The Amgen logo is displayed outside Amgen headquarters on May 17, 2023 in Thousand Oaks, California.
Mario Tama | Getty Images
Amgen is taking a latest approach because it tries to face out in a crowded field of drugmakers racing to develop the following blockbuster weight reduction drug.
The biotech company is testing an injectable treatment that helps people shed some pounds in another way from the present injections from Novo Nordisk and Eli Lilly, and other obesity medicines in development. Amgen’s treatment, called MariTide, also appears to assist patients keep weight off after they stop taking it.
The drugmaker can be testing its drug to be taken once a month and even less incessantly, which could offer more convenience than the weekly medicines in the marketplace.
It’s too early to say how competitive Amgen will probably be within the budding weight reduction drug space, which Novo Nordisk and Eli Lilly have up to now dominated.
Some analysts expect the market may very well be price $100 billion by the tip of the last decade, potentially leaving room for brand spanking new competitors to enter. Goldman Sachs also projects that between 10 million and 70 million Americans will probably be taking weight reduction 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 greater idea of Amgen’s prospects later this 12 months: The drugmaker expects to release initial data from an ongoing mid-stage trial on MariTide, together with phase one data on its obesity pill.
It is also unclear whether Amgen’s treatments will probably be cheaper than the present weight reduction drugs, which cost around $1,000 per 30 days.
Wegovy from Novo Nordisk and Zepbound from Eli Lilly lead a latest 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 supply enough supply of their treatments, which could give other firms a likelihood to win market share.
How Amgen’s treatment is different
Amgen’s drug offers a latest twist on weight reduction.
Very like Wegovy and Zepbound, one a part of Amgen’s treatment prompts a gut hormone receptor called GLP-1 to assist regulate an individual’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 might also improve how the body breaks down sugar and fat.
Amgen’s decision to tamp down fairly 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 reduction 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 as much as 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, in keeping with data from the phase one trial published last month within the journal Nature Metabolism.
There is a broader debate amongst researchers about why each approaches – blocking and activating GIP – are effective at promoting weight reduction.
One theory is that repeatedly activating the GIP receptor, as Zepbound does, ultimately causes the body to “self-regulate” itself and be certain 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 lead to longer-lasting weight reduction
Amgen’s treatment could also be higher at helping people maintain weight reduction than competitors, despite the fact that patients take it less incessantly, 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 reduction medication.
Joe Buglewicz | The Washington Post | Getty Images
Patients who received a single shot of the best dose of MariTide lost as much as 8.2% of their body weight after 92 days. That means a single injection of the drug has a chronic weight reduction effect, in keeping with the study authors.
Within the group that received multiple doses of the drug, patients appeared to take care of their maximum weight reduction 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 reduction is already 5%. In case you take Amgen’s drug, lose 14.5%, stop the drug and still have 11.2% weight reduction after a number of 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 bigger group of individuals.
The sustained weight reduction 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 should take doses weekly, compared with the once-monthly MariTide.
Amgen’s trial used monthly dosing partly because patients saw sustained weight reduction whether or not they had a single injection or multiple shots of the corporate’s drug, in keeping with 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 features a monoclonal antibody, the authors added.
An injection pen of Zepbound, Eli Lilly’s weight reduction drug, is displayed in Latest York City, U.S., December 11, 2023.
Brendan McDermid | Reuters
Amgen’s MariTide “has that advantage where it’s just going to last lots longer. Even in case 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 needn’t take it every week,” William Blair & Company analyst Matt Phipps told CNBC.
Phipps said people typically don’t desire to get injections often, so some patients could prefer a monthly shot like Amgen’s MariTide for a disease that may likely require chronic treatment.
But he noted that a patient’s alternative might also depend upon whether the extent of weight reduction and uncomfortable side 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 incessantly 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 will probably 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 12 months.
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 wide range of dosing levels and regimens. That features starting some patients at a lower dose of a drug and progressively increasing it until they reach a better goal dose.
That dose escalation could help reduce uncomfortable side effects that some patients experienced after taking their first dose of MariTide within the phase one trial, in keeping with Phipps.
In that trial, the protection and uncomfortable side effects of Amgen’s drug were just like other GLP-1 medications. Nausea and vomiting were essentially the most commonly reported uncomfortable side effects, and typically lasted for about 72 hours.
4 out of eight patients in a gaggle receiving the best dose of the treatment withdrew before getting a second shot as a consequence of mild gastrointestinal issues, in keeping with the study. But no other patients stopped taking the drug as a consequence of hostile events across any of the several dosing groups, Amgen Chief Medical Officer Paul Burton said during a conference earlier this month.
“It’s somewhat early to leap 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 may even examine weight reduction beyond 52 weeks, which can provide a clearer picture of how long the drug is effective.