Microbiotica has announced positive findings from its phase 1b MELODY-1 trial of MB097, an oral precision microbiome co-therapy being developed for advanced melanoma.

The study met all primary and secondary objectives, with the company reporting that MB097 was safely combined with pembrolizumab and showed encouraging early signs of efficacy in a population with primary resistance to anti-PD-1 therapy.

The international trial enrolled 41 patients across the UK, France, Italy and Spain. Participants received MB097 alongside pembrolizumab for up to six months, with half also given vancomycin preconditioning to assess whether it improved bacterial engraftment.

Microbiotica said the nine-strain bacterial consortium demonstrated robust engraftment, particularly in those receiving vancomycin.

Dr Pippa Corrie, National Co-ordinating Investigator for the study, said: “There is increasing evidence that the microbiome plays a crucial role in patients’ response to immune checkpoint inhibitors. Clinical benefit has been reported with faecal microbiota transplantations (FMT), while MB097 capsules taken orally each day affords an easy and reproducible way of modifying the microbiome.

She added: “The MELODY-1 study results show that MB097 is well tolerated, with encouraging early signs of efficacy in a very difficult-to-treat metastatic melanoma patient population with primary resistance to anti-PD-1 based immunotherapy, in whom there is a significant unmet need.”

Novo Nordisk has presented new sub-analyses from the phase 3 OASIS 4 trial at ECO2026, showing that oral semaglutide 25mg tablets delivered substantial weight loss and improvements in mobility for adults living with obesity compared with placebo.

The company reported that 28.8% of adults taking semaglutide tablets were early responders, defined as losing at least 10% of body weight by week 16. This group achieved 13.2% weight loss at week 16 and an average of 21.6% by week 64.

Those who did not meet early response criteria still recorded 11.5% weight loss by week 64, meaning both groups achieved clinically meaningful reductions.
Professor Partha Kar, Consultant Diabetes & Endocrinology, Portsmouth, said: “Obesity management isn’t a one-size-fits-all process. It’s nuanced, and individual responses can differ quite markedly.”

A separate analysis showed that 77.3% of people with poor physical function at baseline experienced clinically meaningful improvements in mobility and bodily pain scores when taking semaglutide tablets, compared with 42.9% on placebo. Weight loss in this group was similar to that seen across the overall treatment arm.