Rise Therapeutics LLC

ROCKVILLE, Md., July 15, 2024 /PRNewswire/ -- Rise Therapeutics, a clinical-stage biotechnology company developing novel oral immunotherapeutic medicines, today announced that it has enrolled its first patient in its R-5280 placebo controlled, blinded, Phase 1b type 1 diabetes clinical trial. Gary Fanger President and Chief Executive Officer of Rise Therapeutics stated, "With our third drug now in clinical development, we have the opportunity with R-5280 to control another devastating disease using an oral immunotherapy approach." Type 1 diabetes is a chronic autoimmune condition where the pancreas produces little to no insulin. Without enough insulin, blood sugar levels can become dangerously high. Type 1 diabetes typically develops in childhood or adolescence and patients require lifelong insulin therapy to manage their blood sugar levels and prevent complications. Approximately 1.6 million people in the United States are affected by type 1 diabetes, and around 40,000 people receive a new diagnosis of type 1 diabetes in the U.S each year. The Phase 1b clinical trial (NCT06057454) is a placebo controlled, blinded clinical trial designed to determine the clinical activity and safety of R-5280 in new onset type 1 diabetes patients. The clinical study is being conducted at multiple sites in the United States. This repeat dose study in patients is meant to determine if R-5280 can block the advancement of beta islet cell destruction. The study will enroll 39 participants where clinical activity will be evaluated by improvement in disease severity and using a variety of key biomarkers. About R-5280 R-5280 is an oral immunotherapy focused on controlling immune pathways that lead to autoimmune disease. This product candidate has been selectively designed to engage the immune system to control inflammation by influencing immune cell differentiation and inflammatory cytokine production that contribute to autoimmunity. R-5280 has demonstrated improvement of type 1 diabetes symptoms in a previous pilot clinical study. About Rise Therapeutics Rise Therapeutics is an emerging, privately held biotechnology company located in Rockville, Maryland, which leverages its expertise in synthetic biology and immunological drug development to create novel cellular-based immune therapies. With a strong emphasis on product development and its internal clinical GMP manufacturing infrastructure, Rise is focused on developing immunological-based biological medicines using a unique and proprietary oral biologics delivery platform. For more information, go to . Contact: Media Relations Email: [email protected] SOURCE Rise Therapeutics

ROCKVILLE, Md., Jan. 29, 2024 /PRNewswire/ -- Rise Therapeutics, a clinical-stage biotechnology company developing novel oral immunotherapeutic medicines, today announced that it has enrolled its first patient in its R-2487 Phase 1 rheumatoid arthritis clinical trial. "This is an important milestone for the company and patients suffering from rheumatoid arthritis" states Gary Fanger President and Chief Executive Officer of Rise Therapeutics. "This achievement reinforces our commitment to deliver innovative new medicines to the clinical community." Rheumatoid arthritis is a chronic, systemic inflammatory disorder affecting up to 0.24% of the world population, and as much as 1% of the US population. The exact frequencies depend on geographical origin and gender with women being three times more affected than men. Rheumatoid arthritis attacks the synovial joints of patients, where approximately half of the affected patients become disabled over the progression of the disease. The Phase I rheumatoid arthritis clinical trial (NCT05961592) is a first-in-human clinical trial designed to understand safety, pharmacodynamics, and clinical activity of R-2487 in patients suffering from rheumatoid arthritis. The clinical study is being conducted in the United States at multiple sites around the country. This single and repeat dose study in patients is positioning R-2487 to intervene in rheumatoid arthritis progression prior to traditional infused biologics therapy. 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. About R-2487 R-2487 is a synthetic biology-based immunotherapy being developed to treat autoimmune disease. R-2487 works by inducing bystander tolerance via evolution of specific immune cells called T regulatory (Treg) cells. R-2487 has a novel mechanism of action, resetting Treg deficiencies to reduce inflammatory cytokines that contribute to autoimmune disease. R-2487 leverages Rise Therapeutics' proprietary oral biologics drug delivery platform focusing on 'one drug, one target' combined with solid understanding of immune mechanism of action to evolve more efficient and faster clinical trial endpoints. About Rise Therapeutics Rise Therapeutics is an emerging, privately held biotechnology company located in Rockville, Maryland, which leverages its expertise in synthetic biology and immunological drug development to create novel cellular-based immune therapies. With a strong emphasis on product development and its internal clinical GMP manufacturing infrastructure, Rise is focused on developing immunological-based biological medicines using a unique and proprietary oral biologics delivery platform. For more information, go to . Media Relations Email: hr@risetherapeutics.com

ROCKVILLE, Md., Oct. 19, 2023 /PRNewswire/ -- Rise Therapeutics, a biotechnology company engaged in developing novel oral immunotherapeutics, 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. This is Rise Therapeutics' second clinical program developed using synthetic biology and its proprietary oral biologics delivery platform. Designed specifically to induce regulatory T cells (Tregs) and reset immune balance in patients suffering from autoimmunity, R-2487 works by educating dendritic cells to redirect immune responses away from inflammatory effects. R-2487 is a cellular immunotherapy being developed for the treatment of rheumatoid arthritis, engineered to treat the underlying immunological basis of autoimmune disease. Consequently, R-2487 has the potential to target the root cause of rheumatoid arthritis and reverse the development of this devastating disease. "We are extremely excited to initiate our second clinical-stage program at Rise Therapeutics with the evolution of R-2487" states Gary Fanger, President and CEO of Rise Therapeutics. "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." 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. The study will enroll up to 36 participants where the clinical activity of R-2487 will be evaluated by improvement in rheumatoid arthritis disease severity, and by measuring a variety of key biomarker and pharmacodynamic assessments. About Rise Therapeutics Rise Therapeutics is an emerging, privately held biotechnology company located in Rockville, Maryland, which leverages its expertise in synthetic biology and immunological drug development to create novel cellular-based immune therapies. With a strong emphasis on product development and its internal clinical GMP manufacturing infrastructure, Rise is focused on developing immunological-based biological medicines using a unique and proprietary oral biologics delivery platform. For more information, go to . For further enquiries, please contact: Media Relations Email: hr@risetherapeutics.com SOURCE Rise Therapeutics