Rise Therapeutics LLC

ROCKVILLE, Md., Oct. 23, 2024 /PRNewswire/ -- 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. "This funding package from NIH will help drive our transition to large scale GMP manufacturing," stated Dr. Gary Fanger, President and CEO of Rise Therapeutics. "With four different products progressing through Phase 1 proof-of-concept clinical studies, our ability to seamlessly transition those programs into pivotal Phase 2/3 studies is critical for Rise Therapeutics' evolution to a late-stage clinical company. This funding is an important component to that transition, and we appreciate the support by NIDDK for helping enable us to develop R-3750 as an innovative new drug candidate." About R-3750 Being an oral immunotherapy, R-3750 represents a novel breakthrough in the way we treat Inflammatory Bowel Disease (IBD). Rise Therapeutics has utilized its proprietary synthetic biology approach to develop R-3750, an immunologically-directed microbiome medication, orally administered as a capsule for the treatment of IBD. Affecting greater than 3 million adults in the US each year, IBD is composed of two chronic inflammatory diseases of the gastrointestinal tract: Crohn's disease (CD) and ulcerative colitis (UC). IBD is a lifelong disease that currently has few treatments available, and of those treatments, many have debilitating side effects and risks. Rise Therapeutics' R-3750 therapy represents a novel immune regulatory approach for mediating anti-inflammatory control in the gut and a promising solution for mitigating colitis. 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: [email protected] SOURCE Rise Therapeutics WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

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