Adam Mendelsohn, CEO of Vivani Medical, said that they are committed to promoting GLP-1 subcutaneous implantation into the diabetes market. The drug device delivery system developed by the company for subcutaneous implantation of exenatide implants, codenamed NPM-119, is based on the NanoPortal technology platform. The internal space of the implant is completely filled with drugs, and the release of drugs is controlled through a nano porous membrane at the end, achieving real-time control of the release speed and time, with a maximum of 6 months of long-term release.
The implant is operated by a doctor and implanted subcutaneously in the upper arm. The procedure takes only a few minutes to complete, and only 2-3 times within a year, greatly improving compliance.
NPM-119 will be declared using the 505b (2) pathway for original research data borrowing. In January 2023, the company has initiated a Phase II clinical trial of NPM-119 called LIBERATE-1 (NCT05670379). The clinical protocol is directly paired with Bydureon [Exenatide Long acting (1 week)], with a long-term effect of 3 months. Bydureon was originally developed by AstraZeneca. The company stated that clinical trial data will be generated by the end of the year.
One NPM-119 implant that delivers approximately 52 microgram/day of exenatide for a duration of 3 months will be inserted subdermally just under the skin of the upper outer arm.
Combination Product: NPM-119 (exenatide implant)
NPM-119 is a drug:device combination that delivers steady levels of exenatide, a glucagon-like peptide-1(GLP-1) receptor agonist, for an extended period of time following subdermal insertion.
Active Comparator: Bydureon BCise (exenatide extended release)
2 mg subcutaneous injection every week for a duration of 3 months
Drug: Bydureon BCise (exenatide extended release)
glucagon-like peptide-1 (GLP-1) receptor agonist
At present, GLP-1 target has several drugs on the market, including AstraZeneca exenatide, Novo Nordisk's lilalutide, Somaglutide, Sanofi's lisenatide, and the long-term effect of injection once a week, including Lilly's dulaglutide, exenatide, Somaglutide, etc. The players involved are big pharma.
There is another story about the Exenatide implant
Intrcia Therapeutics is a pioneer in the development of Exenatide, with a valuation of up to $5 billion, setting the highest valuation history for an unlisted company. It can be described as a true unicorn, with the well-known Bill Gates Melinda Fund among investors. The company's development of the Isenatide implant, ITCA 650, was first submitted to the FDA for approval in 2017. However, due to safety issues (cardiac risk) and production issues, it was rejected for listing. The company reapplied for listing in 2020 and was rejected again. However, there seems to be a turning point regarding whether ITCA 650 can be successfully listed. In February 2023, the FDA organized an expert group meeting to further discuss, As of February 24th, Intarcia Therapeutics can answer inquiries from the expert group.
The FDA has extremely strict requirements for cardiovascular risks involved in the development of new drugs for metabolic diseases, even requiring CVOT events. The heart risk of ITCA 650 is clearly difficult to meet the FDA's marketing requirements. Does the warning from ITCA 650 also raise a question for NPM-119, whether the safety is a problem with this type of implant or just with ITCA 650 itself, depends on the clinical trial data of NPM-119.
However, it is hard to say how big a storm GLP long-term implants will stir in the type 2 diabetes market after they are launched. Personally, I believe that exenatide is definitely a substitute. The blockbuster drugs in the GLP-1 or type 2 diabetes market are Lilly's dulaglutide and Novo Nordisk's Somaglutide, and Somaglutide has long-term injection and once a day oral administration (the first and only GLP-1 oral administration at present). In addition, clinical trials have confirmed that Somaglutide has a risk of CVOT events, which cannot be compared solely by improving long-term injection. In addition, Lilly and Novo Nordisk are veteran players in the field of diabetes, and the field of diabetes can be said to be one of the most difficult areas for biotechnology to pry big pharma.