Roche data reveals the stomach-churning effects of weight loss drugs

Roche has raised hopes that the Swiss pharmaceutical company may have a blockbuster drug in its hands. Early trial results showed rapid weight loss for recipients of new treatments from the Swiss group. Investors have been unnerved by the recent revelations that high rates of vomiting, and other side effects, among people who take strong doses of these drugs has brought to light the difficulties facing companies looking to enter this lucrative new market.

Shares in the company fell by 4 percent on Monday, after the company revealed that 75 percent of patients who received its CT-388 injection at their highest dosage suffered vomiting. The shares fell again by 5 percent on Thursday, after the same data was released for its weight-loss pills.This reaction reminds us that not everyone can tolerate the new weight-loss treatment class dominated by Novo Nordisk, and Eli Lilly. And that those who challenge the industry pioneers will face many obstacles.

The treatment was one of the main topics of discussion at the European Association for the Study of Diabetes conference in Madrid, this week.Peter Verdult said that Roche caused itself problems by referring to its July trial results as “really unique data”.He said, “I don’t think anyone could say that today.” “They set themselves for a fall.”

The global drug industry is racing to catch up to Novo Nordisk’s and Eli Lilly’s leadership in the lucrative, rapidly growing GLP-1 market.GLP-1 drugs were present in almost 10% of the 1,150 abstracts that were presented at the Madrid Conference.Goldman Sachs analysts estimate that the market for these products could reach $130bn per year by 2030.

These drugs mimic the gut hormone GLP-1 which reduces blood sugar levels and curbs appetite. Eli Lilly’s Mounjaro, for example, also contains GIP, another gut hormone that seems to boost weight loss. Companies are also experimenting with pancreatic and gut hormones.

Francine Kaufman is the former chief of the American Diabetes Association, and the current chief medical officer at medical device company Senseonics. She said that the drugs revolutionized diabetes care during a time when obesity rates are on the rise.

She said, “I told you in the 2000s we needed a magic bullet.” “It arrived.”

GLP-1-based medications are associated with nausea, vomiting and constipation – especially at higher doses. In some studies, they have also been linked to muscle loss. Both the US Food and Drug Administration and European Medicines Agency investigated other serious side effects reported with recent medications — such as suicidal feelings — but found that there was no link.

Manu Chakravarthy who heads the metabolic product development at Roche defended the potential of the company’s drugs. He said that the company had wanted to “push” the tolerability of its drug, and that side effects were similar to other GLP-1 based drugs.

Chakravarthy said that users of Roche’s product in future trials are unlikely to receive such rapid or high doses.He said, “We are encouraged because it can’t get worse than this.”Early trials are often used by drugmakers to test safety and high doses. Verdult stated that there were concerns about side effects years ago, when Novo Nordisk presented data on its drugs.Novo Nordisk, at the Madrid conference presented data about a new drug – oral amycretin – which caused vomiting in over half of the users who took the highest dose.

Some patients are put off by the side effects. Blue Health Intelligence published a study this year that found 30 percent of GLP-1 users quit treatment within four weeks. Side effects were cited as a major factor. The cost and availability of drugs is also a factor.

In a column in the Daily Mail last year, Boris Johnson revealed that he could not tolerate the vomiting he experienced after taking Ozempic for diabetes off-label.

Some drug manufacturers have experienced setbacks when developing small molecule pills, which are synthetic drugs easier to produce at large scale than weight loss injections.Pfizer has abandoned its twice-daily weight loss drug danuglipron due to high levels of nausea and vomiting during mid-stage clinical trials. The New York-based pharmaceutical company is pushing forward with a daily version that has been tweaked.

Companies are creating alternative drug formulations to combat side effects. Analysts have noted the excitement over amylin. This pancreatic hormone is believed to reduce muscle loss linked to drugs. However, this has not yet been proven at scale.

CagriSema, the next product from Novo Nordisk, combines GLP-1s and an analog of amylin. The drugmaker plans to report data from late-stage testing of the product later this year.

Eli Lilly struck several deals to address the problem of muscle loss. It spent $1.9bn last year to acquire Versanis. The lead drug of Versanis is based upon the hormone activin, which helps regulate muscle mass. It has also formed a partnership with BioAge, which is developing a drug for muscle regeneration. BioAge filed for an initial public offer recently.

The new data shows how much more companies, scientists and investors still need to learn about GLP-1 treatments.One of the studies presented at Madrid showed that Eli Lilly’s Mounjaro led to greater weight loss in women than men, but caused more nausea and vomiting.Luis-Emilio Garcia-Perez said that the Eli Lilly scientist, who conducted the study, did not know the reason for the differences in results between the two groups.

Ilya Yufa, Eli Lilly’s head of International Operations, said that it was unclear whether the new treatments will have fewer side-effects and allow for the anticipated wide take-up.

“For other molecules in development, which may have a new approach, I think that it’s probably still too early to know what they look like across a broader population,” said Yuffa.