Skye Bioscience's obesity drug fails to meet main goal of mid-stage study (updated)

Skye Bioscience

06/10/2025 12:31

Corrects paragraph 3 to say Skye's eye drug failed in "mid-stage study", not "late-stage study"

Oct 6 (Reuters) - Skye Bioscience SKYE.O said its experimental treatment failed to achieve the main goal of significantly reducing weight in adults with obesity in a mid-stage study, sending the drug developer's shares slumping more than 61% on Monday.

Patients receiving the drug, nimacimab, lost 1.26% of their body weight, when adjusted for placebo rates, lower than the company's expectations of a 5% to 8% reduction.

San Diego, California-based Skye has been banking on nimacimab, a weekly subcutaneous injection, to fuel growth after its eye disease drug candidate failed in a mid-stage study last year.

The company also tested nimacimab in combination with Novo Nordisk's NOVOb.CO semaglutide, the active ingredient in the Danish firm's weight-loss drug Wegovy.

Nimacimab is designed to block the CB1 protein that aids in breaking down stored fat and regulating appetite-related hormones, which can help in sustained weight reduction without loss of muscle.

The study, which enrolled 136 overweight adults, showed that patients who took nimacimab and semaglutide lost 13.2% of their body weight on average, compared with 10.25% for those on semaglutide alone after 26 weeks.

The combination helped patients preserve more lean mass compared with semaglutide alone, it said.

Roughly a dozen companies, including Eli Lilly LLY.N, Regeneron REGN.O and smaller rivals Scholar Rock SRRK.O and Veru VERU.O, are testing treatments that target proteins tied to muscle preservation or growth.

These treatments, being tested in combination with Novo and Lilly's drugs, could generate more than $30 billion in sales by 2035.

Skye said no neuropsychiatric issues linked to nimacimab were reported in the study. It expects data from a 26-week extension of the study in the first quarter of 2026.

 (Reporting by Padmanabhan Ananthan and Mariam Sunny in Bengaluru; Additional reporting by Bhanvi Satija in London; Editing by Sriraj Kalluvila and Shilpi Majumdar)

 ((Padmanabhan.Ananthan@thomsonreuters.com;))