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.
