The headquarters of multinational pharmaceutical company Roche in Madrid, Spain, December 27, 2021.
Christina Arias | Cover | Getty Images
A version of this article first appeared in CNBC’s Healthy Returns newsletter, which delivers the latest healthcare news straight to your inbox. Subscribe here to receive future issues.
Hello! Roche It is one of several pharmaceutical companies hoping to get into the fast-growing market for weight-loss drugs. Novo Nordisk and Eli Lilly Currently dominant.
But can Swiss companies develop medicines that can compete with the duopoly?
The answer is not yet clear.
More data is needed from longer, larger clinical trials, which Roche will likely take years to conduct.
But the company released further early-stage data last week on its experimental obesity treatment injection and pill, raising concerns from analysts about how competitive those products would be if they entered the space.
Some analysts said the new findings suggested that both drugs, which Roche acquired through its purchase of Carmot Therapeutics in December for about $3 billion, caused a higher rate of side effects than expected.
“We believe investor enthusiasm for Roche’s obesity drugs may now subside, given that both acquired drugs showed stronger-than-expected (gastrointestinal) side effects,” Jefferies analysts said in a note on Wednesday, noting that patients in clinical trials were given aggressively increased doses of the drug.
For example, Roche on Wednesday released tolerability data from a Phase 1 trial of CT-996, an oral drug it is developing to treat obesity and diabetes. The company previously said that taking the obesity drug once a day helped patients lose up to 7.3% of their body weight within four weeks, compared with 1.2% in patients who received a placebo.
According to analysts at Jefferies, this “competitive” reduction appears to have been caused by a “rapid” increase in dosage, which resulted in frequent gastrointestinal side effects, but they noted that a more gradual increase in dosage could potentially mitigate these side effects.
“The drug’s true competitive position remains to be seen until data from a larger Phase 2 trial are released,” the analysts wrote.
Analysts at JPMorgan were less optimistic in a report on Wednesday, writing that they were “concerned about the ability to phase out the high rates of gastrointestinal side effects.”
The analysts said that the group of patients who ended up receiving the tablet’s minimum and maximum dose of 90 milligrams still experienced higher rates of nausea, but that “the effect of weight loss was limited.”
In another group of patients who received the drug’s maximum dose of 120 milligrams and then gradually increased the dose, 83 percent of patients experienced nausea, 33 percent experienced vomiting and 50 percent experienced diarrhea, according to JPMorgan analysts. The drug’s tolerability at that dose “does not appear to be competitive,” the analysts said.
Analysts said those rates were significantly higher than those seen with Novo Nordisk’s oral semaglutide, the active ingredient in weight-loss drug Wegovy, and Eli Lilly’s experimental obesity treatment Orforgliplon.
But the “primary objective” of the study on the pill is to “fail fast” to determine whether there are any unexpected safety or efficacy issues, Manu Chakravarthy, head of cardiovascular, renal and metabolism product development at Roche, told CNBC’s “Fast Money” on Thursday.
That’s why the company has adopted a “slightly more rapid than usual titration plan” in its late-stage trials, he noted.
He added that the incidence of gastrointestinal side effects was “broadly comparable” to other drugs in the same class as the Roche pill, which mimics a gut hormone called GLP-1, which suppresses appetite and regulates blood sugar levels.
“We didn’t see anything unexpected in terms of safety, which gives us great confidence in moving the program forward into phase two,” Chakravarthy said, adding that Roche plans to begin a mid-stage study in 2025.
He added that Roche doesn’t believe that slowing titrations would make its shot or tablet less effective, because both products showed similar dose-reduction trajectories when titrations were delayed or doses were reduced, Chakravarthy said.
“If anything, we can expect to see greater accountability if we slow down the rate of titration,” Chakravarthy told CNBC.
Roche announced in May that its injectable CT-388 increased weight loss in obese patients by 18.8% compared with those who received a placebo after 24 weeks of a Phase 1 trial. Chakravarthy told Fierce Biotech on Wednesday that the company hopes the drug will ultimately show a 25% weight loss effect in later-stage trials.
If you have any tips, suggestions, story ideas or data, please feel free to send them to Annika at annikakim.constantino@nbcuni.com.
Healthcare Tech Update: Oura Acquires Veri to Enter Metabolic Health Market
Smart ring maker Oura is moving beyond sleep, exercise, and stress tracking into an entirely new market: metabolic health.
Oura announced last week that it had agreed to acquire Veri, a company that uses continuous glucose monitors to help people eat healthier and lose weight. The company did not disclose terms of the deal.
A continuous glucose monitor (CGM) is a small sensor that is inserted under the skin to track a user’s blood glucose levels in real time. Glucose is sugar obtained from food and is the body’s main source of energy. Everyone’s blood glucose levels fluctuate, but consistently high blood glucose levels can lead to more serious health issues, including 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 available to any adult who doesn’t take insulin, and both companies offer sensors for less than $100 per month.
Oura is the latest company looking to establish itself in this emerging market.
The company’s smart ring already helps users track sleep, heart health, exercise, and stress, so expanding into metabolic health was a natural move, Ola CEO Tom Hale said in a blog post. About 97% of Ola members say they want to know how their bodies react to food, Hale added.
The company agreed to integrate its data with Veri through a partnership last year. As part of the deal, a “significant portion” of Veri’s employees, including its founders, will join Oura. Existing Veri customers will be able to use the platform until the end of the year.
Hale said Orla’s acquisition of Veri is just the beginning of the company’s plans in the metabolic health market.
“Our goal is to build out an ecosystem of other inputs, such as CGM, that can feed into the Oura experience to make it even more personalized and actionable,” he said.
As a first step, Oura plans to introduce a new feature called “Meals” in the fall through Oura Labs, where users can test and provide feedback on new features before they are released more broadly, according to the release. The Meals feature will allow users to track what they eat to gain insights into how it impacts sleep, recovery and stress.
If you have any tips, suggestions, story ideas or data, please feel free to send them to Ashley at ashley.capoot@nbcuni.com.
