Category: Verdiva

  • Verdiva ends mid-stage study of oral GLP-1 amid ‘market evolution’

    Verdiva ends mid-stage study of oral GLP-1 amid ‘market evolution’

    Verdiva Bio has pulled the plug on a Phase 2 study testing its lead GLP-1 drug candidate as an oral maintenance option for patients with overweight and obesity but will continue developing the medicine for other weight loss indications.

    The discontinuation was a “business decision” and not based on safety findings, according to a federal clinical trials database. The study was testing VRB-101 (oral ecnoglutide) in patients who had undergone at least six months of subcutaneous treatment with Novo’s semaglutide or Eli Lilly’s tirzepatide and had achieved 10% weight loss or greater. Eight patients were enrolled at the time of the study’s cancellation.

    “We have refined our clinical development plans for VRB-101 in light of market evolution,” a Verdiva spokesperson told BioSpace in an email on Wednesday, responding to questions about the biotech’s decision to discontinue the mid-stage trial.

    Verdiva licensed VRB-101 from Chinese company Sciwind Biosciences, paying $70 million upfront and putting more than $2.4 billion on the line in milestone payments. The deal was signed in 2024 but was revealed in January 2025, alongside the announcement of Verdiva’s launch and closing of a $411 million series A round.

    Aside from VRB-101, Verdiva also obtained from Sciwind two amylin analogs, one designed as a weekly oral treatment and the other a long-acting subcutaneous injection.

    A subcutaneous version of ecnoglutide is approved for diabetes and chronic weight management in China, where Pfizer owns the drug’s commercialization rights through a February agreement with Sciwind. The pharma put up to $495 million on the line for ecnoglutide.

    In June, data from a head-to-head Phase 2 trial in China showed that subcutaneous ecnoglutide elicited 35% greater weight loss than Novo’s semaglutide, which is approved for the indication in the U.S. as Wegovy. At 20 weeks, patients on ecnoglutide lost 12.8% of their body weight on average, versus 9.5% in semaglutide controls, with the difference reaching statistical significance, Sciwind said. The ongoing trial, called SLIMMER-UP-SWITCH, enrolled 163 adults with obesity who were randomly assigned to receive ecnoglutide or semaglutide. The study’s primary outcome is change in body weight.

    Verdiva now hopes to bring the drug’s oral version to the market. Despite the discontinued mid-stage study, the biotech is actively advancing VBR-101—both as a monotherapy and in combination with the company’s two amylin assets. A separate Phase 2 study of VRB-101, dubbed EVOLVE-2, wrapped up in July, though the biotech has yet to release data.

    “We continue to develop VRB-101 as a potential monotherapy, while ensuring the program generates the data needed to inform its potential role alongside our amylin portfolio,” the Verdiva spokesperson said. “Data from the EVOLVE-2 study is being assessed and we’ll provide an update on the clinical trial when we can.”

    With its Sciwind-originated pipeline, Verdiva seeks to compete in the crowded obesity arena, currently dominated on both the injectable and oral fronts by Novo and Lilly.