Obesity Drug VK2735 to Enter Phase 3, NASH Therapy VK2809 Shows Promising Results, and Novel Treatments in Development
Viking Therapeutics (VKTX), a clinical-stage biopharmaceutical company, has announced significant progress in its pipeline and financial performance for the first half of 2024. The company’s momentum is fueled by successful outcomes from multiple clinical trials, advancing novel therapies for metabolic and endocrine disorders, and robust financial health.
VK2735: Promising Obesity Treatment Moves to Phase 3
Subcutaneous VK2735 Viking Therapeutics’ lead obesity drug, VK2735, has shown impressive results in its Phase 2 VENTURE study. This study demonstrated that subcutaneous VK2735 led to a reduction of up to 15% in body weight from baseline over 13 weeks of dosing. The randomized, double-blind, placebo-controlled trial enrolled adults with obesity or overweight individuals with at least one weight-related comorbid condition. The study met all primary and secondary endpoints, with VK2735 achieving statistically significant weight loss compared to placebo. The drug also exhibited a favorable safety profile, with most adverse events being mild or moderate.
Following these encouraging results and feedback from an FDA Type C meeting, Viking is preparing to advance VK2735 into Phase 3 development. An end-of-Phase 2 meeting with the FDA is scheduled for later this year, where the design and timeline of the Phase 3 trial will be finalized.
Oral VK2735 Parallel to the subcutaneous formulation, Viking is also developing an oral tablet formulation of VK2735. In a Phase 1 study, the oral version showed positive safety, tolerability, and clinical activity, with subjects experiencing up to 5.3% weight loss from baseline over 28 days of daily dosing. Encouraged by these results, Viking plans to initiate a Phase 2 trial for the oral formulation in the fourth quarter of 2024.
VK2809: Advancing in NASH and Fibrosis Treatment
Viking’s thyroid hormone beta receptor agonist, VK2809, has demonstrated best-in-class efficacy in treating non-alcoholic steatohepatitis (NASH) and fibrosis. In the Phase 2b VOYAGE study, VK2809 achieved primary and secondary endpoints, showing significant reductions in liver fat and histologic improvements in NASH and fibrosis after 52 weeks of treatment.
Patients treated with VK2809 exhibited high rates of NASH resolution without worsening of fibrosis and notable improvements in fibrosis stages. Additionally, VK2809 improved cardiovascular biomarkers, suggesting potential long-term cardio-protective benefits. The drug was well tolerated with a favorable safety profile, and Viking plans to meet with the FDA in the fourth quarter of 2024 to discuss Phase 3 development.
VK0214: A Novel Approach to X-Linked Adrenoleukodystrophy
Viking’s VK0214 is an orally available thyroid hormone receptor beta agonist being evaluated for X-linked adrenoleukodystrophy (X-ALD), a rare neurodegenerative disease. The Phase 1b study, which has completed enrollment, focuses on the adrenomyeloneuropathy (AMN) form of X-ALD. The trial aims to assess the safety, tolerability, and pharmacokinetics of VK0214, with results expected in the second half of 2024.
Amylin Agonist Program: Preclinical Success
In June, Viking presented promising in vivo data from its novel amylin and calcitonin receptor agonist program at the American Diabetes Association conference. The preclinical studies demonstrated significant weight loss in animal models, supporting the potential of these agonists as a therapeutic option for obesity. Viking plans to file an Investigational New Drug (IND) application for this program in 2025.
Financial Performance
Viking’s financial health remains robust, with the company ending the second quarter of 2024 with $942 million in cash, cash equivalents, and short-term investments. This strong balance sheet provides the necessary runway to advance its pipeline programs. For the first half of 2024, Viking reported a net loss of $49.6 million, primarily due to increased research and development expenses. Despite the increased expenditures, the company’s financial position remains strong, allowing it to continue executing key milestones.
Looking Ahead
Viking Therapeutics’ diverse pipeline, encompassing therapies for obesity, NASH, X-ALD, and metabolic disorders, is progressing steadily through clinical development. The company’s ability to advance multiple programs simultaneously while maintaining financial stability highlights its potential to bring transformative treatments to patients in need. As Viking prepares for critical meetings with the FDA and initiates further trials, its commitment to innovation and patient care remains at the forefront of its mission.
With significant clinical advancements and a solid financial foundation, Viking Therapeutics is well-positioned to make impactful contributions to the treatment of metabolic and endocrine disorders. The upcoming Phase 3 trial for VK2735, promising data from VK2809, and the continued development of VK0214 and novel amylin agonists underscore the company’s potential to deliver groundbreaking therapies and improve patient outcomes in the near future.
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