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Good afternoon! Roche is one of several drugmakers hoping to join the booming weight loss drug market, which Novo Nordisk and Eli Lilly are currently dominating.
But can the Swiss company develop drugs that can compete with that duopoly?
The answer isn’t clear yet.
We need to see more data from longer and larger clinical trials, which will likely take years for Roche to conduct.
But the company last week presented more early-stage data more early-stage data on its experimental obesity injection and pill, which some analysts said raised concerns about how competitive those products can be if they enter the space.
Some analysts said the new results showed that both drugs – which Roche acquired through its nearly $3 billion acquisition of Carmot Therapeutics in December – caused a higher rate of side effects than expected.
“Investor excitement for Roche’s obesity franchise may now take a pause, in our view, given both acquired [drugs] showed higher-than-anticipated [gastroinsteinal] side effects,” Jefferies analysts said in a note on Wednesday, noting that the trials aggressively increased patients’ dosages of the drug.
For example, Roche on Wednesday unveiled tolerability data from a phase one trial on its oral drug, CT-996, which is being developed to treat obesity and diabetes. The drugmaker previously said the once-daily obesity pill helped patients lose up to 7.3% of their weight within four weeks compared to 1.2% among those who received a placebo.
That “competitive” weight loss appears to be driven by “rapid” dose increases, which caused a high frequency of gastrointestinal side effects, according to the Jefferies analysts. But they noted that those side effects could be mitigated by a more gradual dosage ramp-up.
“The true competitive profile [of the drug is] not yet visible until the presentation of data” from larger phase two trials, the analysts wrote.
JPMorgan analysts were less optimistic in a Wednesday note: “We are concerned about the ability to titrate away the high rates” of gastrointestinal side effects, they wrote.
The analysts said a group of patients who eventually received the lowest maximum dose of the pill – 90 milligrams – still saw high rates of nausea “with limited weight loss efficacy.”
Another group of patients who took the highest maximum dose of the drug – 120 milligrams – with slightly lower dose increases over time had nausea rates of 83%, vomiting of 33% and diarrhea of 50%, according to the JPMorgan analysts. The tolerability of the drug under that dosing approach “looks uncompetitive,” they said.
The analysts said those rates are significantly higher than those seen with Novo Nordisk’s oral semaglutide, the active ingredient in the weight loss drug Wegovy, and Eli Lilly’s experiment obesity pill, orforglipron.
But the “whole point” of the study on the pill was to “fail fast” and determine whether unexpected safety or efficacy issues exist, Manu Chakravarthy, Roche’s head of product development for cardiovascular, renal and metabolic, said on CNBC’s “Fast Money” on Thursday.
That’s why the company went “a little bit quicker in the titration scheme than you normally” do in later-stage trials, he noted.
He added that the rates of gastrointestinal side effects are “very much in line” with other drugs of 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 nothing unexpected that we saw in 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 studies in 2025.
He added Roche doesn’t believe slowing down titration will make the company’s injection or pill less effective. That’s because both products showed similar weight loss trajectories, even with slower or lower dose increases, according to Chakravarthy.
“If anything, when we slow down the titration, we would expect the accountability to be even further improved,” Chakravarthy told CNBC.
In May, Roche said its injection, CT-388, helped patients with obesity lose 18.8% more weight compared to those who received a placebo after 24 weeks in the phase one trial. The company hopes that the drug will eventually demonstrate 25% weight loss in late-stage trials, Chakravarthy told Fierce Biotech on Wednesday.
Feel free to send any tips, suggestions, story ideas and data to Annika at annikakim.constantino@nbcuni.com.
Latest in health-care tech: Oura enters into metabolic health market with acquisition of Veri
Smart ring maker Oura is pushing beyond sleep, exercise and stress tracking and into a brand new market: Metabolic health.
Oura announced last week that it has agreed to acquire Veri, a company that uses continuous glucose monitors to help users eat healthier and lose weight. Oura did not disclose the terms of the deal.
A continuous glucose monitor, or a CGM, is a small sensor that pokes through the skin to track a user’s real-time glucose levels. Glucose is a sugar we get from food, and it’s the body’s main source of energy. Everyone’s glucose levels fluctuate, but consistently high levels can lead to more serious health problems like metabolic disease, insulin resistance and heart disease.
CGMs have historically been prescribed to patients with diabetes, but Abbott and Dexcom have recently released over-the-counter versions that are available to any adults that don’t take insulin. Both companies offer the sensors for less than $100 a month.
Oura is the latest company looking to stake its claim on this emerging market.
The company’s smart ring can already help users track their sleep, heart health, exercise and stress, so expanding to metabolic health was a natural next step, Oura CEO Tom Hale wrote in a blog post. Around 97% of Oura members have said they want to understand how their bodies respond to food, Hale added.
The company had previously agreed to integrate its data into 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 can use its platform through 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 ambition is to create an ecosystem of other inputs, such as CGMs, that feed into the Oura experience to make it even more personalized and actionable,” he said.
As a first step, Oura will introduce a new feature called “Meals” through Oura Labs in the fall, according to a release. Oura Labs is where users can test out new features and offer feedback before they launch more broadly. The Meals feature will allow users to track what they eat to gain insights about how it affects their sleep, recovery and stress.
Feel free to send any tips, suggestions, story ideas and data to Ashley at ashley.capoot@nbcuni.com.