In this articleNVOFollow your favorite stocksCREATE FREE ACCOUNTMichael Siluk | UCG | Universal Images Group | Getty ImagesLosing weight with GLP-1 drugs is only half the battle. Keeping it off long term has proved even harder.Factors such as side effects, high out-of-pocket costs, injection fatigue and stigma around obesity treatment drive troves of patients – some studies estimate roughly half or more – to stop GLP-1s within a year and risk regaining the weight they lost. Years from now, Vivani Medical believes a tiny GLP-1 implant placed under the skin could help address that problem. The biotech company is in the early stages of developing an experimental implant of semaglutide, the active ingredient in Novo Nordisk’s blockbuster obesity injection Wegovy and diabetes counterpart Ozempic. The Danish pharma giant announced on Tuesday a new agreement with Vivani to evaluate its lead semaglutide implant, NPM-139. Vivani envisions patients would initially use it as a maintenance treatment rather than a therapy people take when they start GLP-1s. Under that approach, patients would first reach an appropriate dose of semaglutide using existing injections or pills, then potentially switch to the implant for longer-term treatment.If everything goes to plan, Vivani believes the device could eventually serve as a convenient option administered just twice a year — or even once annually — to help patients stay on therapy and maintain weight loss, while potentially reducing some side effects associated with existing GLP-1 medicines. “It’s really critical to have options that make it easy for people to get the full benefits of these treatments and to not discontinue at the rates we’re seeing,” Vivani President and CEO Adam Mendelsohn said in an interview. “What these drugs are capable of is not being carefully taken advantage of right now.” But the implant is still at least several years out from living up to that promise. The device needs to clear several clinical trials and regulatory hurdles before reaching patients. Some endocrinologists and other doctors said there could be demand for an implant, but they also want to see concrete data on how effective it will be compared with existing medicines and how well patients will tolerate it. They also raised questions about whether providers would be willing to adopt it. “I really want to see that this is going to work well and deliver results for patients, but I also want to see that it’s something that my patients can stay on long term,” Dr. Miranda Stiewig-Rapp, director of UC Davis Health’s Obesity Clinic, said in an interview. “I’m probably overall very skeptical, but I’m happy to be proven wrong.”The potential cost of the implant and whether insurers would cover it if approved also remain unclear. That makes it difficult to estimate what the implant’s sales could be in a GLP-1 market that some analysts expect could exceed $100 billion by the early 2030s.In a statement to CNBC, Novo Nordisk confirmed the agreement with Vivani and said it is focused on complementing its internal research and development efforts with external innovation.How the GLP-1 implant works Vivani’s long-acting semaglutide implant is essentially a tiny titanium reservoir filled with a certain dose of the medicine. The company intends to develop implants that deliver different dosages of semaglutide, allowing a patient and their doctor to select which one is best to switch to after an injection or a pill. What makes the implant unique is a “specialized membrane” at one end of the device that contains millions of microscopic channels, or “straws,” through which drug molecules can leave the implant and enter the body, Mendelsohn said. He said those channels are designed to release semaglutide at a slow, steady rate over several months, which Vivani says could help reduce fluctuations in drug levels that can occur with periodic dosing of injections. Dr. Adam Mendelsohn holds an implant from Vivani.Courtesy: Jami Taylor | VivaniIf a p …
