Health

Amgen wants to enter the booming market for weight loss drugs – and is taking a different approach

The Amgen logo is displayed in front of the Amgen headquarters in Thousand Oaks, California on May 17, 2023.

Mario Tama | Getty Images

Amgen is taking a new approach, trying to stand out from the crowded field of drugmakers racing to develop the next blockbuster weight-loss drug.

The biotech company is testing an injectable treatment that helps people lose weight in a different way than previous injections Novo Nordisk And Eli Lillyand other anti-obesity drugs in development. Amgen’s treatment, called MariTide, also appears to help patients reduce their weight after they stop taking it.

The drugmaker is also testing that its drug should be taken once a month or even less often, which could provide more convenience than weekly medications on the market.

It’s too early to tell how competitive Amgen will be in the emerging weight-loss drug market that Novo Nordisk and Eli Lilly have dominated so far. Some analysts believe the market could have value 100 billion dollars by the end of the decade, potentially leaving room for new competitors to enter. Also Goldman Sachs Projects that by 2028, between 10 and 70 million Americans will be taking weight loss medications.

The available data on Amgen’s injectable drug is promising, but comes from a small, early-stage trial. The Thousand Oaks, Calif.-based company is also developing an oral drug and other treatments against obesity, but has revealed few details about it.

Investors and health experts will likely get a better idea of ​​Amgen’s prospects later this year: The drugmaker expects to release early data from an ongoing mid-stage study of MariTide as well as Phase 1 data on its obesity pill.

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

Novo Nordisk’s Wegovy and Eli Lilly’s Zepbound lead a new class of obesity treatments that have attracted continued patient demand – and investor interest – despite their high prices and limited insurance coverage.

Eli Lilly and Novo Nordisk have also struggled to offer a sufficient range of treatments, which could give other companies a chance to gain market share.

How different the treatment is at Amgen

Amgen’s drug offers a new approach to weight loss.

Similar to Wegovy and Zepbound, part of Amgen’s treatment activates a gut hormone receptor called GLP-1 to regulate a person’s appetite.

But while Zepbound triggers a second hormone receptor called GIP, Amgen’s drug blocks it. Wegovy does not target GIP, which, like GLP-1, suppresses appetite but can also improve the way the body breaks down sugar and fat.

Amgen’s decision to lower GIP rather than increase it is based on genetic research that suggests blocking the receptor could help patients lose more body weight, company executives said.

Approved and experimental weight loss medications

  • Wegovy from Novo Nordisk: Approved weekly injection that activates GLP-1
  • Zepbound by Eli Lilly: Approved weekly injection that activates GLP-1 and GIP
  • Saxenda from Novo Nordisk: Approved weekly injection that activates GLP-1
  • MariTide from Amgen: Experimental monthly injection that activates GLP-1 and blocks GIP
  • Danuglipron from Pfizer: Experimental Once-daily pill that activates GLP-1
  • Viking Therapeutics VK2735: Experimental weekly injection that activates GLP-1 and GIP
  • Pemvidutide from Altimmune: Experimental weekly injection that activates GLP-1 and another gut hormone called glucagon
  • GSBR-1290 from Structure Therapeutics: Experimental weekly pill that activates GLP-1
  • Survodutide from Zealand Pharma, Boehringer Ingelheim: Experimental weekly injection that activates GLP-1 and glucagon

This seems contradictory to how Zepbound works. Eli Lilly’s approach has proven successful: The treatment helped patients with obesity lose up to 22.5% of their weight after 72 weeks in a late-stage study.

But MartiTide from Amgen also proved effective in a small, early study.

According to the phase 1 study published last month in the journal Nature Metabolism, patients given the highest dose of the Amgen drug each month – 420 milligrams – lost an average of 14.5% of their body weight in just 12 weeks.

The drug could lead to longer-lasting weight loss

Amgen treatment may be better at helping people maintain weight loss than competitors, even if patients take it less frequently, early trial data shows.

Amgen’s study included 110 patients who were obese but not diabetic. Patients in one group were randomly assigned to receive a single dose of the drug and followed for 150 days, while a second group was given a dose every four weeks for three months.

An obesity patient takes an injection of a weight loss medication.

Joe Buglewicz | The Washington Post | Getty Images

Patients who received a single injection of the highest dose of MariTide lost up to 8.2% of their body weight after 92 days. That suggests that a single injection of the drug has a longer-lasting weight loss effect, the study authors said.

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. Afterwards, her body weight slowly began to increase again. However, five months after receiving the last dose, their weight was up to 11.2% lower.

“We believe that meaningful weight loss is as low as 5%. If you take Amgen’s drug, lose 14.5%, stop taking the drug, and after a few months you still have an 11.2% weight loss, that’s significant,” said Dr. Holly Lofton, director of the weight management program at NYU Langone Health and an obesity medicine physician. However, she pointed to the need to study the treatment in a larger group of people.

The sustained weight loss in Amgen’s study appears to contrast with clinical trial results for Zepbound and Wegovy. Patients in these studies gained weight more quickly after stopping injections.

Once a month or even less often

The frequency of Amgen’s drug also sets it apart. Those taking Wegovy or Zepbound must take doses weekly, compared to once a month with MariTide.

According to the study authors, Amgen’s study used monthly dosing in part because patients saw sustained weight loss regardless of whether they received a single injection or multiple injections of the company’s drug.

Amgen’s treatment can also last much longer in the body than current therapies such as Wegovy and Zepbound because it contains a monoclonal antibody, the authors added.

An injection pen of Zepbound, Eli Lilly’s weight loss drug, is displayed on December 11, 2023 in New York City, United States.

Brendan McDermid | Reuters

Amgen’s MariTide “has the advantage that it simply lasts much longer. Even if you give a high dose, your body will still be exposed to the drug for a month or two, which clearly shows that you don’t need to take it every week,” said Matt Phipps, an analyst at William Blair & Company, told CNBC.

Phipps said people typically don’t want to receive frequent injections, so some patients might prefer a monthly shot like Amgen’s MariTide for a disease that’s likely to require chronic treatment.

However, he noted that a patient’s choice may also depend on whether the extent of weight loss and side effects of the Amgen drug end up being comparable to those of existing weekly injections.

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

The phase 2 study will provide more clarity

Amgen’s longer-term Phase 2 trial of nearly 600 patients will provide more clarity on how competitive MariTide will be versus Wegovy and Zepbound. The company is studying what dose and schedule is best for patients. The first test results are expected to be published this year.

Some analysts said the Phase 2 trial could help answer several questions, including how well patients tolerate the treatment.

The 52-week study will test 11 different patient groups with different dosages and treatment regimens. This involves some patients starting on a lower dose of a drug and gradually increasing it until they reach a higher target dose.

This dose increase could help reduce side effects that some patients experienced after taking their first dose of MariTide in the Phase 1 trial, according to Phipps.

In this study, the safety and side effects of Amgen’s drug were similar to those of other GLP-1 drugs. Nausea and vomiting were the most commonly reported side effects and typically lasted about 72 hours.

According to the study, four of eight patients in a group who received the highest dose of treatment discontinued treatment due to mild gastrointestinal problems before receiving a second vaccination. But no other patients stopped taking the drug because of adverse events in any of the different dosage groups, Paul Burton, Amgen’s chief medical officer, said during a conference earlier this month.

“Based on these Phase 1 data, it is a little early to jump to conclusions that the drug is not tolerated by patients,” Phipps said.

Another part of Amgen’s Phase 2 trial will also examine weight loss beyond week 52, which will provide a clearer picture of how long the drug is effective.

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