The Zhitong Finance App learned that upcoming data from the mid-term study of the AMGN.US (AMGN.US) experimental weight loss drug MariTide will reveal the comparison between this drug and GLP-1 drugs sold by LLY.US (LLY.US) and Novo Nordisk (NVO.US). Mizuhu analyst Salim Syed said in a recent report: “We think this stock is a double-edged sword and is highly dependent on Maritide data at the end of 2024.”

Amgen's positive evaluation of the 52-week phase 2 clinical trial boosted the company's stock price by 8% over the past year. This rally lost momentum in recent weeks as investors sought more information on the safety of this injectable drug.

Amgen said that compared to weekly GLP-1 such as Novo Novo's WegoVy and Eli Lilly's Zepbound, the drug can reduce weight faster, has better weight maintenance effects, and is injected less frequently. Chief Scientific Officer Jay Bradner said in a recent conference call: “MariTide is likely to be the first monthly or even lower frequency treatment in this case.”

Wall Street analysts expect multi-dose trials to show at least 20% weight loss and emphasize the need to detail potential side effects, including nausea, bone density issues, heart rate, and blood sugar.

Wegovy was approved to treat obesity in 2021 after research showed that Wegovy lost 68% of weight in 15 weeks, and Zepbound data showed a weight loss of over 22% in 72 weeks.

Matt Phipps (Matt Phipps), an analyst at William Blair & Co, said: “For MariTide, achieving a weight loss of 20% or more is the minimum standard, but many investors want to lose weight close to 25%.” He said the tests needed to prove that weight loss was dose-related.

Amgen plans to announce the results of the phase 2 trial before the end of the year, and has outlined the phase 3 trial plan required to submit the drug to regulators for approval.

MariTide may eventually enter the diet medicine market, which is estimated by some analysts to exceed $150 billion a year. A small phase 1 trial showed that patients receiving the highest dose of the test lost 16% of their body weight after receiving monthly injections for three months.

However, Morningstar analyst Karen Anderson (Karen Anderson) said the drug was linked to nausea and vomiting, “causing half of patients to withdraw from the trial.”

“The second phase gave Amgen an opportunity to refine dosage sizes and the speed at which patients increased doses to minimize weight loss and reduce side effects,” she said. “I expect a significant weight loss, probably much higher than the 18 percent Eli Lilly Zepbound we saw at 48 weeks.”

Phipps said that if Amgen did not provide information on the rate and severity of nausea, “it would be viewed as negative.” Wegovy causes nausea in more than 40% of patients, compared to about 25% of Zepbound.

A different approach

WegoVy is a drug that acts on receptors for the hormone GLP-1 (glucagon-like peptide-1), which regulates appetite and lowers blood sugar. Zepbound, on the other hand, stimulates GLP-1 and another gut hormone called GIP (gastric inhibitory peptide).

Amgen has taken a different approach. MariTide is an antibody that connects to a pair of peptide chains. This structure can activate GLP-1 receptors while blocking GIP receptors.

On Wednesday, Amgen's stock price closed at $287.87, down about 9% from earlier this month. At the time, analysts at Cantor Fitzgerald said their evaluation of the first phase MariTide data showed a declining trend in bone density, which could increase the risk of fractures.

Some studies suggest that GIP helps bone formation, so as the Cantor report points out, Amgen's strategy to suppress this hormone theoretically raises concerns about bone loss.

Amgen issued a statement saying, “We have not seen a link between taking MariTide and changes in bone density.” The company previously explained that MariTide was developed based on genetic data, which showed that suppressing GIP could prevent obesity.

Jefferies analyst Michael Yee said Amgen's stock price could rise 20% if the phase 2 trial showed weight loss of 23% to 25% or more, patient withdrawal rates of less than 10%, and included quarterly dosing.

At the end of October, he said that if the weight loss is less than 20%, and the drug withdrawal rate exceeds 15% due to safety issues or high nausea and vomiting rates, then the stock price may drop 20%.