Dive Brief:
- A closely watched obesity pill being developed by Roche helped people in a small Phase 1 trial lose 7.3% of their body weight over four weeks when taken once daily — 6.1 percentage points more than those given a placebo, the company said Wednesday.
- The data comes two months after the Swiss drugmaker disclosed trial results from another obesity drug in its pipeline, which showed the once-weekly injection helped reduce body weight by 19% over six months. Roche disclosed more detailed data for that drug, indicating none of the trial participants stopped taking it due to side effects — a reason users might quit taking Wegovy or Zepbound.
- The two drugs came from Roche’s $2.7 billion acquisition of biotechnology startup Carmot Therapeutics in December. The deal was part of a rush by pharmaceutical companies to enter a market estimated to be worth more than $100 billion annually by early next decade.
Dive Insight:
The first months of 2024 have featured a flurry of data from companies with obesity drugs in various phases of development trying to catch up to Novo Nordisk’s blockbuster Wegovy and Eli Lilly’s Zepbound. Roche, which hasn’t been as active in metabolic medicine, is a surprise entrant in this chase, but may have made a savvy choice in buying Carmot for its pipeline of drugs to treat obesity and diabetes.
With Wegovy and Zepbound established in the market, and proven to help with other complications of obesity like heart disease and sleep apnea, would-be competitors have a high bar to clear.
One way could be oral delivery, as both Wegovy and Zepbound are once-weekly injectables. Roche, Pfizer and Viking Therapeutics are among those trying to launch an oral alternative, although Novo and Lilly both have oral drugs in late-stage development.
The trial data released Wednesday for Roche’s drug, called CT-996, comes from a small dosing trial in which the drugmaker sought to assess the pill’s safety and tolerability, as well as measure the GLP-1 drug’s biological activity and how well it helped people lose weight. The data is from a group of people with obesity but without diabetes, while other parts of the trial will assess its use in people who also have diabetes.
In addition to the weight loss data, Roche said the drug’s activity in the body supported once-daily use and didn’t appear to be affected by consumption of high-fat meals or when taken while fasted, supporting flexible dosing times.
Roche described the 7.3% weight loss as “clinically meaningful.” However, the result will need to be confirmed by longer trials. Zepbound and Wegovy gained approval on trials in which volunteers took the therapeutics for more than a year.
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- Source: https://www.biopharmadive.com/news/roche-carmot-oral-obesity-drug-phase1-data/721588/