Terrestrial Bio announced today that it dosed the first patients in a Phase I clinical trial evaluating its patch that delivers GLP-1 therapeutic semaglutide.
Boston-based Terrestrial (formerly Vaxess Technologies) is evaluating VX-201, a needle-free microarray patch (MAP) in the trial. The company designed its MAP technology features a soluble microarray with tips that gradually dissolve into the body after removal. These tips release their payload of therapeutics over time, mimicking how natural infections interact with the body.
Each patch, applied to the skin with a spring-loaded applicator, has its microneedle base dissolve within five minutes of application. It then deploys semaglutide-loaded microneedle tips into the skin’s upper layers. MAP technology removes sharps, eliminates the need for refrigeration and enables self-administration for user comfort. Clinical findings shared at ADA recently highlighted the platform’s capabilities in GLP-1 delivery.
Terrestrial Bio’s study takes place at a single U.S. site, enrolling approximately 62 health adults with a body mass index of 25–40 kg/m², ages 18–60. A single ascending dose phase enrolls 32 subjects across two dose cohorts of 0.25 mg and 0.5 mg. It randomizes patients 1:1 to receive either VX-201 or Wegovy subcutaneous (SC) injection as a reference comparator.
A multiple-dose phase will enroll 30 subjects who first complete a 12-week titration on semaglutide SC. Then, it randomizes them 1:1 to receive either VX-201 or semaglutide SC at maintenance doses of 1.7 mg and 2.4 mg for an additional eight weeks. It has primary endpoints of safety and tolerability, including skin sensitivity at the patch application site.
Commentary from Terrestrial Bio leadership
Rachel Sha, CEO of Terrestrial Bio, said:
“GLP-1 therapies have transformed how we treat metabolic disease, but injecting GLP-1s can be painful for patients, while cold-chain requirements for shipments limit access and drive up costs. The Tacterra platform has the potential to offer a much more patient-friendly experience. Starting our first in human trials brings us one step closer to making patch-based GLP-1 therapy a reality.”
Lynda Tussey, chief development officer of Terrestrial Bio, said:
“VX-201 is designed to deliver equivalent systemic semaglutide exposure with a patch-based experience patients may find more acceptable than traditional injection, which is a meaningful differentiator in the obesity treatment landscape. Our preclinical work gave us confidence in the Tacterra microarray patch, and we’re now carefully and systematically generating the clinical evidence we need to advance.”
