Rise Therapeutics LLC

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

ROCKVILLE, Md., Jan. 31, 2023 /PRNewswire/ -- Rise Therapeutics, a biopharmaceutical company engaged in developing novel oral synthetic biology medicines, today 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. R-3750 is an oral synthetic biology-based cellular immunotherapy being developed to treat Inflammatory Bowel Disease. R-3750 is a synthetic biology-based cellular immunotherapy being developed for the treatment of Inflammatory Bowel Disease (IBD). Optimized for intestinal delivery of a key microbiome-associated immune regulatory molecule, R-3750 is an oral therapy with the potential to treat the underlying immunological basis of gastrointestinal-associated inflammatory diseases. R-3750 leverages Rise Therapeutics' proprietary drug delivery platform to orally deliver targeted biological therapy that engages a specific receptor expressed on dendritic cells, reducing gut inflammation and improving gut membrane barrier integrity. The Phase 1 trial will be a single and repeat dose study assessing the safety and tolerability, drug exposure, and clinical activity of R-3750 in patients with mild to moderate ulcerative. The study will enroll up to 36 participants where clinical activity will be evaluated by improvement in ulcerative colitis disease severity and a variety of key biomarker and pharmacodynamic assessments. "Receiving IND clearance for R-3750 is an important accomplishment based upon our talented and motivated team at Rise, and we want to express our thanks to the NIH for supporting the research that led us to this milestone. This application brings us one step closer to revolutionizing how we treat debilitating diseases like IBD with targeted oral therapy that leverages natural microbiome pathways to reeducate immunological repertoires treating the root cause of disease," states Gary Fanger, President and CEO of Rise Therapeutics. "After establishing internal GMP manufacturing at Rise for clinical supply of R-3750, we are focusing on clinical execution to move beyond our initial proof-of-concept study, making synthetic biology medicine a reality for patients." About Rise Therapeutics Rise Therapeutics is an emerging, privately held 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. Learn more at . Contact: Faith Becker hr@risetherapeutics.com