ROCKVILLE, MD, June 2, 2026 /PRNewswire/ -- Rise Therapeutics, a clinical-stage biotechnology company advancing novel oral immunotherapies for autoimmune diseases, today announced the completion of full enrollment in the 4-week dose expansion cohort of its Phase 1b clinical trial (NCT05961592) evaluating orally dosed R-2487 in patients with active rheumatoid arthritis (RA). Confirmation of the drug free, durability of clinical response marks a key inflection point in the program's clinical development.

The multi-center U.S. clinical trial is evaluating R-2487 in patients with active RA in combination with standard of care, targeting intervention before patients begin treatment with biologics or JAK inhibitors. The expansion cohort enrolled 40 patients and reinforced key product positioning in the early-stage treatment segment for RA by enabling a more robust assessment of clinical activity, safety, pharmacodynamic mechanisms, and durability of response in a broader patient population. Completion of enrollment positions the company to advance R-2487 into Phase 2 clinical development.

"This milestone represents a significant step forward in unlocking the value of the R-2487 program," said Gary Fanger, PhD, President and Chief Executive Officer of Rise Therapeutics. "Completion of the 4-week dosing expansion cohort reflects the strong execution of our clinical development strategy and further supports the potential of our platform to address a meaningful unmet need in autoimmune disease. We believe R-2487's differentiated mechanism of action, convenient oral delivery, favorable safety profile and durable drug-free clinical responses positions R-2487 as a promising therapeutic candidate within a large and evolving RA landscape."

The Company's independent Data Monitoring Committee (DMC) recently completed a scheduled review of available safety and clinical data from the study and recommended progression of clinical development. This recommendation marks an important advancement for the R-2487 clinical program and enables continued evaluation of the therapy over an extended treatment period. Data from the 4-week dose expansion cohort will be presented at upcoming national and international rheumatology and immunology conferences, as appropriate and as analyses become available.

Dr. Fanger added: "In parallel with the ongoing clinical expansion cohorts evaluating extended dosing and enrolling patients with overlapping RA and Sjögren's disease, we are preparing R-2487 for the next stage of clinical development. This includes advancing clinical protocol design, dose selection strategy, and regulatory engagement to support a Phase 2 clinical evaluation. We are also scaling key operational capabilities, including GMP manufacturing, to enable an efficient transition into the next phase of development for this program."

RA is a multi-billion-dollar global market with continued demand for therapies that combine early intervention, improved tolerability, and disease-modifying potential. Despite the widespread use of biologics and JAK inhibitors, a substantial proportion of patients experience suboptimal responses or treatment-related limitations, highlighting the opportunity for the novel R-2487 treatment approach.

About R-2487

R-2487 is a synthetic biology-based immunotherapy designed to address underlying immune dysfunction in autoimmune diseases. The therapy works by inducing bystander immune tolerance through modulation of regulatory T cells (Tregs), targeting a core driver of chronic inflammation.

This approach represents a novel, disease-modifying mechanism with the potential to reset the immune system, restoring immune balance rather than immune suppression. R-2487 is enabled by Rise Therapeutics' proprietary oral biologics delivery platform, which offers advantages in patient convenience, compliance, and earlier-line use compared to injectable biologics.

About Rise Therapeutics

Rise Therapeutics is a privately held biotechnology company based in Rockville, Maryland, focused on developing innovative immunological therapies using synthetic biology. The company's platform integrates targeted immune modulation with oral biologic delivery to create differentiated therapeutic candidates. With internal GMP manufacturing capabilities and a growing clinical pipeline, Rise Therapeutics is positioned to advance multiple programs targeting autoimmune and inflammatory diseases while pursuing value-creating partnerships and strategic growth opportunities, including the continued advancement of R-2487 into Phase 2 clinical development. For more information, visit www.risetherapeutics.com.

Contact: hr@risetherapeutics.com

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SOURCE Rise Therapeutics