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.”

A scale and fat cells Taylor Tieden for BioSpace In this deep dive BioSpace dissects the global obesity and diabetes markets along with the growing pipelines that aim to serve them. The global obesity market is forecasted to reach between $100 billion and $160 billion in the next decade. Meanwhile, the market for type 2 diabetes, which is closely related, is predicted to exceed $70 billion by 2032. There is thus considerable opportunity for Novo Nordisk, Eli Lilly, Pfizer and the multitude of other biopharma companies vying for a piece of the lucrative pie. Weight-Loss Market Estimates and Projections Source: IQVIA, Reuters, Goldman Sachs Taylor Tieden for BioSpace While exceedingly successful, many suspect the current GLP-1 injection therapies for obesity will ultimately be replaced by oral GLP-1 drugs, and several companies, including Lilly, Novo and Pfizer, are racing to bring their versions to the market. In addition, the space is not limiting itself to GLP-1s but is also exploring novel mechanisms to tackle these widespread diseases. Here, BioSpace examines the current obesity and diabetes markets along with the growing pipelines that aim to serve them. Weight Loss: A Two-Horse Race The obesity market is currently dominated by two companies: Novo Nordisk and Eli Lilly. While Novo’s obesity drug Wegovy had a two-year head start on Lilly’s Zepbound, the latter is making up ground . On August 7, Novo reported its second-quarter earnings , revealing profits of $1.7 billion for Wegovy and $4.23 billion for diabetes drug Ozempic. Despite growth rates of 53% and 30%, respectively, for the drugs, investors were not impressed because analyst forecasts were missed. Lilly, on the other hand, beat Q2 expectations , bringing in $1.24 billion for Zepbound and $3.1 billion for diabetes treatment Mounjaro. But the future is much more than a two-horse race. Several companies, including Pfizer , Roche , Viking Therapeutics , and Rivus Pharmaceuticals, are developing obesity therapeutics. Some leverage the GLP-1 pathway, while others commit to different mechanisms, including amylin analogs and mitochondrial uncoupling. Other players in the space include Veru Pharmaceuticals, Regeneron, Altimmune, Amgen, and Amylyx. Approval Timeline The obesity space truly caught fire with the clinical success of Wegovy and Zepbound, but these products follow several other treatments for obesity and diabetes approved over the past two-plus decades. Here is a sampling of noteworthy products. November 2023 Eli Lilly, Zepbound Generic name: Tirzepatide Treatment: Weight management June 2022 Vivus, Qsymia Generic names: Phentermine and topiramate Treatment: Weight management in pediatric patients May 2022 Eli Lilly, Mounjaro Generic name: Tirzepatide Treatment: Type 2 diabetes June 2021 Novo Nordisk, Wegovy Generic name: Semaglutide Treatment: Obesity December 2020 Novo Nordisk, Saxenda Generic name: Liraglutide Treatment: Obesity in adolescents September 2019 Novo Nordisk, Rybelsus Generic name: Semaglutide Treatment: Type 2 diabetes (pill form) December 2017 Novo Nordisk, Ozempic Generic Name: semaglutide Treatment: Type 2 diabetes September 2014 Takeda, Contrave Generic names: Naltrexone and bupropion Treatment: Weight loss July 2012 Vivus, Qsymia Generic names: Phentermine and topiramate Treatment: Weight management in adult patients January 2010 Novo Nordisk, Victoza Generic name: Liraglutide Treatment: Type 2 diabetes April 2005 Amylin Pharmaceuticals, Byetta Generic name: Exenatide Treatment: Type 2 diabetes The Highly Sought Weight-Loss Pill In 2019, the FDA approved Novo’s Rybelsus as the first oral GLP-1 for type 2 diabetes. Considered by many to be the next frontier in obesity treatment, oral medicines are under development by a number of companies, including Novo, whose amycretin is in Phase I trials, and Lilly, which has a Phase III trial underway for orforglipron. Brazilian owned multinational company Eurofarma also has a Phase III study underway for its oral candidate sibutramine/topiramate XR. Meanwhile, a host of companies have oral assets in earlier-stage trials. Pfizer recently announced that it would move forward with a modified-release formulation of its candidate danuglipron, and in December 2023, San Francisco–based Structure Therapeutics announced positive results from a Phase IIa trial of its weight-loss pill GSBR-1290. Note: Not all companies with oral medicines in Phase I and II trials are included. Taylor Tieden for BioSpace Widely hailed as “the next big thing” in the obesity space, several companies—including Eli Lilly, Novo Nordisk and Pfizer—are developing oral GLP-1 candidates. How long before oral GLP-1s take majority share of the market? Source: BioSpace LinkedIn poll , August 2024 Taylor Tieden for BioSpace This deep dive was originally published as a special edition of ClinicaSpace. Subscribe here .