The Amgen logo is displayed outside Amgen headquarters on May 17, 2023 in Thousand Oaks, California.
Mario Tama | Getty Images
Amgen is taking a new approach because it tries to stand out in a crowded field of drugmakers racing to develop the following blockbuster weight loss drug.
The biotech company is testing an injectable treatment that helps people lose weight otherwise from the present injections from Novo Nordisk and Eli Lilly, and other obesity medicines in development. Amgen’s treatment, called MariTide, also appears to help patients keep weight off after they stop taking it.
The drugmaker can also be testing its drug to be taken once a month and even less ceaselessly, which could offer more convenience than the weekly medicines on the market.
It’s too early to say how competitive Amgen might be within the budding weight loss drug space, which Novo Nordisk and Eli Lilly have to this point dominated.
Some analysts expect the market could possibly be value $100 billion by the tip of the last decade, potentially leaving room for new competitors to enter. Goldman Sachs also projects that between 10 million and 70 million Americans might be taking weight loss drugs by 2028.
The available data on Amgen’s injectable drug is promising, but it surely’s from a small, early-stage clinical trial. The Thousand Oaks, California-based company is also developing an oral medicine and other treatments for obesity, but has disclosed few details about them.
Investors and health experts will likely get a higher idea of Amgen’s prospects later this yr: The drugmaker expects to release initial data from an ongoing mid-stage trial on MariTide, along with phase one data on its obesity pill.
It is also unclear whether Amgen’s treatments might be cheaper than the present weight loss drugs, which cost around $1,000 monthly.
Wegovy from Novo Nordisk and Zepbound from Eli Lilly lead a new class of obesity treatments that has drawn unrelenting patient demand — and investor interest — despite their hefty price tags and limited insurance coverage.
Eli Lilly and Novo Nordisk have also struggled to offer enough supply of their treatments, which could give other corporations a probability to win market share.
How Amgen’s treatment is different
Amgen’s drug offers a new twist on weight loss.
Very similar to Wegovy and Zepbound, one a part of Amgen’s treatment prompts a gut hormone receptor called GLP-1 to help regulate a person’s appetite.
But while 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 how the body breaks down sugar and fat.
Amgen’s decision to tamp down somewhat than boost GIP activity is predicated on genetics research suggesting that blocking the receptor is linked to lower fat mass and body weight, company executives have said.
Some approved and experimental weight loss drugs
- Wegovy from Novo Nordisk: Approved weekly injection that prompts GLP-1
- Zepbound from Eli Lilly: Approved weekly injection that prompts GLP-1 and GIP
- Saxenda from Novo Nordisk: Approved weekly injection that prompts GLP-1
- MariTide from Amgen: Experimental monthly injection that prompts GLP-1 and blocks GIP
- Danuglipron from Pfizer: Experimental once-daily pill that prompts GLP-1
- VK2735 from Viking Therapeutics: Experimental weekly injection that prompts GLP-1 and GIP
- Pemvidutide from Altimmune: Experimental weekly injection that prompts GLP-1 and one other gut hormone called glucagon
- GSBR-1290 from Structure Therapeutics: Experimental weekly pill that prompts GLP-1
- Survodutide from Zealand Pharma, Boehringer Ingelheim: Experimental weekly injection that prompts GLP-1 and glucagon
That appears to contradict 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 trial.
But Amgen’s MartiTide also was effective in a small, early-stage study.
Patients given the best dose of Amgen’s drug — 420 milligrams — every month lost 14.5% of their body weight on average in only 12 weeks, according to data from the phase one trial published last month within the journal Nature Metabolism.
There’s a broader debate amongst researchers about why each approaches – blocking and activating GIP – are effective at promoting weight loss.
One theory is that repeatedly activating the GIP receptor, as Zepbound does, ultimately causes the body to “self-regulate” itself and ensure that there is not an excessive amount of GIP activity, said Dr. Caroline Apovian, a director of the Center for Weight Management and Wellness at Brigham and Women’s Hospital.
That decreases GIP activity overall, which is believed to essentially mimic what Amgen’s drug achieves when it blocks the GIP receptor. But Apovian cautioned that “none of that is proven” and more data is required.
The drug could end in longer-lasting weight loss
Amgen’s treatment could also be higher at helping people maintain weight loss than competitors, regardless that patients take it less ceaselessly, early-stage trial data suggests.
Amgen’s study enrolled 110 patients with obesity but not diabetes. Patients in a single group were randomly assigned to receive a single dose of the drug and were followed for 150 days, while a second group was given a dose every 4 weeks for 3 months.
An obesity patient takes a injection of weight loss medication.
Joe Buglewicz | The Washington Post | Getty Images
Patients who received a single shot of the best dose of MariTide lost up to 8.2% of their body weight after 92 days. That implies a single injection of the drug has a prolonged weight loss effect, according to the study authors.
Within the group that received multiple doses of the drug, patients appeared to maintain their maximum weight loss until around two months after their last dose. Their body weight began to slowly return after that. Still, their weight was as much as 11.2% lower five months after they received the last dose.
“We expect meaningful weight loss is already 5%. Should you take Amgen’s drug, lose 14.5%, stop the drug and still have 11.2% weight loss after a few months, that is significant,” said Dr. Holly Lofton, director of the Weight Management Program at NYU Langone Health and an obesity medicine physician. But she identified the necessity to study the treatment in a larger group of individuals.
The sustained weight loss in Amgen’s study appears to contrast with results seen in clinical trials on Zepbound and Wegovy. Patients in those studies saw their weight rebound sooner after stopping the injections.
Once a month and even less frequent dosing
The frequency of Amgen’s drug also sets it apart. Those on Wegovy or Zepbound have to take doses weekly, compared with the once-monthly MariTide.
Amgen’s trial used monthly dosing partly because patients saw sustained weight loss whether or not they had a single injection or multiple shots of the corporate’s drug, according to the study authors.
Amgen’s treatment can also stay within the body for for much longer than current therapies like Wegovy and Zepbound since it includes a monoclonal antibody, the authors added.
An injection pen of Zepbound, Eli Lilly’s weight loss drug, is displayed in New York City, U.S., December 11, 2023.
Brendan McDermid | Reuters
Amgen’s MariTide “has that advantage where it’s just going to last a lot longer. Even in the event you give a high dose, you are still going to have drug exposure within the body for a month or two months, in order that clearly shows you do not need to take it every week,” William Blair & Company analyst Matt Phipps told CNBC.
Phipps said people typically don’t need to get injections often, so some patients could prefer a monthly shot like Amgen’s MariTide for a disease that can likely require chronic treatment.
But he noted that a patient’s alternative may additionally depend upon whether the extent of weight loss and unwanted effects of Amgen’s drug find yourself being on par with those of the present weekly injections.
Amgen’s ongoing phase two trial is exploring whether patients can take its drug even less ceaselessly than once a month.
Phase two trial will bring more clarity
Amgen’s longer-term phase two study on nearly 600 patients will provide more clarity on how competitive MariTide might be against Wegovy and Zepbound. The corporate is exploring which dose strength and schedule is best for patients. It expects to release initial trial results later this yr.
Some analysts have said the phase two trial could help address several questions, including how well patients tolerate the treatment at different dose regimens.
The 52-week study is testing 11 different patient groups at a number of dosing levels and regimens. That features starting some patients at a lower dose of a drug and regularly increasing it until they reach a higher goal dose.
That dose escalation could help reduce unwanted effects that some patients experienced after taking their first dose of MariTide within the phase one trial, according to Phipps.
In that trial, the protection and unwanted effects of Amgen’s drug were similar to other GLP-1 medications. Nausea and vomiting were probably the most commonly reported unwanted effects, and typically lasted for about 72 hours.
4 out of eight patients in a group receiving the best dose of the treatment withdrew before getting a second shot due to mild gastrointestinal issues, according to the study. But no other patients stopped taking the drug due to hostile events across any of the several dosing groups, Amgen Chief Medical Officer Paul Burton said during a conference earlier this month.
“It’s a little early to jump to the conclusion that the drug won’t be tolerated by patients based on this phase one data,” William Blair & Company’s Phipps said.
One other a part of Amgen’s phase two trial can even examine weight loss beyond 52 weeks, which is able to provide a clearer picture of how long the drug is effective.