Rice University is spearheading the commercialization of a novel bioelectronic implant, ROGUE (Rx On-site Generation Using Electronics), designed to revolutionize the treatment of type 2 diabetes (T2D) and obesity. Backed by a $34.9 million grant from the Advanced Research Projects Agency for Health (ARPA-H), this innovative device aims to provide a cost-effective and patient-friendly alternative to traditional biologic therapies.
The ROGUE implant, developed by a multi-university research team led by Carnegie Mellon University, functions as a self-contained "living pharmacy." It houses cells engineered to produce T2D and obesity therapies directly in response to a patient's physiological needs. This approach seeks to address the high costs and adherence challenges associated with current treatments, particularly biologics like glucagon-like peptide 1 receptor agonists (GLP-1 RAs).
Key Features of the ROGUE Implant
The ROGUE device incorporates several key features designed to enhance treatment efficacy and patient experience:
- On-Demand Production: The implant produces therapies on-site, eliminating the need for frequent injections and improving patient adherence.
- Closed-Loop Bioelectronics: The device uses bioelectronics to support, monitor, and adjust drug production and dosing, ensuring optimal therapeutic levels.
- Cost-Effectiveness: With a target cost of goods below $1,000 for at least one year of therapy, ROGUE aims to significantly lower the costs of biologics-based treatments.
- Minimally Invasive Procedure: The technology is designed for rapid and cost-effective deployment via a minimally invasive procedure in an outpatient clinic.
Expert Perspectives
Omid Veiseh, professor of bioengineering and faculty director of the Rice Biotech Launch Pad, emphasized the transformative potential of ROGUE, stating, "ROGUE's innovative design combines efficient biological manufacturing, long-term durability and patient-friendly features that have the potential to transform the landscape of biologics delivery."
Jonathan Rivnay, a professor of biomedical engineering at Northwestern University, highlighted the potential of ROGUE to address the high costs associated with GLP-1 RAs, noting, "ROGUE's ability to produce glucagon-like peptide 1 receptor agonist (GLP-1 RA) on site will address these high costs and improve patient adherence by eliminating the need for frequent injections...GLP-1 RAs have proven effective in enhancing insulin secretion, reducing glucose levels and promoting significant weight loss, making them a first-line therapy for diabetes and obesity."
Tzahi Cohen-Karni, a materials science and bioengineer at Carnegie Mellon University, added, "Our approach enables on-demand production of therapeutics in a highly energy-efficient manner. This technology not only simplifies the delivery of life-saving medications but also enhances patient comfort and adherence. ROGUE's precision and adaptability offer a much-needed improvement in both treatment efficacy and patient experience."
Clinical Translation and Commercialization
The Rice Biotech Launch Pad is leading the commercialization efforts for ROGUE, with clinical trials slated to begin in the fifth year of the six-year project. This initiative is part of a broader effort to accelerate the translation of Rice University's health and medical technology discoveries into cures.
Paul Wotton, executive director of the Rice accelerator, noted, "With the Biotech Launch Pad, our goal is venture creation in parallel to the groundbreaking research at Rice and its collaborating institutions...This level of support speaks volumes to just how transformative these innovations could be, and therefore how important it is to facilitate their translation."
The ROGUE project is a collaborative effort involving multiple institutions, including Rice, Carnegie Mellon, Northwestern, Boston University, Georgia Institute of Technology, University of California Berkeley, the Mayo Clinic, and Bruder Consulting and Venture Group. This consortium brings together experts in various fields to co-design and develop the implant technology.