Viking Therapeutics' Early Clinical Data Strengthen Case for Oral Obesity Drug

Viking Therapeutics is making significant strides in the development of oral medications for metabolic disorders, showing promising clinical data that some analysts believe could position its drug candidate, VK2735, as a leading oral obesity treatment. In a recent Phase 1 trial, the daily oral administration of VK2735 demonstrated dose-dependent weight reduction, with the highest dose resulting in an average weight loss of 6.8% over 28 days. These findings were shared during the ObesityWeek conference in San Antonio, and Viking announced plans to advance to Phase 2 testing by the end of the year.

VK2735 is designed to activate the GLP-1 and GIP receptors, mechanisms similar to those targeted by Eli Lilly's injectable drug tirzepatide (Zepbound) for weight management. Viking is exploring both injectable and oral versions of VK2735, aiming to offer versatile options for patients.

Earlier this year, Viking shared initial Phase 1 results for VK2735, which indicated an average placebo-adjusted weight loss of 3.3% at 28 days, with a maximum dose of 40 mg. The updated data now includes information from 27 patients across three additional dose groups, with the 100 mg dose showing the highest weight reduction. Despite the increased doses, the drug was well tolerated, with mild to moderate gastrointestinal side effects being the most common adverse events. Weight loss effects were sustained through follow-up visits on day 57, suggesting that extended treatment could potentially lead to further weight reduction.

Viking's injectable VK2735 is further along in development. Preliminary Phase 2 data revealed that patients on the highest dose (a 13 mg injection once weekly) achieved an average weight loss of 13.1% at 13 weeks compared to placebo. Additional pharmacokinetic data presented during ObesityWeek indicated that most patients maintained their weight loss four weeks after their last dose, hinting that a monthly maintenance dose could be effective. Viking plans to discuss the future clinical pathway for the injectable version with the FDA.

Analysts have taken note of VK2735's potential. William Blair analyst Andy Hsieh noted that the 6.8% weight loss observed in the recent oral study exceeded expectations, which were benchmarked at 5% to 6% based on Novo Nordisk's experimental drug amycretin. Hsieh also highlighted the potential use of oral VK2735 for maintaining weight loss achieved through its injectable counterpart, suggesting that Viking Therapeutics could become an attractive acquisition target due to their advancements in both formulations and their Phase 3-ready status.

Other companies developing oral GLP-1 receptor agonists, such as Roche, Structure Therapeutics, and Terns Pharma, have also shown promising results in obesity treatment this year. Additionally, Kailera Therapeutics, which recently emerged with a focus on metabolic disorder drugs, is developing an oral GLP-1 and GIP receptor agonist in preclinical stages.

Leerink Partners analyst Thomas Smith praised the efficacy of VK2735, calling its weight loss results "stellar" and the best seen in any oral treatment to date. He suggested that the current safety and tolerability data support the exploration of higher doses in future studies. Smith expects Viking's Phase 3 program for injectable VK2735 to include trials for both obesity and type 2 diabetes.

Overall, analysts believe VK2735 holds best-in-class potential due to its significant weight loss results and favorable safety profile in both oral and injectable forms. They anticipate positive reception from investors and foresee continued value growth for Viking Therapeutics' obesity and metabolic disease programs as they progress towards 2025.