The headquarters of Roche, a multinational pharmaceutical company, is seen on December 27, 2021 in Madrid, Spain.
Cristina Arias | Cover | Getty Images
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Good evening! Rosh It is one of several pharmaceutical companies hoping to join the booming weight-loss drug market, which Novo Nordisk and Eli Lilly Currently dominating.
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, larger clinical trials, which will likely take years for Roche to conduct.
But the company last week presented more early-stage data on its experimental injections and pills for treating obesity, which some analysts said raised concerns about how competitive these products would be if they entered the field.
Some analysts said the new results showed that both drugs — which Roche acquired through its acquisition of Carmote Therapeutics in December for about $3 billion — caused a higher rate of side effects than expected.
“Investor enthusiasm for Roche’s obesity franchise may now be on hold, in our view, given that both drugs have shown higher than expected (gastrointestinal) side effects,” Jefferies analysts said in a note on Wednesday, noting that trials have significantly increased the drug’s dosages for patients.
For example, Roche on Wednesday revealed 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 obesity pill helped patients lose up to 7.3% of their body weight in four weeks, compared with 1.2% among those who received a placebo.
This “competitive” weight loss appears to be driven by “rapid” dose increases, which has led to a higher incidence of gastrointestinal side effects, according to the Jefferies analysts. But they note that these side effects can be mitigated by gradually increasing the dose.
“The true competitive profile of the drug will not be clear until data from the larger Phase 2 clinical trials are presented,” the analysts wrote.
JPMorgan analysts were less optimistic in a note Wednesday: “We are concerned about the ability to eliminate high rates” of gastrointestinal side effects, they wrote.
A group of patients who ultimately received the lowest maximum dose of the drug — 90 milligrams — still experienced high rates of nausea “with limited efficacy in weight loss,” the analysts said.
Another group of patients who took the highest maximum dose of the drug — 120 milligrams — with slightly smaller dose increases over time had rates of nausea of 83 percent, vomiting of 33 percent and diarrhea of 50 percent, according to the JPMorgan analysts. They said that tolerability of the drug under this dosing approach “appears to be uncompetitive.”
These 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 experimental obesity pill orforglibon, analysts said.
But Manu Chakravarthy, Roche's head of product development for cardiovascular, renal and metabolic diseases, told CNBC's “Fast Money” on Thursday that the “whole goal” of the study on the pill was to “fail fast” and determine whether there were unexpected safety or efficacy issues.
For this reason, the company has been “moving a little bit faster in the titration scheme than we typically do” in later-stage clinical trials, he said.
He added that the rates of gastrointestinal side effects were “broadly 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 2,” Chakravarthy said, noting that Roche plans to start mid-stage studies in 2025.
Roche doesn’t believe slowing the titration rate will make the company’s shot or pill less effective, he added. That’s because both products showed similar weight loss trajectories, even with slower or lesser dose increases, Chakravarthy said.
“If anything, as we slow down the calibration process, we expect accountability to improve even more,” Chakravarthy told CNBC.
In May, Roche said its CT-388 injection helped obese patients lose 18.8% more weight than those who received a placebo after 24 weeks in a phase 1 trial. The company hopes the drug will eventually demonstrate 25% weight loss in late-stage clinical trials, Chakravarthy told ViralBiotech on Wednesday.
Feel free to send any tips, suggestions, story ideas or data to Annika at annikakim.constantino@nbcuni.com.
The Latest in Healthcare Technology: Oura Enters Metabolic Health Market with Acquisition of Veri
Oura, the smart ring maker, is moving beyond tracking sleep, exercise, and stress into a whole new market: metabolic health.
Ora announced last week that it had agreed to acquire Veri, a company that uses continuous glucose monitoring devices to help users eat healthier and lose weight. Ora did not disclose terms of the deal.
A continuous glucose monitor, or CGM, is a small sensor that is inserted through the skin to track a user’s real-time glucose levels. Glucose is a sugar we get from food and is the body’s main source of energy. Everyone’s glucose levels fluctuate, but consistently high levels can lead to more serious health problems such as metabolic syndrome, insulin resistance, and heart disease.
Continuous glucose monitors have historically been prescribed to people with diabetes, but Abbott and Dexcom have recently launched over-the-counter versions available to any adult who doesn’t take insulin. Both companies offer the sensors for less than $100 a month.
Oura is the latest company looking to assert its position in this emerging market.
Oura CEO Tom Hill wrote in a blog post that the company’s smart ring can already help users track their sleep, heart health, exercise and stress, so expanding into metabolic health was a natural next step. Hill added that about 97% of Oura members said they wanted to understand how their bodies respond to food.
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.
Hill said Ora's acquisition of Veri is just the beginning of the company's plans in the metabolic health market.
“Our ambition is to create an ecosystem of other inputs, such as continuous glucose monitors, that feed into the Oura experience to make it more personalized and actionable,” he added.
As a first step, Oura will introduce a new feature called “Meals” through Oura Labs in the fall, according to a press release. Oura Labs is where users can test new features and provide feedback before they launch more broadly. Meals will allow users to track what they eat to gain insights into how it impacts their sleep, recovery, and stress.
Feel free to send any tips, suggestions, story ideas or data to Ashley at ashley.capoot@nbcuni.com.
