SAN DIEGO - Viking Therapeutics, Inc. (NASDAQ: NASDAQ:VKTX) has announced positive results from its Phase 2b clinical trial of VK2809 for treating non-alcoholic steatohepatitis (NASH), also known as metabolic dysfunction associated steatohepatitis (MASH). The trial results were presented at the 75th Liver Meeting® 2024, organized by the American Association for the Study of Liver Diseases.
The VOYAGE study data revealed significant reductions in liver fat content over 52 weeks, with patients experiencing a mean relative change from baseline ranging from 37% to 55%. The response rate, defined as the proportion of patients with a reduction in liver fat ≥30%, ranged from 64% to 88% at Week 52, significantly better than placebo.
Secondary endpoints included NASH resolution without worsening of fibrosis and improvement in fibrosis without worsening of NASH. VK2809-treated patients showed NASH resolution rates between 63% to 75% and fibrosis improvement rates between 44% to 57%. Additionally, 44% of patients achieved both NASH resolution and fibrosis improvement.
The study also noted reductions in LDL-C (20% to 25%) and other atherogenic proteins, suggesting a potential cardioprotective effect of VK2809. The safety and tolerability profile of VK2809 was encouraging, with the majority of treatment-related adverse events reported as mild or moderate.
Dr. Rohit Loomba, Chief of Gastroenterology and Hepatology at UC San Diego School of Medicine, highlighted the therapeutic potential of VK2809, citing the "potent reductions in liver fat, impressive NASH resolution rates, and improvements in fibrosis."
Viking's CEO, Brian Lian, Ph.D., expressed confidence in VK2809's contribution to the company's pipeline programs for metabolic disorders. The VOYAGE study was a randomized, double-blind, placebo-controlled trial, including patients with biopsy-confirmed NASH/MASH and fibrosis, designed to evaluate the efficacy, safety, and tolerability of VK2809.
VK2809 is a liver-selective thyroid hormone receptor beta agonist that has demonstrated efficacy in reducing liver fat and improving lipid profiles, which could benefit patients with NASH/MASH and related metabolic disorders.
This report is based on a press release statement from Viking Therapeutics.
In other recent news, Viking Therapeutics has made significant strides in its clinical trials, with Laidlaw, Jefferies, and BTIG maintaining their Buy ratings on the company. Viking Therapeutics reported a net loss of $24.9 million for Q3 2024, with increased research and development expenses of $22.8 million and general and administrative expenses rising to $13.8 million. Despite these figures, the company's cash and equivalents remain strong at $930 million, supporting its future clinical trials.
Viking Therapeutics' drug candidate VK2735, developed for weight management, has shown promising results in recent studies. High doses of VK2735 have led to significant weight loss results at the four-week mark, alongside favorable gastrointestinal tolerability. This has bolstered confidence in the drug's progression to a Phase 2a clinical trial in the fourth quarter of 2024.
Analysts from Laidlaw, Jefferies, and BTIG expressed optimism about the drug's prospects, anticipating that VK2735 could position Viking competitively in the obesity treatment market. Furthermore, Viking plans to advance VK2735 into Phase 3 and initiate a Phase 2 obesity study for the same. These recent developments underscore Viking Therapeutics' progress in the field of obesity medication development.
InvestingPro Insights
Viking Therapeutics' positive Phase 2b clinical trial results for VK2809 in treating NASH/MASH have significant implications for the company's financial outlook. According to InvestingPro data, Viking's market capitalization stands at $5.72 billion, reflecting investor optimism about the company's potential in the lucrative NASH market.
Despite the promising clinical results, it's important to note that Viking Therapeutics is not currently profitable. InvestingPro Tips reveal that the company has not been profitable over the last twelve months, and analysts do not anticipate profitability this year. This is typical for biotech companies in the development stage, as they invest heavily in research and clinical trials.
However, Viking's financial position appears stable. An InvestingPro Tip indicates that the company holds more cash than debt on its balance sheet, which is crucial for funding ongoing research and potential commercialization efforts. Additionally, Viking's liquid assets exceed short-term obligations, providing financial flexibility as it advances its pipeline.
The stock's performance has been volatile recently, with InvestingPro data showing a 18.96% decline over the past week and a 25.36% drop over the last month. This contrasts sharply with the impressive 335.76% return over the past year, highlighting the potential for significant price swings in biotech stocks based on clinical trial results and market sentiment.
Investors should be aware that Viking Therapeutics is trading at a high Price/Book multiple of 6.28, suggesting high growth expectations are already priced into the stock. The company does not pay a dividend, which is common for growth-focused biotech firms reinvesting in their pipeline.
For those interested in a deeper analysis, InvestingPro offers 12 additional tips for Viking Therapeutics, providing a more comprehensive view of the company's financial health and market position.
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