Viking Therapeutics Shares New VK2735 Obesity Program Data at ObesityWeek® 2024

Viking Therapeutics, Inc., a San Diego-based biopharmaceutical company, recently unveiled new clinical data from its VK2735 obesity program during ObesityWeek 2024, the annual meeting of the Obesity Society. The data were shared through two poster presentations detailing the progress of both oral and subcutaneous formulations of VK2735, a dual agonist of GLP-1 and GIP receptors, which are being developed for various metabolic disorders.

The first poster, identified as Poster #017, presented findings from a Phase 1 multiple ascending dose (MAD) clinical trial which evaluated an oral tablet form of VK2735 administered daily for 28 days. The study examined cohorts receiving 60 mg, 80 mg, and 100 mg doses. Results indicated that participants experienced notable reductions in mean body weight, with the highest dose cohort showing up to an 8.2% reduction from baseline and a 6.8% reduction compared to placebo. Persistent weight loss was observed at follow-up visits up to 57 days, with sustained effects peaking at 8.3% from baseline. Additionally, up to 100% of VK2735-treated subjects achieved at least a 5% weight loss by Day 28, compared to none in the placebo group.

Safety and tolerability were also assessed, revealing that the majority of treatment-emergent adverse events (TEAEs) were mild or moderate. Gastrointestinal (GI) adverse events, though present, were predominantly mild. No severe nausea was reported, and incidences of vomiting and diarrhea were minimal. This encouraging safety profile supports the potential for VK2735 as a viable treatment for weight loss.

The second presentation, Poster #018, showcased updated results from the 13-week Phase 2 VENTURE study which involved subcutaneous injections of VK2735 in obese subjects. Participants receiving weekly doses exhibited significant reductions in mean body weight, achieving up to a 14.7% decrease from baseline. The weight loss was progressive over the study period, with many patients maintaining substantial weight reductions weeks after the last dose. The data suggested up to an 88% success rate for achieving at least a 10% weight loss among VK2735-treated patients, compared to just 4% in the placebo group.

Beyond weight loss, the VENTURE study assessed pharmacokinetic (PK) measures and diabetes status. The results indicated that a significant portion of the weight loss was maintained four weeks post-treatment, supporting the potential for a monthly maintenance dosing regimen. Additionally, VK2735 treatment reduced the likelihood of transitioning from prediabetic to diabetic status, highlighting its potential benefits for metabolic health beyond weight reduction.

Viking’s Chief Executive Officer, Brian Lian, Ph.D., expressed optimism about the results, noting the promising efficacy and tolerability of VK2735. The findings suggest that less frequent dosing could effectively maintain weight control, and upcoming discussions with the FDA will determine the clinical path forward for VK2735. Viking plans to initiate a Phase 2 study of the oral formulation by the end of the year, with detailed study designs to be disclosed closer to the initiation dates.

VK2735’s development is part of Viking’s broader effort to create innovative therapies for metabolic and endocrine disorders. The company’s pipeline includes other promising compounds such as VK2809 for lipid and metabolic disorders and VK0214 for X-linked adrenoleukodystrophy. Viking Therapeutics continues to leverage its expertise in metabolism to advance treatments aimed at improving patient outcomes in various metabolic conditions.