AstraZeneca says experimental obesity pill safe and tolerable in early-stage trial

LONDON, United Kingdom - AstraZeneca said on Monday its experimental weight-loss pill, licensed from China's Eccogene, was safe and tolerable in an early-stage trial, with side effects consistent with the GLP-1 drug class.

The Phase I trial - which had 72 participants - was designed to assess the safety and tolerability of the pill, as is common in the earliest stage of clinical trials. People enrolled in the trial were either healthy, non-obese volunteers or people with type 2 diabetes.

AstraZeneca shares briefly rose as much as 2.9% to a session high after the data release, before paring some gains. At 1530 GMT they were up 0.7%.

The results from the trial gave AstraZeneca confidence to progress the drug into Phase II clinical trials, Sharon Barr, the company's executive vice president of biopharmaceuticals R&D, told a media briefing. She spoke before the data was presented at the ObesityWeek conference in San Antonio, Texas.

One of those trials of the drug, called AZD5004, will focus on reduction in body weight on average in obese and overweight participants and is expected to be completed by the end of 2025, Barr said.

When AstraZeneca announced it had licensed the experimental, once-daily obesity pill from Eccogene a year ago for up to $2 billion, it said it believed the treatment could cause fewer side effects than current injectable treatments such Eli Lilly's Zepbound and Novo Nordisk's Wegovy.

"We saw a dose-dependent increase in nausea and vomiting consistent with molecules in this class," Barr said in the briefing, referring to the drug class of GLP-1 receptor agonists, which slow digestion and reduce hunger. Zepbound and Wegovy are both from this class.

There were no serious adverse events reported from either trial, she said.

AstraZeneca CEO Pascal Soriot acknowledged when the company announced the Eccogene deal in November 2023 that his company was "a few years behind" the roaring success of Novo Nordisk and Eli Lilly who were first to market with highly effective obesity drugs.

But the company is now bullish on the prospects of its obesity business. AstraZeneca's experimental weight-loss pill compares favourably to others in clinical development by rival companies because it is a small molecule that can be combined with other small molecule drugs, said Barr.

"That's very important," she said, adding that more than 60% of obese and overweight people have at least one other medical condition.

Barr also said data from a separate early-stage trial of 14 patients over 28 days showed that the AZD5004 pill can be taken with or without food, with no need for fasting before taking.

U.S. biotech company Viking Therapeutics on Monday released results from an early-stage trial of its own oral obesity treatment that analysts said compared favourably to some rivals in development, leading its shares to climb 9%.

Pfizer and Lilly also have oral weight-loss drugs from the GLP-1 class in later stages of clinical trials. — Reuters