Amgen intends to enter the weight loss drug market with a new approach

takes a new approach trying to stand out in a crowded market of drugmakers racing to develop the next weight loss hit.

A biotechnology company is testing injection treatment that helps people lose weight in a different way than the company’s existing shots and other obesity drugs in development. Amgen’s treatment, called MariTide, also appears to help patients maintain weight after they stop taking it.

The drugmaker can be testing the possibility of taking the drug once a month and even less continuously, which could provide more convenience than weekly medications available on the market.

It’s too early to tell how competitive Amgen might be in the burgeoning weight-loss drug market, which up to now is dominated by Novo Nordisk and Eli Lilly.

Some analysts expect the market might be price it 100 billion dollars by the end of the decade, potentially leaving room for new competitors to enter. Goldman Sachs too projects that by 2028, 10 to 70 million Americans might be taking weight loss drugs.

The available data for Amgen’s injectable drug is promising, but from a small and early stage clinical examination. The Thousand Oaks, California-based company can be developing an oral drug and other treatments for obesity, but revealed few details about them.

Investors and health experts will likely have a higher understanding of Amgen’s prospects later this 12 months: The drugmaker expects to release preliminary data from its mid-stage MariTide trial, along with phase 1 data for its weight-loss pill.

It’s also unclear whether Amgen’s therapies might be cheaper than existing weight-loss drugs, which cost about $1,000 a month.

Novo Nordisk’s Wegovy and Eli Lilly’s Zepbound are leading a new class of obesity treatments which might be attracting continued patient demand – and investor interest – despite their high prices and limited insurance coverage.

Eli Lilly and Novo Nordisk have also struggled to secure enough supply of their drugs, which could give other corporations a probability to gain market share.

The drug Amgen offers a new plot twist on weight loss.

Like Wegovy and Zepbound, one a part of Amgen’s treatment prompts a gut hormone receptor called GLP-1, which helps regulate appetite.

But although Zepbound prompts a second hormone receptor called GIP, Amgen’s drug blocks it. Wegovy doesn’t goal GIP, which suppresses appetite like GLP-1, but may additionally improve the way the body breaks down sugar and fat.

Amgen’s decision to reduce relatively than increase GIP activity is predicated on genetic research suggesting that blocking the receptor is associated with lower fat mass and body weight, company executives say.

This seems to contradict what Zepbound does. Eli Lilly’s approach proved effective: In a late-stage study, the treatment helped obese patients lose up to 22.5% of their body weight after 72 weeks.

However, Amgen’s MartiTide also proved effective in a small, early-stage study.

According to ddata from the first phase of the study was published last month in the journal Nature Metabolism.

There is a broader debate amongst researchers as to why each approaches – blocking and activating GIP – are effective in promoting weight loss.

One theory is that repeatedly activating the GIP receptor, as Zepbound does, ultimately causes the body to regulate itself and make sure that there is not an excessive amount of GIP activity, he said Dr. Caroline Apoviandirector of the Weight Management and Wellness Center at Brigham and Women’s Hospital.

This reduces overall GIP activity, which is assumed to essentially mimic what Amgen does when it blocks the GIP receptor. However, Apovian cautioned that “none of this has been proven” and more data is required.

Early-stage trial data suggests Amgen’s treatment could also be more practical at helping people maintain weight loss than competitors’ products, even when patients take them less continuously.

The Amgen study enrolled 110 patients with obesity but not diabetes. Patients in a single group were randomly assigned to a single dose of the drug and followed for 150 days, while the other group received a dose every 4 weeks for 3 months.

Patients who received a single dose of the highest dose of MariTide lost up to 8.2% of their body weight after 92 days. According to the study authors, this implies that a single injection of the drug produces a prolonged weight loss effect.

In the group that received multiple doses of the drug, patients’ maximum weight loss appeared to be maintained for about two months after the last dose. Then their body weight slowly began to come back. Despite this, their weight was as much as 11.2% less five months after taking the last dose.

“We imagine that significant weight loss is as little as 5%. “If you take Amgen, you lose 14.5%, you stop the drug, and after a few months you still have a loss of 11.2% of your body weight, that’s significant,” she said. Dr. Holly Lofton, director of the New York University Langone Health weight management program and an obesity medicine physician. However, she drew attention to the need to test the treatment on a larger group of individuals.

The sustained weight loss in the Amgen study appears to contrast with the results from clinical trials of Zepbound and Wegovy. Patients in these studies saw their weight return sooner after stopping the injections.

The frequency with which Amgen is used also sets it apart. People taking Wegovy or Zepbound need to take doses every week, compared to once a month with MariTide.

According to the study authors, the Amgen trial used monthly dosing, partially because patients saw sustained weight loss no matter whether or not they received a single injection or multiple injections of the company’s drug.

The authors added that Amgen’s drug may stay in the body for much longer than current treatments resembling Wegovy and Zepbound since it accommodates a monoclonal antibody.

Amgen’s MariTide “has the advantage of being much longer-acting. Even if you give a high dose, you will still have exposure to the drug in your body for a month or two months, which clearly shows that this is not happening “I do not need to take it every week” – William Blair & Company analyst Matt Phipps he told CNBC.

Phipps said people typically don’t want to get shots frequently, so some patients may prefer a monthly shot like Amgen’s MariTide for a disease that’s likely to require long-term treatment.

But he noted that a patient’s choice may also depend on whether Amgen’s level of weight loss and side effects will be comparable to current weekly injections.

Amgen’s ongoing Phase 2 trial is testing whether patients can take the drug even less frequently than once a month.

Amgen’s long-term Phase 2 study of nearly 600 patients will provide greater clarity on how competitive MariTide will be against Wegova and Zepbound. The company is investigating what dose strength and treatment regimen will be best for patients. It expects preliminary trial results to be published later this year.

Some analysts say the phase 2 trial could help answer several questions, including how well patients tolerate treatment with different dosing regimens.

The 52-week study tested 11 different groups of patients at different dosage levels and schedules. This includes starting treatment in some patients with a lower dose and gradually increasing the dose until a higher target dose is reached.

According to Phipps, this dose increase may help reduce the side effects that some patients experienced after taking the first dose of MariTide in the phase 1 study.

In this study, Amgen’s safety and side effects were similar to other GLP-1 drugs. The most commonly reported side effects were nausea and vomiting, which usually lasted for about 72 hours.

The study found that four of eight patients in the highest-dose group withdrew before receiving the second shot because of mild gastrointestinal problems. However, no other patients stopped taking the drug because of side effects in any of the different dosage groups, Amgen’s chief medical officer said Paul Burton he said during a conference earlier this month.

“Based on the first-stage data, it’s a bit early to conclude that the drug is not going to be tolerated by patients,” said Phipps of William Blair & Company.

The next part of Amgen’s Phase 2 trial will also examine weight loss after 52 weeks, which will provide a clearer picture of how long the drug will be effective.