Rockville, MD. Rise Therapeutics announced today that the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) of the National Institutes of Health (NIH) has awarded a two-year Small Business Innovation Research (SBIR) Phase II award to fund the company’s further proof-of-concept testing of R-2487. R-2487 is Rise’s lead therapeutic candidate that represents a novel breakthrough approach for the treatment of Type 1 Diabetes (T1D). The promising features of this novel cellular synthetic biology medicine are focused on combining the safety of a probiotic with the functionality and specificity of target biological immunotherapy.
T1D is an autoimmune disease caused by autoreactive T-cell-mediated destruction of islet beta cells. Genetic predisposition coupled with environmental factors are important elements in the development of T1D. The incidence and prevalence of T1D are increasing in the world, with an incidence of 15 per 100,000 people and a prevalence of 9.5%. In the US, there are about 1.6 million Americans living with T1D, including about 200,000 youth; 64,000 people are newly diagnosed each year with 5 million people expected to have T1D by 2050. Currently, there is no cure for T1D. Individuals with T1D must continuously and carefully balance insulin intake with eating, exercise, and other activities. Therefore, R-2487 is an attractive treatment option that offers itself as an effective modality to correct the underlying causative factors associated with T1D.
“With research demonstrating curious differences in the intestinal microbial profile of Type 1 Diabetes patients, we believe R-2487 can act as a life changing therapeutic for those living with Type 1 Diabetes,” said Dr. Gary Fanger, President and CEO of Rise Therapeutics. "We are grateful that, with the generous support of the NIH, we are able to advance product development of R-2487, a therapy that we believe will provide a profound medical advancement for treating Type 1 Diabetes."
R-2487 works by upregulating T regulatory (Treg) cells. With current treatments of T1D relying on people with the disease to continuously and carefully balance insulin intake alongside their daily activities, a more convenient and reliable method is needed. Thus, the capacity to stimulate Tregs independent of knowing the antigen specificity for the disease poses an attractive therapeutic approach.
Development of R-2487 is based on Rise Therapeutics’ novel drug delivery platform that enables oral delivery of immunotherapy medicines. The platform, called TriPartite X (TPX), is a novel DNA assembly approach that enables creation of cellular synthetic biology medicines to escort targeted protein therapies to the site of action, the intestinal tract. TPX enables the drug industry to step away from regular injections and infusion strategies for a more convenient ‘pill-based’ oral delivery perspective for biological medicines. TPX can be utilized to deliver a variety of protein-based drugs, including complex immunotherapy applications,
Rise Therapeutics is an experienced oral therapeutics developer focused on launching promising products to the patients who need them the most. Rise Therapeutics has a robust oral therapeutics pipeline and is proud to partner with The University of Florida and the NIH on this exciting program.
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. Unlike traditional biological therapies which require injection or infusion, Rise Therapeutics’ delivery platform allows simple, convenient, and cost-effective oral capsule delivery of targeted protein therapy. The drug development focus at Rise is driven by new microbiome-related discoveries enabling development of rapidly advancing life changing cellular-based medicines to the market for the treatment of inflammation, autoimmunity, cancer, and infection. For more information, go to www.risetherapeutics.com.