R-2487 / Rise Therap - LARVOL DELTA

R-2487, a Synthetic Biology-Based Oral Immunotherapy, Promotes Treg-Mediated Immune Rebalancing and Reduces Disease Activity in Rheumatoid Arthritis Patients (ACR Convergence 2025) - "Oral administration of R-2487 was safe, well tolerated, and induced meaningful improvements in RA disease activity. The observed peripheral Treg expansion suggests that R-2487 rebalances immune homeostasis through a tolerogenic DC–Treg pathway, illustrating the novel mechanism of action of R-2487. These findings validate the utility of a synthetic biology approach to immune modulation in autoimmune disease, highlight the potential of leveraging microbiome-associated immune control mechanisms, and support continued development of R-2487 in RA."

Clinical • Immune Modulation • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology

Rise Therapeutics Secures New Funding to Advance First-in-Class R-2487 Oral Immune Biomodulator into Sjogren's Disease Clinical Testing (PRNewswire)

Financing • Sjogren's Syndrome

R-2487-RA01: R-2487 in Patients With Rheumatoid Arthritis (clinicaltrials.gov) - P1 | N=73 | Recruiting | Sponsor: Rise Therapeutics LLC | N=36 ➔ 73 | Trial completion date: Jan 2026 ➔ Dec 2026 | Trial primary completion date: Nov 2025 ➔ Nov 2026

Enrollment change • Trial completion date • Trial primary completion date • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology

R-2487-SS-01: R-2487 in Patients With Sjogren's Syndrome (SS) (clinicaltrials.gov) - P1 | N=36 | Not yet recruiting | Sponsor: Rise Therapeutics LLC | Trial completion date: Aug 2027 ➔ Aug 2028 | Trial primary completion date: Aug 2027 ➔ Aug 2028

Trial completion date • Trial primary completion date • Immunology • Sjogren's Syndrome

Dose Escalation Completed for Rise Therapeutics' R-3750 and R-2487 Clinical Trials (PRNewswire) - "Rise Therapeutics...announced that it has completed dose escalation enrollment stages for both its R-2487 and R-3750 clinical trials. Both studies will now initiate the planned dose expansion stages to enroll additional patients at fixed doses....R-2487 is being tested in a clinical trial designed to understand safety, pharmacodynamics, and clinical activity in patients suffering from rheumatoid arthritis (NCT05961592). R-3750 is being tested in a clinical trial designed to understand safety, pharmacodynamics, and clinical activity in patients suffering from ulcerative colitis (NCT05666960)."

Trial status • Rheumatoid Arthritis • Ulcerative Colitis

R-2487-SS-01: R-2487 in Patients With Sjogren's Syndrome (SS) (clinicaltrials.gov) - P1 | N=36 | Not yet recruiting | Sponsor: Rise Therapeutics LLC | Trial completion date: Aug 2026 ➔ Aug 2027 | Initiation date: Jun 2024 ➔ Jun 2025 | Trial primary completion date: Aug 2026 ➔ Aug 2027

Trial completion date • Trial initiation date • Trial primary completion date • Immunology • Sjogren's Syndrome

R-2487-SS-01: R-2487 in Patients With Sjogren's Syndrome (SS) (clinicaltrials.gov) - P1 | N=36 | Not yet recruiting | Sponsor: Rise Therapeutics LLC

New P1 trial • Immunology • Sjogren's Syndrome

First Patient Enrolled in Rise Therapeutics' Rheumatoid Arthritis Clinical Trial (PRNewswire) - "Rise Therapeutics...today announced that it has enrolled its first patient in its R-2487 Phase 1 rheumatoid arthritis clinical trial....The study will enroll up to 36 participants where clinical activity will be evaluated by improvement in disease severity and using a variety of key biomarker and pharmacodynamic assessments."

Trial status • Immunology • Rheumatoid Arthritis

R-2487-RA01: R-2487 in Patients With Rheumatoid Arthritis (clinicaltrials.gov) - P1 | N=36 | Recruiting | Sponsor: Rise Therapeutics LLC | Not yet recruiting ➔ Recruiting

Enrollment open • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology • CRP

FDA Clears Rise Therapeutics' IND Application to Initiate a Phase 1 Clinical Study of Its Novel Oral Immunotherapy for the Treatment of Rheumatoid Arthritis (PRNewswire) - "Rise Therapeutics...today announced that the U.S. Food and Drug Administration (FDA) has accepted its investigational new drug (IND) application to proceed with a rheumatoid arthritis Phase 1 clinical trial for its program candidate, R-2487....The Phase I clinical trial will be a single and repeat dose study assessing the safety and tolerability, drug exposure, and clinical activity of R-2487 in patients with rheumatoid arthritis."

IND • New P1 trial • Immunology • Rheumatoid Arthritis

R-2487-RA01: R-2487 in Patients With Rheumatoid Arthritis (clinicaltrials.gov) - P1 | N=36 | Not yet recruiting | Sponsor: Rise Therapeutics LLC

New P1 trial • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology • CRP