alternative to traditional injectable or infused biologics.
Broader Implications
Beyond rheumatoid arthritis, Rise Therapeutics believes R-2487 has the potential to treat a range of autoimmune diseases. The company is also engaged in developing new immune modulatory drugs for the treatment of cancer, infection, and inflammation.
