Roche releases more data on weight loss drugs, injections | Wilnesh News

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good afternoon! Roche is one of several drugmakers hoping to join the booming weight-loss drug market Novo Nordisk and Eli Lilly and Company Currently dominant.

But can the Swiss company develop a drug that can compete with the duopoly?

The answer is unclear.

We need more data from longer, larger clinical trials, which may take Roche years to conduct.

But last week the company Provide more early dataMore early data Some analysts said this raised concerns about the competitiveness of these products once they enter the field.

Some analysts said the new results suggested the two drugs, which Roche acquired through its nearly $3 billion acquisition of Carmot Therapeutics in December, were causing higher-than-expected rates of side effects.

“We believe investors are cautious about Roche’s obesity pipeline given that both acquired (drugs) have shown higher-than-expected (gastrointestinal) side effects,” Jefferies analysts said in a note on Wednesday. The excitement may now be on hold.

For example, Roche on Wednesday released tolerability data from a Phase 1 trial of its oral drug CT-996, which is being developed to treat obesity and diabetes. The drugmaker previously said the once-daily diet pill helped patients lose 7.3% of their body weight over four weeks, compared with 1.2% for those taking a placebo.

Jefferies analysts said this “competing” weight loss appeared to be driven by “rapid” dose escalation, which led to frequent gastrointestinal side effects. But they note that these side effects can be mitigated by more gradual dose increases.

“The true competitive characteristics of (the drug) will not be visible until data from the large-scale Phase 2 trial are released,” the analysts wrote.

JPMorgan analysts were less optimistic in a note on Wednesday: “We are concerned about the ability to phase out the high incidence of gastrointestinal side effects,” they wrote.

One group of patients who ended up receiving the lowest maximum dose (90 mg) of the pill still experienced high rates of nausea and “had limited weight loss,” analysts said.

Another group of patients who took the highest dose (120 milligrams), with slightly lower dose increases over time, had 83% nausea, 33% vomiting and 50% diarrhea rates, JPMorgan analysts said. The drug’s tolerability under this dosing regimen “appears uncompetitive,” they said.

Analysts said those rates were significantly higher than those for Novo Nordisk’s oral semaglutide, the active ingredient in weight loss drug Wegovy, and Eli Lilly’s experimental obesity drug orforglipron.

But Manu Chakravarthy, Roche’s head of cardiovascular, renal and metabolic product development, told CNBC’s “Fast Money” that the “focus” of the study on the pill is to “fail fast” and determine whether Unexpected safety or effectiveness issues.

That’s why the company “titrated the regimen a little faster than usual” in late-stage trials, he noted.

He added that the incidence of gastrointestinal side effects was “very consistent” with other drugs in the same class as Roche’s pill, which mimics a hormone in the gut called GLP-1 to suppress appetite and regulate blood sugar.

“So we didn’t see any surprises in terms of safety, which actually gave us a lot of confidence … to move the project to Phase 2,” Chakravarthy said, noting that Roche plans to begin a mid-stage study in 2025.

He added that Roche does not believe that slowing down the titration will make the company’s shots or pills less effective. That’s because the two products showed similar weight loss trajectories, even with slower or lower dose increases, Chakravarthy said.

“If anything, as we slow down the titration, we expect further improvements in accountability,” Chakravarthy told CNBC.

In May, Roche said its injection CT-388 helped obese patients lose 18.8% of their weight After 24 weeks in the phase 1 trial, weight gain was seen in subjects taking placebo. Chakravarthy said the company hopes the drug will eventually prove in late-stage trials to reduce body weight by 25% Tell Fierce Biotech Wednesday.

Please feel free to send Annika any tips, suggestions, story ideas and data: annikakim.constantino@nbcuni.com.

Oura declare Last week, the company agreed to acquire Veri, a company that uses continuous glucose monitors to help users eat healthily and lose weight. Oura did not disclose terms of the deal.

A continuous glucose monitor (CGM) is a small sensor that pierces the skin to track a user’s real-time blood sugar levels. Glucose is the sugar we get from food and is the body’s main source of energy. Everyone’s blood sugar levels fluctuate, but consistently high levels can lead to more serious health problems, such as metabolic disease, insulin resistance, and heart disease.

CGM has long been prescribed to people with diabetes, but Abbott and Dexcom have recently introduced over-the-counter versions that can be used by any adult who doesn’t take insulin. Both companies offer sensors for less than $100 per month.

Oura is the latest company seeking to gain a foothold in this emerging market.

Oura CEO Tom Hale writes in the book that the company’s smart rings already help users track their sleep, heart health, exercise and stress, so expanding into metabolic health is a natural next step. a blog post. Hale added that about 97 percent of Oura members say they want to know how their bodies react to food.

The company previously agreed last year to integrate its data into Veri through a partnership. As part of the deal, a “significant portion” of Veri’s employees, including its founders, will join Oura. Existing Veri customers can use its platform until the end of the year.

Hale said Oura’s acquisition of Veri is just the beginning of the company’s plans in the metabolic health market.

“Our goal is to create an ecosystem of other inputs, such as CGM, integrated into the Oura experience to make it more personal and actionable,” he said.

According to reports, as a first step, Oura will launch a new feature called “Meals” through Oura Labs in the fall. release. Oura Labs is a place where users can test new features and provide feedback before wider release. The meals feature will allow users to track what they eat to gain insights into how it affects their sleep, recovery and stress.

Please feel free to send any tips, suggestions, story ideas and data to Ashley at ashley.capoot@nbcuni.com.