R-3750 / Rise Therap - LARVOL DELTA

Clinical Evaluation of R-3750: A Novel Synthetic Biology-Derived Immunotherapy for Ulcerative Colitis (ACG 2025) - "R-3750 was safe and well tolerated, with no drug-related adverse events. qPCR showed no systemic SlpA, confirming gut-restricted activity. Clinically, treatment with R-3750 led to meaningful and sustained improvements in disease activity and quality of life."

Clinical • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease • Ulcerative Colitis

R-3750-01-LU: A Repeat Ascending Dosing Study of the Safety and Clinical Activity of R-3750 in Patients With Mild to Moderate COPD (clinicaltrials.gov) - P1 | N=27 | Not yet recruiting | Sponsor: Rise Therapeutics LLC

New P1 trial • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

Rise Therapeutics Reports Ulcerative Colitis Dose Escalation Clinical Results for R-3750 at the Digestive Disease Week (DDW) Conference in San Diego May 3-6 (PRNewswire) - "Rise Therapeutics...today announced that it will report its first clinical results from the completed dose escalation segment of its R-3750 Phase 1 clinical trial in ulcerative colitis at the upcoming DDW conference in San Diego on May 6th....The safety and tolerability, drug exposure, and clinical activity of R-3750 in patients with mild to moderate ulcerative colitis will be presented by Dr. Christian Furlan Freguia, SVP R&D on May 6th, at 10:30 AM (PT)"

P1 data • Ulcerative Colitis

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-3750 in Patients With Mild to Moderate Ulcerative Colitis (clinicaltrials.gov) - P1 | N=36 | Recruiting | Sponsor: Rise Therapeutics LLC | Trial completion date: Feb 2025 ➔ Oct 2025 | Trial primary completion date: Oct 2024 ➔ Sep 2025

Trial completion date • Trial primary completion date • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

New Funding Secured to Support Clinical GMP Manufacturing Expansion Expansion at Rise Therapeutics (Rise Therapeutics Press Release) - "Rise Therapeutics announced today that it has received funding from the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at the National Institute of Health (NIH) to enable infrastructure improvement that will scale GMP production and accelerate quality assurance (QA) and quality control (QC), significantly enhancing its biologics drug manufacturing capabilities. This Commercial Readiness Pilot (CRP) Program SBIR award will also support Phase 2 clinical GMP manufacturing to advance Rise Therapeutics’ R-3750 program currently completing a Phase 1 proof-of-concept clinical trial in patients suffering from ulcerative colitis."

Financing • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Development of Novel Immunological-Directed Synthetic Biology-Based Microbiome Therapeutics (ASGCT 2024) - P1 | "This study consists of a dose escalation stage, in which three doses of R-3750 are tested; and an expansion stage, where additional patients are enrolled at the highest tolerated dose. The study is currently enrolling.Overall, non-viral engineered probiotic-based therapies, like R-3750, represent a new strategy to tackle hard-to-treat diseases by allowing to treat patients sooner, improve compliance, and, for a drug like R-3750 which remains localized to the oral-gut cavity and is not systemically delivered, minimizes potential adverse reactions."

Gastroenterology • Gastrointestinal Disorder • Hematological Disorders • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis • CD4 • FOXP3 • IL10 • IL17A • IL1B • IL6 • TNFA

R-3750 in Patients With Mild to Moderate Ulcerative Colitis (clinicaltrials.gov) - P1 | N=36 | Recruiting | Sponsor: Rise Therapeutics LLC | Not yet recruiting ➔ Recruiting

Enrollment open • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Rise Therapeutics Announces FDA Clearance of its IND Application to Initiate a Phase 1 Study of an Oral Immunotherapy for the Treatment of Ulcerative Colitis (PRNewswire) - "Rise Therapeutics...announced that the U.S. Food and Drug Administration (FDA) has accepted its investigational new drug (IND) application to proceed with a Phase 1 clinical trial of its lead program candidate, R-3750."

IND • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

R-3750 in Patients With Mild to Moderate Ulcerative Colitis (clinicaltrials.gov) - P1 | N=36 | Not yet recruiting | Sponsor: Rise Therapeutics LLC

New P1 trial • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis