ECC-5004

At Viking's ObesityWeek conference on Sunday, data from a study got a lot of attention. The early study, which included 92 participants, showed that those who took a 100 mg dose of Viking tablets lost an average of 6.8 percent of their body weight in just 28 days. This result not only exceeded expectations, but also exceeded the results of competing experimental treatments. In contrast, those taking a placebo lost an average of 1.4 percent of their body weight. Bloomberg analyst Michael Shah further noted in a note that the pill was well tolerated, with few side effects and only mild nausea, and patients did not need to stop taking it. These positive study results indicate that Viking is on track to enter mid-stage trials in the fourth quarter. Meanwhile, Astrazeneca also presented its findings at the ObesityWeek conference on Monday, November 4. In an earlier study of 72 people, it was found that patients lost an average of 5.8 percent of their body weight after taking the pill orally and following four weeks of treatment. The oral pill, called AZD5004, mimics a gut hormone called GLP-1 to effectively control blood sugar and suppress appetite. The trial showed no serious side effects in patients with doses up to 50 mg. Viking shares have risen more than 290% so far this year, largely due to high investor hopes for an oral weight loss drug the company is developing. In addition, Viking's new tablets are considered to have significant market potential, which could attract acquisition interest from large pharmaceutical companies. William Blair analyst Andy Hsieh said: "Viking's diet drugs are working better than everyone expected, which increases the likelihood of a big Pharma acquisition of Viking. While we acknowledge that it is risky to base investment decisions on the prospect of future acquisitions, the likelihood is considerable." Analysts point out that the launch of Viking and Astrazeneca's oral pills has intensified competition in the diet drug market between large pharmaceutical companies and small biotech companies. As drug companies scramble to come up with weight-loss pills that appeal to more people, they are all vying for a piece of a huge market that is expected to reach $130 billion by the end of the century.

While AstraZeneca didn't unveil any splashy data at this year's ObesityWeek conference, it projected confidence in its trio of weight-loss hopefuls during its presentation on Monday, though that boldness may soon be tested, as obesity programmes — which have driven some of the year's biggest valuation climbs — have, of late, fallen under increased investor scrutiny.The UK pharma disclosed that it will advance oral GLP-1 agonist AZD5004 — licensed almost exactly a year ago from Eccogene in a deal worth about $2 billion in biobucks — into a pair of Phase IIb trials, justified by "encouraging data" from its Phase I study."This is AstraZeneca, and we played a win. If we didn't think we had a highly competitive molecule we would not be further investing in that molecule and moving it forward rapidly through clinical development," commented Sharon Barr, executive vice president of biopharmaceuticals R&D at AstraZeneca.The drugmaker traded flat for the day in London. While whispers of weight-loss success were once able to drive double-digit pharma moves earlier in the year (looking at you, Amgen), that no longer appears to be the case as analysts raise the bar on what will be obesity's 'next big thing,' as well as the current market leaders.Both incretin front-runners Eli Lilly and Novo Nordisk have seen their shares buckle under high expectations. The former fell 6% last week after posting disappointing third-quarter sales for Mounjaro/Zepbound (tirzepatide), and it's possible the latter will see similar downward movement this week when it shares its own earnings report, given Ozempic/Wegovy (semaglutide) had missed estimates for the second quarter (see – Vital Signs: Eli Lilly attempts to drum up demand for GLP-1s and Vital Signs: Novo’s US pricing struggles).Clinical programmes are also feeling the pressure. Novo Nordisk took a hit of more than $25 billion to its market cap in September when it reported somewhat mediocre data for a mid-stage candidate. That same month, investors shaved a few billion dollars off of Roche's valuation on the news that its oral incretin agonist left something to be desired in terms of gastrointestinal tolerability (see – Vital Signs: Novo Nordisk rout raises expectations for Amgen). Meanwhile on Monday, Viking Therapeutics suffered a $1-billion dent to its market cap after seemingly positive data for its oral GLP-1/GIP agonist failed to overcome production capacity concerns. Advancing assets AstraZeneca's ObesityWeek presentation was scant on details, but featured positive forward momentum for each of its weight-loss assets. In addition to AZD5004, the pharma is developing AZD6234, a long-acting amylin analogue with once-weekly subcutaneous dosing, and AZD9550, an injectable GLP-1/glucagon agonist.The drugmaker reported that AZD5004, a once-daily oral small molecule, had an "encouraging safety profile at a range of doses" as well as "promising potency" in Phase I testing, with average weight loss of 5.8% over four weeks. There was a "dose dependent increase in nausea and vomiting consistent with molecules in this class," noted Sharon Barr, executive vice-president of biopharmaceuticals R&D, although no patients discontinued treatment due to these side effects, with higher doses of the drug set to be tested,The results prompted AstraZeneca to launch the Phase IIb VISTA trial in patients with overweight and obesity, and the Phase IIb SOLSTICE study for type 2 diabetes. The former is expected to enrol 304 participants and wrap up by the end of next year, and the later is projected to recruit 384 patients and finish in early 2026. The company also revealed it has already kicked off the Phase IIb APRICUS study of AZD6234 in individuals with obesity or overweight that's expected to conclude in 2026. In Phase I testing, the candidate had a favourable tolerability profile with no safety concerns, as well as "encouraging weight loss after a single dose."AstraZeneca is in the planning stages for yet another Phase IIb trial, but this one will combine AZD6234 with AZD9550 to achieve a "triple mechanism" effect that it hopes will lead to higher quality, fat mass-specific weight loss with end-organ protection. The company didn't provide a timeline for the upcoming study, but shared that "encouraging Phase I data provided confidence for the combination strategy."Other combinations also appear to be in the works. The pharma told FirstWord that "due to the complexity of interconnected obesity and cardiometabolic disease, we are uniquely positioned to deliver this through mono and combination therapies, given the breadth of our portfolio."