Roche Obesity Pill Achieves Positive Results in Early-Stage Trial -- 3rd Update

By Dominic Chopping and Helena Smolak

Roche Holding said a new weight-loss pill under development achieved positive results in an early-stage clinical trial, bolstering the company's efforts to enter the booming obesity market after another of its drugs showed weight-loss efficacy in May.

The Swiss pharmaceutical company is trying to get a slice of the market for drugs to treat obesity and diabetes currently dominated by Novo Nordisk and Eli Lilly. It entered the race through its $3 billion-plus purchase of Carmot Therapeutics, which gave Roche access to both oral and injectable drug candidates.

Roche said one of the experimental drugs it acquired through the Carmot deal--an orally administered drug called CT-996 which is being developed to treat both type 2 diabetes and obesity--showed clinically meaningful weight loss after four weeks of treatment in a Phase 1 study.

The oral drug is a more cost effective option for the company to develop, but in an increasingly-crowded obesity market Roche is eyeing combination therapies that could see patients transition from an injectable treatment to an oral form which might help maintain weight-loss, Manu Chakravarthy, Roche's Head of Product Development for Cardiovascular, Renal and Metabolic, said in an interview.

He said that by taking a broader approach to managing weight, the company hopes to appeal to a larger target population of overweight patients rather than by only addressing the needs of people with obesity.

Although Phase 1 trials are only early-stage tests, the data are encouraging and suggest a competitive profile, Jefferies analysts said in a note to clients. More details and data from a wider patient population will likely be needed, while gastrointestinal side effects will also be scrutinized, they said.

Still, investors are keen to reward companies that show even early potential in an obesity market that analysts say could be worth well north of $100 billion in annual sales. The blockbuster success of Novo Nordisk's Wegovy weight-loss drug has seen demand far outstrip supply and sent the Danish firm's valuation soaring to become Europe's most valuable company with a stock market valuation above that of the GDP of Denmark.

Roche shares traded 6.7% higher in afternoon European trade. Bryan Garnier Research analyst Bruno Bulic said the price move showcases the potential of the obesity market, as similar share reactions are typically only seen with positive late-stage trial data in the pharmaceutical industry.

Like Novo Nordisk's Wegovy, CT-996 works by mimicking a gut hormone known as GLP-1 to control blood sugar and suppress appetite. The safety and tolerability profile of the drug was consistent with other oral drugs of the same class and no unexpected safety signals were observed, the company said. The trial had only a few moderate nausea cases, no severe cases and no discontinuation of patients, Chakravarthy said.

The trial showed the once-daily drug helped patients lose 7.3% of their body weight within four weeks, versus weight loss of 1.2% in a placebo group, and results appeared unaffected by fasting or after high-fat meals--unlike some of its peers, Roche said.

At first look, the results are better than efficacy profiles reported by Novo Nordisk's injectable Wegovy and Eli Lilly's injectable Mounjaro, which both indicate 2%-4% weight loss at four weeks, Bryan Garnier Research analysts Bruno Bulic, Maria Vara and Oscar Haffen Lamm said in a note to clients.

A late stage trial by Novo Nordisk of its high-dose oral semaglutide drug last year showed weight loss of 15% after 68 weeks, but that was achieved alongside diet and physical activity.

Meanwhile, a Phase 1 trial of Novo Nordisk's next generation amycretin weight-loss pill showed weight loss of around 13% after 12 weeks, better than the 6% weight loss patients experienced after 12 weeks in a trial of its blockbuster Wegovy drug.

Eli Lilly's orforglipron obesity pill has shown weight loss of 15% after 36 weeks in a Phase 2 trial, with late-stage data expected next year.

Companies such as Pfizer, AstraZeneca and Viking Therapeutics are also developing oral GLP-1 weight-loss drugs but Roche's Chakravarthy said the competition shouldn't be viewed as a threat but as an indication of a vast unmet need to lower mortality rates. "Even if we have 10 drugs on the market, it would still not be enough," he said.

The company aims to release further data on its weight loss pill candidate in patients with obesity and type 2 diabetes in the next months and targets a phase 2 trial next year, Chakravarthy said.

Roche's CT-996 is the second experimental obesity drug to achieve positive results in an early-stage trial. In May, the company said another drug candidate, CT-388, which is administered via an injection, demonstrated efficacy in a Phase 1 study, by leading to significant weight loss in healthy adults with obesity compared to placebo.

Write to Dominic Chopping at [e-mail] and Helena Smolak at [e-mail]

(END) Dow Jones Newswires

07-17-24 1112ET