How competitive can Roche be in the weight-loss drug market? – NBC New York

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Hello! Roche is one of several pharmaceutical manufacturers hoping to capitalize on the booming market for weight-loss drugs, currently dominated by Novo Nordisk and Eli Lilly.

But can the Swiss company develop drugs that can compete with this duopoly?

The answer is not yet clear.

We need to see more data from longer and larger clinical trials, which will likely take years to complete at Roche.

Last week, however, the company presented more early-stage data from its experimental anti-obesity injection and pill, which some analysts said raised doubts about how competitive those products might be when they hit the market.

Some analysts said the new results showed that both drugs – which Roche acquired in December through its nearly $3 billion acquisition of Carmot Therapeutics – caused more side effects than expected.

“We believe that investor enthusiasm for Roche's obesity franchise may now wane, as both the acquired [drugs] showed higher than expected [gastroinsteinal] side effects,” analysts at Jefferies said in a statement on Wednesday, pointing out that the drug dose given to patients was drastically increased as part of the studies.

On Wednesday, Roche presented tolerability data from a phase 1 study of its oral drug CT-996, which is being developed to treat obesity and diabetes. The pharmaceutical company had previously stated that the once-daily obesity pill helped patients lose up to 7.3 percent of their weight within four weeks, compared with 1.2 percent for those who received a placebo.

This “competitive” weight loss appears to be due to “rapid” dose increases, which caused a high incidence of gastrointestinal side effects, according to the Jefferies analysts. However, they noted that these side effects could be mitigated by a slower dose increase.

“The true competitive profile [of the drug is] “This trend will only become apparent when data from larger Phase 2 trials become available,” the analysts write.

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

The analysts said that a group of patients who eventually received the lowest maximum dose of the pill – 90 milligrams – still experienced frequent nausea, “with limited effectiveness in weight loss.”

Another group of patients taking the highest maximum dose of the drug – 120 milligrams – with slightly smaller dose increases over time had nausea rates of 83 percent, vomiting of 33 percent and diarrhea of ​​50 percent, according to the JPMorgan analysts. The drug's tolerability at this dosing approach “does not appear to be competitive,” they said.

According to analysts, these values ​​are significantly higher than those of Novo Nordisk's oral semaglutide, the active ingredient in the weight-loss drug Wegovy, and Eli Lilly's experimental obesity pill orforglipron.

But the “purpose” of the pill study was to “get results quickly” and determine whether there were any unexpected problems with safety or efficacy, said Manu Chakravarthy, head of product development for cardiovascular, renal and metabolic diseases at Roche, on Thursday on CNBC's “Fast Money.”

For this reason, the company has moved “a little faster in titration than one normally does in later-stage studies,” he noted.

He added that the rate 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 haven't seen anything unexpected in terms of safety, which actually gives us a lot of confidence to move the program forward into phase two,” Chakravarthy said, noting that Roche plans to start mid-stage trials in 2025.

He added that Roche does not believe that slowing the titration will reduce the effectiveness of the company's injection or pill, because both products showed similar weight loss trajectories, even with slower or smaller dose increases, Chakravarthy said.

“If we slow down the titration, we would rather expect accountability to improve even further,” Chakravarthy told CNBC.

In May, Roche announced that its CT-388 injection helped patients with obesity lose 18.8% of their body weight. more weight compared to those who received a placebo in the Phase 1 trial after 24 weeks. The company hopes the drug will eventually demonstrate 25% weight loss in later trials, Chakravarthy told Fierce Biotech on Wednesday.

Feel free to send tips, suggestions, story ideas and data to Annika at [email protected].

Healthtech latest: Oura enters metabolic health market with acquisition of Veri

Smart ring maker Oura is going beyond sleep, exercise and stress monitoring and is tapping into a brand new market: metabolic health.

Oura announced last week that it had agreed to acquire Veri, a company that uses continuous glucose monitors to help users eat healthier and lose weight. Oura did not disclose terms of the deal.

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

CGMs have traditionally been prescribed to people with diabetes, but Abbott and Dexcom recently launched over-the-counter versions that are also available to adults who don't take insulin. Both companies offer the sensors for less than $100 a month.

Oura is the latest company to stake its claim in this emerging market.

The company's smart ring can already help users monitor their sleep, heart health, exercise and stress, so expanding to metabolic health was a logical next step, Oura CEO Tom Hale wrote in a blog post. About 97 percent of Oura members said they wanted to understand how their bodies react to food, Hale added.

The company had already agreed to integrate its data into Veri as part of a partnership last year. As part of the agreement, a “significant portion” of Veri's employees, including the founders, will move to Oura. Existing Veri customers will be able to use the platform until the end of the year.

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

“Our goal is to create an ecosystem of other inputs like CGMs that feed into the Oura experience to make it even more personal and actionable,” he said.

As a first step, Oura will launch a new feature called “Meals” through Oura Labs this fall, according to a press release. Oura Labs will allow users to test new features and provide feedback before they are rolled out more widely. The Meals feature will allow users to track what they eat to gain insights into how it impacts their sleep, recovery, and stress.

Feel free to send tips, suggestions, story ideas and data to Ashley at [email protected].