Amycretin

Pills that work similarly to currently available injectable medications represent the next wave of metabolic disorder drugs, and Viking Therapeutics is pushing its drug candidate to the forefront with early clinical data that have some analysts calling it potentially best in the class of emerging oral obesity drugs. In a small Phase 1 study, Viking’s once-daily oral VK2735 led to dose-dependent reductions in weight with greatest weight loss — an average 6.8% at 28 days — achieved in the highest of the eight doses tested. The results were presented Sunday during the ObesityWeek conference in San Antonio. Viking said Monday it plans to start a Phase 2 test of the tablet by the end of this year. Viking designed VK2735 to target and activate the GLP-1 and GIP receptors, the same receptors targeted by Eli Lilly’s injectable metabolic disorder drug tirzepatide, which is marketed as Zepbound for weight management. Viking has reached clinical testing with injectable and oral versions of its drug candidate. Sponsored Post The Future of Hospitals and Pharma Companies Will Depend on Strength of Healthcare Analytics Insights PurpleLab® stands out from others in this sector by providing its data analytics services to several different groups of users across healthcare and pharma companies. By Stephanie Baum This past spring, Viking reported preliminary Phase 1 data for oral VK2735 showing an average placebo-adjusted weight loss of 3.3% after 28 days. In those results, the highest of the five doses tested was 40 mg. The latest results add data for 27 total patients — nine in each of three additional dose groups. The average 6.8% weight reduction at 28 days was in the 100 mg cohort. Despite the higher doses in these cohorts, the study drug continued to be safe and well tolerated by patients. While gastrointestinal side effects are a known complication of currently available obesity meds, Viking reported that adverse events for oral VK2735 were classified as mild to moderate. Viking said weight loss persisted as observed in follow-up visits through day 57. Based on a preliminary evaluation of the trajectory of weight loss at multiple dose levels, the company believes continued treatment beyond four weeks may provide further reductions in weight. Viking’s injectable version of VK2735 is further along in clinical development. Earlier this year, Viking reported preliminary Phase 2 data showing patients who received the highest dose (a 13 mg injection once weekly) achieved a placebo-adjusted average weight loss of 13.1% measured at 13 weeks. Presentation of these results at ObesityWeek on Sunday included new pharmacokinetic data showing all patients who received the study drug maintained the majority of their weight loss four weeks after receiving their last dose of the drug in the clinical trial. Viking said it believes these results show the injectable drug could be dosed once-monthly as a maintenance treatment. Viking said Monday it plans to discuss with the FDA the clinical path forward for injectable VK2735. In a note sent to investors Monday, William Blair analyst Andy Hsieh said the 6.8% placebo-adjusted weight loss achieved for oral VK2735 topped investor expectations of 5% to 6%, which were set by Novo Nordisk pill amycretin, an experimental once-daily 100 mg drug designed to target the GLP-1 and amylin receptors. Other experimental pills that have posted encouraging clinical data in obesity this year include drug candidates from Roche, Structure Therapeutics, and Terns Pharma — all three of them oral GLP-1 receptor agonists. Kailera Therapeutics, which emerged from stealth last month with a lead program with in-licensed metabolic disorder drugs, has an oral GLP-1 and GIP receptor agonist in preclinical development. Hsieh said the value oral VK2735’s value could be in finding a place as a maintenance treatment following an active weight-loss phase with the injectable version of the drug. He believes Viking could be an attractive takeover target, given the Phase 3-ready status of injectable VK2735, the ability to offer a tablet formulation, plus another program ready to enter the clinic addressing the amylin receptor. presented by Health Tech What’s Keeping Healthcare CIOs Up at Night: How to Improve Patient Satisfaction by Handling Calls More Efficiently Health systems have spent billions on portals while investments in modernizing the voice channel — the dominant preference of healthcare consumers — have taken a backseat. By Stephanie Baum Leerink Partners analyst Thomas Smith said the weight loss achieved by oral VK2735 represents “stellar efficacy” and the greatest placebo-adjusted weight loss of any oral treatment to date. In a Monday note to investors, he highlighted the safety and tolerability results so far support potentially testing higher doses in subsequent studies. Regarding injectable VK2735, Smith expects the Phase 3 program will consist of two studies, one in type 2 diabetes and the other in obesity. “Overall, we believe these data reinforce best-in-class potential for VK2735, which has shown compelling weight loss and differentiated safety/tolerability in obese patients using both oral and subcutaneous formulations — an aspect we view as a key differentiator vs. competing obesity agents,” Smith wrote. “We expect these data will be favorably received by investors and anticipate strength in VKTX shares based on these updates. We expect VKTX will continue to unlock fundamental and strategic value for their obesity and metabolic disease programs heading into 2025, and we view oral ‘2735 as a potentially best-in-class agent across the oral obesity landscape.”

iStock, William_Potter Amid a flurry of weight loss readouts, a fresh-on-the-scene startup has come out with Phase I results showing weight loss at day 36 on par with or better than competitors, with few gastrointestinal side effects. Five months after launching, Metsera is making waves with Phase I results for a long-acting GLP-1 injectable showing a 7.5% reduction in body weight at day 36. The biotech said the results were as good as or better than approved or other similar clinical-stage GLP-1 compounds out there now. Notably, the trial did not involve titration—a period where a patient adjusts to the dose by slowly ramping up—which has been necessary for approved weight loss medicines and most in the clinic to ease common gastrointestinal side effects. Despite this, Metsera reported few such incidents among trial participants, and these were relatively mild. Metsera plans to move quickly to advance MET-097 based on the early-stage results, with a Phase IIb set to kick off in the fourth quarter and data expected in the first half of 2025. MET-097 is a long-acting injectable GLP-1 receptor agonist. The Phase I trial involved 125 adults who are healthy, non-diabetic and either overweight or obese. The participants received either single doses ranging from 0.16 mg to 1.6 mg or five weekly doses of 0.2 mg to 1.2 mg. At the 1.2 mg weekly dose, participants achieved 7.5% change in body weight compared to baseline at day 36, one week after the final dose. Metsera said this was consistent with or better than marketed products, which include Novo Nordisk’s Wegovy and Eli Lilly’s Zepbound, and other GLP-1/GIP compounds in clinical development. Cumulative weight loss in this dose group was 8.1% at day 57, four weeks after the last dose, which shows a durable effect from the therapy, Metsera said. As for safety, gastrointestinal adverse events were generally mild and dose-related. There were no severe treatment-emergent adverse events observed and no treatment-related discontinuations. Metsera Competes in Crowded Next-Gen Weight Loss Space Metsera’s results land amid a flurry of data readouts from next-gen candidates under development by small biotech peers and Big Pharma rivals. Terns Pharmaceuticals announced earlier this month that an investigational GLP-1 pill led to 4.9% weight loss after just 28 days. Meanwhile Novo Nordisk’s cannabinoid receptor 1 (CB1) inverse agonist cut weight by 15 lbs after 16 weeks of treatment, but participants reported neuropsychiatric side effects . Another Novo entrant, amycretin, achieved 13% weight loss at week 12. And trial participants taking Roche’s oral GLP-1 receptor agonist r apidly lost 7.3% of their body weight at four weeks but experienced challenging side effects. Metsera is one of the newest companies on the scene, having launched in April with $290 million in financing backed by Population Health Partners and ARCH Venture Partners. The company already had a GLP-1 portfolio in hand, including MET-097, whose Phase I trial was already underway when the company broke cover. “Metsera was purpose-built over the last two years to get ahead of the innovation curve in one of the largest and fastest growing markets in the history of biopharma,”  Metsera CEO Clive Meanwell said in an April statement.