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Good news for those averse to injections: GLP-1 agonist medication is a step closer to being offered in oral pill form, with AstraZeneca unveiling “encouraging data” from its Phase I trial of its obesity and diabetes drug AZD5004.
In a presentation at the Obesity Week At its conference in San Antonio this week, the British pharmaceutical company perhaps best known lately for its COVID-19 vaccine said AZD5004 performed similarly to injected GLP-1 agonists in the early phase of the trial , and is now being assessed in two Phase IIb studies. studies, the results of which are not expected until the end of 2025.
Like current injectable drugs, the oral GLP-1 agonist is AstraZeneca’s big hope to enter the lucrative anti-obesity drug market and join companies like Novo Nordisk, the Danish company behind the semaglutide products. Ozempic for diabetes and Wegovy for obesity.
In the phase I study, in which AZD5004 was tested on 72 healthy, non-obese patients or people with type 2 diabetes, the drug was considered safe in doses under 50 mg. Higher doses caused an increase in adverse gastrointestinal problems – in line with the side effects most commonly reported with the drugs currently on the market. The people in the trial had an average weight loss of 5.8% after four weeks and saw improvements in their fasting plasma glucose.
Now the drug will enter a dedicated Phase IIb study in obesity (the Vista study), as well as one specifically for type 2 diabetes (the Solstice study), which will undoubtedly, like Novo Nordisk, hopefully include two specific GLP-1 agonists will emerge. medications. The obesity study is expected to enroll 304 people and be completed by the end of 2025. The Solstice trial, involving 384 patients, is expected to continue until early 2026.
AstraZeneca licensed the AZD5004 from Chinese company Eccogene for almost $2 million in 2023, but expects that if all goes according to plan in the next phase, it will achieve sales of $800 million by 2032.
“We believe this oral GLP-1RA molecule could provide alternatives to current injectable therapies, both as a potential monotherapy and in combination for cardiometabolic diseases such as type 2 diabetes, as well as for obesity,” said Executive Vice President Sharon Barr. said last year when the Eccogene deal was closed.
Although the company’s presentation at the conference was short on details, it revealed that AZD5004 would be a small-molecule drug to be administered once a day. It also revealed plans for another trial combining this drug with AZD6234, a long-acting analogue that targets the pancreatic hormone amylin, which is currently in a Phase IIb weight loss trial. The company hopes that a combination of the two will result in more targeted and effective fat loss.
At the conference, Barr did not reveal a timeline for this two-drug trial, but said that “encouraging Phase I data provided confidence for the combination strategy.”
Tested for safety and tolerability, AZD5004 – taken with and without food – reportedly resulted in no serious side effects.
“We saw a dose-dependent increase in nausea and vomiting, consistent with molecules in this class,” Barr said at a briefing.
AstraZeneca is a few years behind Novo Nordisk and Eli Lilly, but demand for its obesity drugs suggests there is plenty of room in the market for more players – especially in oral medications.
Viking Therapeutics also presented early phase results from its own trial candidate for oral obesity. The company reported that its dual GLP-1/GIP co-agonist VK2735 led to an average weight loss of 8.2% over 28 days at the highest dose tested of 100 mg.
Sources: AstraZeneca, Obesity Week, Viking therapies